Recovery MethodsNCT06613282
A Randomized, Single-blind Trial of LI-TMS and AVS for Stoke Recovery in Healthy Participants (Phase 1).
A study testing Low Intensity Transcranial Magnetic Stimulation and Auditory and visual stimulation in people with Recovery Methods and Rehabilitation Program, run by Siberian Scientific Research and Test Center for Biomedical Engineering at 1 site in Russia.
Trial summary
This randomized, controlled, single-blind clinical pilot study investigates the therapeutic potential of low-intensity repetitive transcranial magnetic stimulation (LI-TMS) and audio-visual stimulation (AVS) and newly offered interventional protocols in healthy participants for further research on stroke… Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Recovery Methods, Rehabilitation Program, Stroke, Ischemic
- What is being tested?
- Low Intensity Transcranial Magnetic Stimulation and Auditory and visual stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 16 Sep 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be in good general health, as verified by reviewing their medical history and physical examination. They must not have any serious illnesses that could be a barrier to the research.
Who cannot join
- somatic and neurological diseases in the exacerbation stage;
- presence of epileptic seizures on the EEG;
- cognitive disorders;
- presence of visual and hearing pathologies that prevent the sessions;
- women during pregnancy.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Novosibirsk State Medical University
Novosibirsk, Novosibirsk Oblast, 630091
About this study
Official title: A Randomized Single-blind Study of LI-TMS and AVS for Stroke Recovery in Healthy Participants with the Evaluation of the Effect on the Subject Using EEG and the Following Testing.
This randomized, controlled, single-blind clinical pilot study investigates the therapeutic potential of low-intensity repetitive transcranial magnetic stimulation (LI-TMS) and audio-visual stimulation (AVS) and newly offered interventional protocols in healthy participants for further research on stroke rehabilitation and therapeutic effects.
The goal of this clinical trial is to learn if the intervention can be used in the future treatment of patients recovering after stroke. It will also learn about the safety of low-intensity repetitive transcranial magnetic stimulation and audio-visual stimulation.
Read more
The main questions it aims to answer are:
Does intervention with LI-TMS and AVS influence the parameter Work Efficiency (WE) of the participant? Does intervention with LI-TMS and AVS influence the parameter Warming-up work indicator (WU) of the participant? Does intervention with LI-TMS and AVS influence the parameter Psychological Stability (PS) of the participant? Does intervention with LI-TMS and AVS influence the parameter Perceptual Accuracy (Tv) of the participant? Does intervention with LI-TMS and AVS affect changes in the participants electroencephalogram parameters? The researchers will compare the results of LI-TMS and AVS intervention to a control group that received no intervention but only underwent an examination to evaluate the effects of the interventions.
Participants will:
Receive interventions from LI-TMS and AVS every day for 2 weeks with a weekend break on Saturday and Sunday.
Attend the clinic 3 times during the trial and undergo testing and screening. The first clinic visit is before the intervention course. The second clinic visit will be the day immediately following the end of the two-week intervention course. The third visit will be two weeks after the second visit.
Read the detailed description
Stroke is a leading cause of disability worldwide, significantly impacting individuals; quality of life and their ability to perform daily activities. Rehabilitation is critical for stroke survivors as it aims to restore function, improve mobility, and enhance overall well-being.
Auditory-visual stimulation (AVS) is a stroke rehabilitation technique that combines auditory and visual stimuli to promote cognitive and motor recovery. This approach is based on the principles of neuroplasticity, which suggest that engaging multiple senses through receptor systems can promote brain plasticity and recovery after neurological injury such as stroke.
Transcranial Magnetic Stimulation (TMS) is a promising technique in stroke rehabilitation that involves applying magnetic fields to the scalp, which induces electrical currents in specific brain regions. This method is believed to facilitate neuroplasticity, the brains ability to reorganize itself by forming new neural connections.
LI-TMS is a variant of TMS that uses lower intensity magnetic fields. This technique is designed to minimize discomfort while still promoting neuroplasticity. Key aspects of LI-TMS include:
- Safety and Tolerability: LI-TMS is generally well-tolerated, making it suitable for patients who may be sensitive to higher-intensity stimulation.
- Potential for Long-Term Effects: Studies suggest that LI-TMS may lead to sustained improvements in motor function and cognitive abilities, even after treatment has ended.
- Combination with Other Therapies: LI-TMS can be effectively combined with traditional rehabilitation methods, enhancing overall therapeutic outcomes.
This study aims to test the proposed interventional protocols using a prototype device for low-intensity repetitive transcranial magnetic stimulation (LI-TMS) and audio-visual stimulation (AVS) on healthy participants.
Participants in the experimental group are screened and tested upon their first visit to the hospital. Afterward, intervention courses are run five days a week for two weeks. Activities take place on Monday, Tuesday, Wednesday, Thursday and Friday while Saturday and Sunday are free. Interventions of each protocol are applied for two days in routine. At the end of the intervention course, participants are screened and tested again at the hospital and after two weeks.
The following is how the Interventional procedure goes: first, the device will be plugged in and tested, then in 5 minutes the subject sits in a comfortable chair, further a disposable hair cap is put on his/her head, a textile helmet with coil emitters is put on top of the disposable hair cap, then glasses with Red, Green, Blue Light-emitting diodes and stereo headphones. The Interventional protocol was selected in prototype software. In conformance with the selected Interventional protocol, the characteristics of the exposure signal were then set up. The button on the prototypes touch screen was pressed next. The intervention procedure was stopped when the time on the timer on the touch screen of the prototype expired. When the exposure procedure was over, the prototype was switched off and all its exposure units were taken off of the test subject in reverse order.
The study will involve two groups: an experimental group and a control group. The experimental group, consisting of 30 healthy participants, will receive a course of interventions over two weeks of days. The comparison will be made with a control group consisting of 10 healthy participants who will receive no intervention, only screening, and testing.
Interventions. Experimental: Day 1 and Day 2
- For low-intensity transcranial magnetic stimulation, six radiating coils are placed in the temporal region above the hippocampus. A stimulation frequency of 6 Hz is applied to all emitters. The signal waveform to be used has a sinusoidal shape and bipolar type.
- For auditory stimulation, a binaural beats technique is used, where the frequency for the left ear is 440 Hz and for the right ear is 446 Hz. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For visual stimulation, the technique of different frequencies of the signals applied to the eyes is used, where the frequency for the left eye is 1 Hz and for the right eye is 7 Hz. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For colour stimulation, the left eye is exposed to blue for 6 minutes in the initial stage and green for 6 minutes in the final stage. The right eye is exposed to the colour green for 6 minutes in the initial stage and blue for 6 minutes in the final stage as well.
- The total time duration of the procedure is 12 minutes. Experimental: Day 3 and Day 4
- For low-intensity transcranial magnetic stimulation, six radiating coils are placed in the temporal region above the hippocampus. The frequencies of the stimulation signal are varied as follows: at the initial stage the signal frequency is 4 Hz is applied to all emitters and lasts for 6 minutes, then the frequency increases to 5 Hz for the next 6 minutes, then to 6 Hz for the next 6 minutes, then to 7 Hz for the next 6 minutes, and at the final stage the signal frequency is 8 Hz and lasts for 6 minutes. The signal waveform to be used has a sinusoidal shape and bipolar type.
- For auditory stimulation, a binaural beats technique is used, where the frequency for the left ear in the initial stage is 440 Hz and for the right ear is 444 Hz, and lasts for 6 minutes. In the next stage, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 445 Hz, and lasts for 6 minutes. Next, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 446 Hz, and lasts 6 minutes. Then the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 447 Hz, and lasts for 6 minutes. In the final stage, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 448 Hz, and lasts for 6 minutes. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For visual stimulation, the technique of different frequencies of the signals applied to the eyes is used, where the frequency for the left eye in the initial stage is 1 Hz and for the right eye is 5 Hz and lasts for 6 minutes. In the next stage, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 6 Hz, and lasts for 6 minutes. Next, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 7 Hz, and lasts for 6 minutes. Then the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 8 Hz, and lasts for 6 minutes. In the final stage, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 9 Hz, and lasts for 6 minutes. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For colour stimulation, the left eye is exposed to red in the initial stage and the right eye is exposed to green, and lasts for 6 minutes. In the next stage, the left eye is exposed to the colour blue and the right eye is exposed to the colour violet and lasts for 6 minutes. Next, the left eye is exposed to the colour green and the right eye is exposed to the colour blue, and lasts for 6 minutes. Then the left eye is exposed to the colour violet and the right eye is exposed to the colour green, and lasts for 6 minutes. In the final stage, the left eye is exposed to the colour green and the right eye to the colour red, and lasts for 6 minutes.
- The total time duration of the procedure is 30 minutes. Experimental: Day 5
- For low-intensity transcranial magnetic stimulation, six radiating coils are placed in the temporal region above the hippocampus. Frequencies of the stimulation signal are varied as follows: in the initial stage, the carrier frequency of the signal is 8 Hz and the modulating frequency is 4 Hz, and lasts for 6 minutes. In the next stage, the carrier frequency of the signal stays 8 Hz and the modulating frequency increases to 5 Hz, and lasts for 6 minutes. Next, the carrier frequency of the signal stays 8 Hz, and the modulating frequency is increased to 6 Hz, and lasts for 6 minutes. Then the carrier frequency of the signal stays 8 Hz, and the modulating frequency is increased to 7 Hz, and lasts for 6 minutes. In the final step, the signal carrier frequency and modulating frequency are equal to 8 Hz, resulting in the signal being a regular sinusoid with a frequency of 8 Hz, and lasting 6 minutes. Carrier signal waveform - sine wave, modulating signal waveform - cosine wave. The signal type is bipolar.
- For auditory stimulation, a binaural beats technique is used, where the frequency for the left ear in the initial stage is 440 Hz and for the right ear is 444 Hz, and lasts for 6 minutes. In the next stage, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 445 Hz, and lasts for 6 minutes. Next, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 446 Hz, and lasts 6 minutes. Then the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 447 Hz, and lasts for 6 minutes. In the final stage, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 448 Hz, and lasts for 6 minutes. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For visual stimulation, the technique of different frequencies of the signals applied to the eyes is used, where the frequency for the left eye in the initial stage is 1 Hz and for the right eye is 5 Hz and lasts for 6 minutes. In the next stage, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 6 Hz, and lasts for 6 minutes. Next, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 7 Hz, and lasts for 6 minutes. Then the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 8 Hz, and lasts for 6 minutes. In the final stage, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 9 Hz, and lasts for 6 minutes. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For colour stimulation, the left eye is exposed to red in the initial stage and the right eye is exposed to green, and lasts for 6 minutes. In the next stage, the left eye is exposed to the colour blue and the right eye is exposed to the colour violet and lasts for 6 minutes. Next, the left eye is exposed to the colour green and the right eye is exposed to the colour blue, and lasts for 6 minutes. Then the left eye is exposed to the colour violet and the right eye is exposed to the colour green, and lasts for 6 minutes. In the final stage, the left eye is exposed to the colour green and the right eye to the colour red, and lasts for 6 minutes.
- The total time duration of the procedure is 30 minutes. Experimental: Day 6 Day of no interventions. Experimental: Day 7 Day of no interventions. Experimental: Day 8
- For low-intensity transcranial magnetic stimulation, six radiating coils are placed in the temporal region above the hippocampus. Frequencies of the stimulation signal are varied as follows: in the initial stage, the carrier frequency of the signal is 8 Hz and the modulating frequency is 4 Hz, and lasts for 6 minutes. In the next stage, the carrier frequency of the signal stays 8 Hz and the modulating frequency increases to 5 Hz, and lasts for 6 minutes. Next, the carrier frequency of the signal stays 8 Hz, and the modulating frequency is increased to 6 Hz, and lasts for 6 minutes. Then the carrier frequency of the signal stays 8 Hz, and the modulating frequency is increased to 7 Hz, and lasts for 6 minutes. In the final step, the signal carrier frequency and modulating frequency are equal to 8 Hz, resulting in the signal being a regular sinusoid with a frequency of 8 Hz, and lasting 6 minutes. Carrier signal waveform - sine wave, modulating signal waveform - cosine wave. The signal type is bipolar.
- For auditory stimulation, a binaural beats technique is used, where the frequency for the left ear in the initial stage is 440 Hz and for the right ear is 444 Hz, and lasts for 6 minutes. In the next stage, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 445 Hz, and lasts for 6 minutes. Next, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 446 Hz, and lasts 6 minutes. Then the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 447 Hz, and lasts for 6 minutes. In the final stage, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 448 Hz, and lasts for 6 minutes. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For visual stimulation, the technique of different frequencies of the signals applied to the eyes is used, where the frequency for the left eye in the initial stage is 1 Hz and for the right eye is 5 Hz and lasts for 6 minutes. In the next stage, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 6 Hz, and lasts for 6 minutes. Next, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 7 Hz, and lasts for 6 minutes. Then the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 8 Hz, and lasts for 6 minutes. In the final stage, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 9 Hz, and lasts for 6 minutes. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For colour stimulation, the left eye is exposed to red in the initial stage and the right eye is exposed to green, and lasts for 6 minutes. In the next stage, the left eye is exposed to the colour blue and the right eye is exposed to the colour violet and lasts for 6 minutes. Next, the left eye is exposed to the colour green and the right eye is exposed to the colour blue, and lasts for 6 minutes. Then the left eye is exposed to the colour violet and the right eye is exposed to the colour green, and lasts for 6 minutes. In the final stage, the left eye is exposed to the colour green and the right eye to the colour red, and lasts for 6 minutes.
- The total time duration of the procedure is 30 minutes. Experimental: Day 9 and Day 10
- For low-intensity transcranial magnetic stimulation involved all 32 magnetic emitters located over the entire scalp area. The stimulation frequencies were as follows: the carrier signal frequency was 13 Hz, and the modulating signal frequency was determined by the operator based on the participants previously measured electroencephalogram (e.g., 9 Hz). The shape of the carrier signal was a sine wave, and the shape of the modulating signal was a cosine wave. The signal type is bipolar. Carrier signal waveform - sine wave, modulating signal waveform - cosine wave. The signal type is bipolar.
- For auditory stimulation, a binaural beats technique is used, where the frequency for the left ear is 440 Hz and for the right ear is (440 + n) Hz, where n is a frequency value determined by the operator based on the participants previously measured electroencephalogram (e.g., 9 Hz). The signal waveform to be used has a sinusoidal shape and unipolar type.
- For visual stimulation, the technique of different frequencies of the signals applied to the eyes is used, where the frequency for the left eye is 1 Hz and for the right eye is (1 + n) Hz, where n represents a frequency value determined by the operator based on the participants previously measured electroencephalogram (e.g., 9 Hz). The signal waveform to be used has a sinusoidal shape and unipolar type.
- For colour stimulation, the left eye is exposed to blue for 6 minutes in the initial stage and green for 6 minutes in the final stage. The right eye is exposed to the colour green for 6 minutes in the initial stage and blue for 6 minutes in the final stage as well.
- The total time duration of the procedure is 12 minutes. Experimental: Day 11 and Day 12
- For low-intensity transcranial magnetic stimulation involved all 32 magnetic emitters located over the entire scalp area. The stimulation frequencies were as follows: the carrier signal frequency was 25 Hz, and the modulating signal frequency was determined by the operator based on the participants previously measured electroencephalogram (e.g., 14 Hz). The shape of the carrier signal was a sine wave, and the shape of the modulating signal was a cosine wave. The signal type is bipolar. Carrier signal waveform - sine wave, modulating signal waveform - cosine wave. The signal type is bipolar.
- For auditory stimulation, a binaural beats technique is used, where the frequency for the left ear is 440 Hz and for the right ear is (440 + n) Hz, where n is a frequency value determined by the operator based on the participants previously measured electroencephalogram (e.g., 14 Hz). The signal waveform to be used has a sinusoidal shape and unipolar type.
- For visual stimulation, the technique of different frequencies of the signals applied to the eyes is used, where the frequency for the left eye is 1 Hz and for the right eye is (1 + n) Hz, where n represents a frequency value determined by the operator based on the participants previously measured electroencephalogram (e.g., 14 Hz). The signal waveform to be used has a sinusoidal shape and unipolar type.
- For colour stimulation, the left eye is exposed to blue for 6 minutes in the initial stage and green for 6 minutes in the final stage. The right eye is exposed to the colour green for 6 minutes in the initial stage and blue for 6 minutes in the final stage as well.
- The total time duration of the procedure is 12 minutes. Experimental: Day 13 Day of no interventions. Experimental: Day 14 Day of no interventions.
Control: Day 1 - Day 14 The control group does not receive any intervention for 14 days.
Participants in the experimental group and control group are screened and tested on the first day and on day fourteen and on day 28th of the study.
- Conditions
- Recovery Methods, Rehabilitation Program, Stroke, Ischemic, Stroke
- Being tested
- Low Intensity Transcranial Magnetic Stimulation, Auditory and visual stimulation
- Keywords
- Low Intensity Transcranial Magnetic Stimulation, audio-visual stimulation, AVS, recovery after stroke, stroke rehabilitation, LI-TMS
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity Transcranial Magnetic StimulationDevice
Also called LI-TMS
- Magnetic stimulation frequency range: 0.1 - 700 Hz.
- Amplitude of the magnetic field at a short distance from the magnetic coil: 1-5 milliTesla.
- Emitter coil dimensions: ⌀28×26 mm.
- Number of emitter coils: 32 coils.
- Covering the entire scalp of a human head with 32 coil emitters.
Auditory and visual stimulationDevice
- Frequency range of light stimulation: 0.1 - 60 Hz.
- Audio stimulation frequency range: 20 - 2000 Hz.
- Sound level: 70 Decibel.
- The wavelength range of visual stimulation: red - 620 - 760 nm; green - 510 - 550 nm; blue - 450 - 480 nm.
- Illuminance: 300 - 350 lx.
| Study group | Role | What they receive |
|---|---|---|
| LI-TMS and AVS | Experimental | Participants receive low-intensity transcranial magnetic stimulation interventions with audio-visual stimulation for 14 days. On days 6, 7, 13, and 14 of the study, participants will not receive any interventions. Participants will be screened and tested on days 1 and 14 of treatment and two weeks after the end of the intervention. Receives: Device: Low Intensity Transcranial Magnetic Stimulation; Device: Auditory and visual stimulation |
| Control | No intervention | Participants receive no interventions for 14 days. Participants will be screened and tested on days 1, 14 and 28. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Efficiency (WE)
Work Efficiency (WE) is a key parameter derived from the Schulte table test that quantifies the effectiveness of a participants performance during the test. It reflects the relationship between the number of correct responses and the time taken to complete the task.
Calculation of Work Efficiency is calculated using the following formula:
WE= T/N.
Where:
N = the number of tables completed by the participant. T = Time taken to complete the test (measured in seconds). This formula indicates that Work Efficiency increases with either a higher number of correct responses or a shorter completion time.
Measurement Units Values in the range of 30 to 50 seconds are good result. Values above 90 seconds are a negative result. Better result of WE suggest better cognitive efficiency and processing speed, while worse result may indicate difficulties in attention or visual processing.
Measured: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Warming-up Work Indicator (WU)
Warming-up Work Indicator (WU) indicates the amount of effort or cognitive load that an individual expends during the initial phase of the test.
Calculation of WU The WU is typically calculated based on the time taken to complete the first task of the Schulte table test compared to the overall time taken for the entire test.
The first tasks time is compared with the average WE time. A WU ratio close to 1 indicates the best possible preparation of the participant, whereas ratios above 1 indicate that more time needs to be taken as a warm-up before optimal performance.
WU = T1 / WE Measurement Units A result less than 1.0 is an indicator of good Warming-up Work Indicator; accordingly, the higher 1.0 this indicator is, the more the subject needs preparation for the main job.
Measured: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Psychological Stability (PS)
Psychological Stability (PS) is a parameter derived from the Schulte table test that assesses the ability to sustain the operational activity for a long time. It reflects how well a participant can manage distractions and maintain attention throughout the test.
Calculation:
PS =T(n-1) /WE. Measurement Units. Psychological Stability does not have a standardized unit of measurement; rather, it is often expressed as a score or index that can be compared across individuals or populations.
Measurement Units The result indicator less than 1.0 indicates good Psychological Stability, accordingly, the higher this indicator is, the worse the Psychological Stability of the test subject to perform the tasks.
Measured: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Attention switching time (t)
The Test of Attention Switching Time Using Black-Red Table is a psychological assessment designed to measure the efficiency of attention switching in individuals. Attention switching time (t) refers to the duration it takes for an individual to shift their focus from one task or stimulus to another. It is a critical parameter in cognitive psychology, as it reflects the efficiency of an individuals cognitive processing and ability to manage attention in dynamic environments.
Calculation:
The difference between the time required to complete the last task and the sum of the time spent working on the first and the second task will be the time the subject spends switching attention from one activity to another.
Measurement Units A shorter completion time of the Attentional Switching Time Test using the Black-Red Tables indicates better attentional switching ability.
Measured: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Perceptual Accuracy (Tv)
The Memorize and Place Shapes task is a cognitive assessment designed to evaluate spatial memory and perceptual accuracy.
Perceptual Accuracy (Tv) refers to the precision with which an individual can recognize and reproduce shapes after they have been memorized. This parameter is crucial in understanding cognitive functions related to memory and visual processing.
Calculation:
The result is an overall calculation made from the complete number of dots correctly placed on all forms. Among others, the following is calculated: Perceptual accuracy: Tv = (∑ / n) * 100, where ∑ is the total number of correctly filled-in Remember and dot test forms and n is the number of dot cards viewed. Multiply the result of the division by 100 to obtain the perceptual accuracy in percent.
Measurement Units The higher the Perceptual Accuracy (Tv) score on the Memorise and Place Shapes test, the better the participant\'s visual perception.
Measured: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Secondary outcomes (1)
EEG
Standard procedure for recording an electroencephalogram.
Measured: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start16 Sep 2024
- Primary completion15 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recovery MethodsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siberian Scientific Research and Test Center for Biomedical Engineering
- Sponsor type
- University, hospital or other
- Collaborators
- Novosibirsk State Medical University
- Responsible party
- Principal investigator, Viktor Anatolyevich Drobyshev, Siberian Scientific Research and Test Center for Biomedical Engineering
- Investigators
- Viktor Drobyshev, Dr. Med. Sc., Principal investigator, Novosibirsk State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613282
- Sponsor's protocol ID
- LI-TMS and AVS for recovery
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual patient data that underline results in a publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single-blind Study of LI-TMS and AVS for Stroke Recovery in Healthy Participants with the Evaluation of the Effect on the Subject Using EEG and the Following Testing.
- ClinicalTrials.gov ID
- NCT06613282
- Acronym / sponsor ID
- LI-TMS and AVS for recovery
- Conditions
- Recovery Methods, Rehabilitation Program, Stroke, Ischemic, Stroke
- Keywords
- Low Intensity Transcranial Magnetic Stimulation, audio-visual stimulation, AVS, recovery after stroke, stroke rehabilitation, LI-TMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Siberian Scientific Research and Test Center for Biomedical EngineeringUniversity, hospital or other
- Collaborators
- Novosibirsk State Medical University
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, controlled, single-blind clinical pilot study investigates the therapeutic potential of low-intensity repetitive transcranial magnetic stimulation (LI-TMS) and audio-visual stimulation (AVS) and newly offered interventional protocols in healthy participants for further research on stroke rehabilitation and therapeutic effects.
The goal of this clinical trial is to learn if the intervention can be used in the future treatment of patients recovering after stroke. It will also learn about the safety of low-intensity repetitive transcranial magnetic stimulation and audio-visual stimulation.
The main questions it aims to answer are:
Does intervention with LI-TMS and AVS influence the parameter Work Efficiency (WE) of the participant? Does intervention with LI-TMS and AVS influence the parameter Warming-up work indicator (WU) of the participant? Does intervention with LI-TMS and AVS influence the parameter Psychological Stability (PS) of the participant? Does intervention with LI-TMS and AVS influence the parameter Perceptual Accuracy (Tv) of the participant? Does intervention with LI-TMS and AVS affect changes in the participants electroencephalogram parameters? The researchers will compare the results of LI-TMS and AVS intervention to a control group that received no intervention but only underwent an examination to evaluate the effects of the interventions.
Participants will:
Receive interventions from LI-TMS and AVS every day for 2 weeks with a weekend break on Saturday and Sunday.
Attend the clinic 3 times during the trial and undergo testing and screening. The first clinic visit is before the intervention course. The second clinic visit will be the day immediately following the end of the two-week intervention course. The third visit will be two weeks after the second visit.
Detailed description
Stroke is a leading cause of disability worldwide, significantly impacting individuals; quality of life and their ability to perform daily activities. Rehabilitation is critical for stroke survivors as it aims to restore function, improve mobility, and enhance overall well-being.
Auditory-visual stimulation (AVS) is a stroke rehabilitation technique that combines auditory and visual stimuli to promote cognitive and motor recovery. This approach is based on the principles of neuroplasticity, which suggest that engaging multiple senses through receptor systems can promote brain plasticity and recovery after neurological injury such as stroke.
Transcranial Magnetic Stimulation (TMS) is a promising technique in stroke rehabilitation that involves applying magnetic fields to the scalp, which induces electrical currents in specific brain regions. This method is believed to facilitate neuroplasticity, the brains ability to reorganize itself by forming new neural connections.
LI-TMS is a variant of TMS that uses lower intensity magnetic fields. This technique is designed to minimize discomfort while still promoting neuroplasticity. Key aspects of LI-TMS include:
- Safety and Tolerability: LI-TMS is generally well-tolerated, making it suitable for patients who may be sensitive to higher-intensity stimulation.
- Potential for Long-Term Effects: Studies suggest that LI-TMS may lead to sustained improvements in motor function and cognitive abilities, even after treatment has ended.
- Combination with Other Therapies: LI-TMS can be effectively combined with traditional rehabilitation methods, enhancing overall therapeutic outcomes.
This study aims to test the proposed interventional protocols using a prototype device for low-intensity repetitive transcranial magnetic stimulation (LI-TMS) and audio-visual stimulation (AVS) on healthy participants.
Participants in the experimental group are screened and tested upon their first visit to the hospital. Afterward, intervention courses are run five days a week for two weeks. Activities take place on Monday, Tuesday, Wednesday, Thursday and Friday while Saturday and Sunday are free. Interventions of each protocol are applied for two days in routine. At the end of the intervention course, participants are screened and tested again at the hospital and after two weeks.
The following is how the Interventional procedure goes: first, the device will be plugged in and tested, then in 5 minutes the subject sits in a comfortable chair, further a disposable hair cap is put on his/her head, a textile helmet with coil emitters is put on top of the disposable hair cap, then glasses with Red, Green, Blue Light-emitting diodes and stereo headphones. The Interventional protocol was selected in prototype software. In conformance with the selected Interventional protocol, the characteristics of the exposure signal were then set up. The button on the prototypes touch screen was pressed next. The intervention procedure was stopped when the time on the timer on the touch screen of the prototype expired. When the exposure procedure was over, the prototype was switched off and all its exposure units were taken off of the test subject in reverse order.
The study will involve two groups: an experimental group and a control group. The experimental group, consisting of 30 healthy participants, will receive a course of interventions over two weeks of days. The comparison will be made with a control group consisting of 10 healthy participants who will receive no intervention, only screening, and testing.
Interventions. Experimental: Day 1 and Day 2
- For low-intensity transcranial magnetic stimulation, six radiating coils are placed in the temporal region above the hippocampus. A stimulation frequency of 6 Hz is applied to all emitters. The signal waveform to be used has a sinusoidal shape and bipolar type.
- For auditory stimulation, a binaural beats technique is used, where the frequency for the left ear is 440 Hz and for the right ear is 446 Hz. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For visual stimulation, the technique of different frequencies of the signals applied to the eyes is used, where the frequency for the left eye is 1 Hz and for the right eye is 7 Hz. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For colour stimulation, the left eye is exposed to blue for 6 minutes in the initial stage and green for 6 minutes in the final stage. The right eye is exposed to the colour green for 6 minutes in the initial stage and blue for 6 minutes in the final stage as well.
- The total time duration of the procedure is 12 minutes. Experimental: Day 3 and Day 4
- For low-intensity transcranial magnetic stimulation, six radiating coils are placed in the temporal region above the hippocampus. The frequencies of the stimulation signal are varied as follows: at the initial stage the signal frequency is 4 Hz is applied to all emitters and lasts for 6 minutes, then the frequency increases to 5 Hz for the next 6 minutes, then to 6 Hz for the next 6 minutes, then to 7 Hz for the next 6 minutes, and at the final stage the signal frequency is 8 Hz and lasts for 6 minutes. The signal waveform to be used has a sinusoidal shape and bipolar type.
- For auditory stimulation, a binaural beats technique is used, where the frequency for the left ear in the initial stage is 440 Hz and for the right ear is 444 Hz, and lasts for 6 minutes. In the next stage, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 445 Hz, and lasts for 6 minutes. Next, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 446 Hz, and lasts 6 minutes. Then the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 447 Hz, and lasts for 6 minutes. In the final stage, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 448 Hz, and lasts for 6 minutes. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For visual stimulation, the technique of different frequencies of the signals applied to the eyes is used, where the frequency for the left eye in the initial stage is 1 Hz and for the right eye is 5 Hz and lasts for 6 minutes. In the next stage, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 6 Hz, and lasts for 6 minutes. Next, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 7 Hz, and lasts for 6 minutes. Then the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 8 Hz, and lasts for 6 minutes. In the final stage, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 9 Hz, and lasts for 6 minutes. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For colour stimulation, the left eye is exposed to red in the initial stage and the right eye is exposed to green, and lasts for 6 minutes. In the next stage, the left eye is exposed to the colour blue and the right eye is exposed to the colour violet and lasts for 6 minutes. Next, the left eye is exposed to the colour green and the right eye is exposed to the colour blue, and lasts for 6 minutes. Then the left eye is exposed to the colour violet and the right eye is exposed to the colour green, and lasts for 6 minutes. In the final stage, the left eye is exposed to the colour green and the right eye to the colour red, and lasts for 6 minutes.
- The total time duration of the procedure is 30 minutes. Experimental: Day 5
- For low-intensity transcranial magnetic stimulation, six radiating coils are placed in the temporal region above the hippocampus. Frequencies of the stimulation signal are varied as follows: in the initial stage, the carrier frequency of the signal is 8 Hz and the modulating frequency is 4 Hz, and lasts for 6 minutes. In the next stage, the carrier frequency of the signal stays 8 Hz and the modulating frequency increases to 5 Hz, and lasts for 6 minutes. Next, the carrier frequency of the signal stays 8 Hz, and the modulating frequency is increased to 6 Hz, and lasts for 6 minutes. Then the carrier frequency of the signal stays 8 Hz, and the modulating frequency is increased to 7 Hz, and lasts for 6 minutes. In the final step, the signal carrier frequency and modulating frequency are equal to 8 Hz, resulting in the signal being a regular sinusoid with a frequency of 8 Hz, and lasting 6 minutes. Carrier signal waveform - sine wave, modulating signal waveform - cosine wave. The signal type is bipolar.
- For auditory stimulation, a binaural beats technique is used, where the frequency for the left ear in the initial stage is 440 Hz and for the right ear is 444 Hz, and lasts for 6 minutes. In the next stage, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 445 Hz, and lasts for 6 minutes. Next, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 446 Hz, and lasts 6 minutes. Then the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 447 Hz, and lasts for 6 minutes. In the final stage, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 448 Hz, and lasts for 6 minutes. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For visual stimulation, the technique of different frequencies of the signals applied to the eyes is used, where the frequency for the left eye in the initial stage is 1 Hz and for the right eye is 5 Hz and lasts for 6 minutes. In the next stage, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 6 Hz, and lasts for 6 minutes. Next, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 7 Hz, and lasts for 6 minutes. Then the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 8 Hz, and lasts for 6 minutes. In the final stage, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 9 Hz, and lasts for 6 minutes. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For colour stimulation, the left eye is exposed to red in the initial stage and the right eye is exposed to green, and lasts for 6 minutes. In the next stage, the left eye is exposed to the colour blue and the right eye is exposed to the colour violet and lasts for 6 minutes. Next, the left eye is exposed to the colour green and the right eye is exposed to the colour blue, and lasts for 6 minutes. Then the left eye is exposed to the colour violet and the right eye is exposed to the colour green, and lasts for 6 minutes. In the final stage, the left eye is exposed to the colour green and the right eye to the colour red, and lasts for 6 minutes.
- The total time duration of the procedure is 30 minutes. Experimental: Day 6 Day of no interventions. Experimental: Day 7 Day of no interventions. Experimental: Day 8
- For low-intensity transcranial magnetic stimulation, six radiating coils are placed in the temporal region above the hippocampus. Frequencies of the stimulation signal are varied as follows: in the initial stage, the carrier frequency of the signal is 8 Hz and the modulating frequency is 4 Hz, and lasts for 6 minutes. In the next stage, the carrier frequency of the signal stays 8 Hz and the modulating frequency increases to 5 Hz, and lasts for 6 minutes. Next, the carrier frequency of the signal stays 8 Hz, and the modulating frequency is increased to 6 Hz, and lasts for 6 minutes. Then the carrier frequency of the signal stays 8 Hz, and the modulating frequency is increased to 7 Hz, and lasts for 6 minutes. In the final step, the signal carrier frequency and modulating frequency are equal to 8 Hz, resulting in the signal being a regular sinusoid with a frequency of 8 Hz, and lasting 6 minutes. Carrier signal waveform - sine wave, modulating signal waveform - cosine wave. The signal type is bipolar.
- For auditory stimulation, a binaural beats technique is used, where the frequency for the left ear in the initial stage is 440 Hz and for the right ear is 444 Hz, and lasts for 6 minutes. In the next stage, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 445 Hz, and lasts for 6 minutes. Next, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 446 Hz, and lasts 6 minutes. Then the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 447 Hz, and lasts for 6 minutes. In the final stage, the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 448 Hz, and lasts for 6 minutes. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For visual stimulation, the technique of different frequencies of the signals applied to the eyes is used, where the frequency for the left eye in the initial stage is 1 Hz and for the right eye is 5 Hz and lasts for 6 minutes. In the next stage, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 6 Hz, and lasts for 6 minutes. Next, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 7 Hz, and lasts for 6 minutes. Then the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 8 Hz, and lasts for 6 minutes. In the final stage, the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 9 Hz, and lasts for 6 minutes. The signal waveform to be used has a sinusoidal shape and unipolar type.
- For colour stimulation, the left eye is exposed to red in the initial stage and the right eye is exposed to green, and lasts for 6 minutes. In the next stage, the left eye is exposed to the colour blue and the right eye is exposed to the colour violet and lasts for 6 minutes. Next, the left eye is exposed to the colour green and the right eye is exposed to the colour blue, and lasts for 6 minutes. Then the left eye is exposed to the colour violet and the right eye is exposed to the colour green, and lasts for 6 minutes. In the final stage, the left eye is exposed to the colour green and the right eye to the colour red, and lasts for 6 minutes.
- The total time duration of the procedure is 30 minutes. Experimental: Day 9 and Day 10
- For low-intensity transcranial magnetic stimulation involved all 32 magnetic emitters located over the entire scalp area. The stimulation frequencies were as follows: the carrier signal frequency was 13 Hz, and the modulating signal frequency was determined by the operator based on the participants previously measured electroencephalogram (e.g., 9 Hz). The shape of the carrier signal was a sine wave, and the shape of the modulating signal was a cosine wave. The signal type is bipolar. Carrier signal waveform - sine wave, modulating signal waveform - cosine wave. The signal type is bipolar.
- For auditory stimulation, a binaural beats technique is used, where the frequency for the left ear is 440 Hz and for the right ear is (440 + n) Hz, where n is a frequency value determined by the operator based on the participants previously measured electroencephalogram (e.g., 9 Hz). The signal waveform to be used has a sinusoidal shape and unipolar type.
- For visual stimulation, the technique of different frequencies of the signals applied to the eyes is used, where the frequency for the left eye is 1 Hz and for the right eye is (1 + n) Hz, where n represents a frequency value determined by the operator based on the participants previously measured electroencephalogram (e.g., 9 Hz). The signal waveform to be used has a sinusoidal shape and unipolar type.
- For colour stimulation, the left eye is exposed to blue for 6 minutes in the initial stage and green for 6 minutes in the final stage. The right eye is exposed to the colour green for 6 minutes in the initial stage and blue for 6 minutes in the final stage as well.
- The total time duration of the procedure is 12 minutes. Experimental: Day 11 and Day 12
- For low-intensity transcranial magnetic stimulation involved all 32 magnetic emitters located over the entire scalp area. The stimulation frequencies were as follows: the carrier signal frequency was 25 Hz, and the modulating signal frequency was determined by the operator based on the participants previously measured electroencephalogram (e.g., 14 Hz). The shape of the carrier signal was a sine wave, and the shape of the modulating signal was a cosine wave. The signal type is bipolar. Carrier signal waveform - sine wave, modulating signal waveform - cosine wave. The signal type is bipolar.
- For auditory stimulation, a binaural beats technique is used, where the frequency for the left ear is 440 Hz and for the right ear is (440 + n) Hz, where n is a frequency value determined by the operator based on the participants previously measured electroencephalogram (e.g., 14 Hz). The signal waveform to be used has a sinusoidal shape and unipolar type.
- For visual stimulation, the technique of different frequencies of the signals applied to the eyes is used, where the frequency for the left eye is 1 Hz and for the right eye is (1 + n) Hz, where n represents a frequency value determined by the operator based on the participants previously measured electroencephalogram (e.g., 14 Hz). The signal waveform to be used has a sinusoidal shape and unipolar type.
- For colour stimulation, the left eye is exposed to blue for 6 minutes in the initial stage and green for 6 minutes in the final stage. The right eye is exposed to the colour green for 6 minutes in the initial stage and blue for 6 minutes in the final stage as well.
- The total time duration of the procedure is 12 minutes. Experimental: Day 13 Day of no interventions. Experimental: Day 14 Day of no interventions.
Control: Day 1 - Day 14 The control group does not receive any intervention for 14 days.
Participants in the experimental group and control group are screened and tested on the first day and on day fourteen and on day 28th of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LI-TMS and AVS | Experimental | Device: Low Intensity Transcranial Magnetic Stimulation, Device: Auditory and visual stimulationParticipants receive low-intensity transcranial magnetic stimulation interventions with audio-visual stimulation for 14 days. On days 6, 7, 13, and 14 of the study, participants will not receive any interventions. Participants will be screened and tested on days 1 and 14 of treatment and two weeks after the end of the intervention. |
| Control | No intervention | –Participants receive no interventions for 14 days. Participants will be screened and tested on days 1, 14 and 28. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must be in good general health, as verified by reviewing their medical history and physical examination. They must not have any serious illnesses that could be a barrier to the research.
Key exclusion criteria (5 listed)
- somatic and neurological diseases in the exacerbation stage;
- presence of epileptic seizures on the EEG;
- cognitive disorders;
- presence of visual and hearing pathologies that prevent the sessions;
- women during pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Intensity Transcranial Magnetic StimulationAlso: LI-TMS* Magnetic stimulation frequency range: 0.1 - 700 Hz. * Amplitude of the magnetic field at a short distance from the magnetic coil: 1-5 milliTesla. * Emitter coil dimensions: ⌀28×26 mm. * Number of emitter coils: 32 coils. * Covering the entire scalp of a human head with 32 coil emitters. | Device | LI-TMS and AVS |
| Auditory and visual stimulation* Frequency range of light stimulation: 0.1 - 60 Hz. * Audio stimulation frequency range: 20 - 2000 Hz. * Sound level: 70 Decibel. * The wavelength range of visual stimulation: red - 620 - 760 nm; green - 510 - 550 nm; blue - 450 - 480 nm. * Illuminance: 300 - 350 lx. | Device | LI-TMS and AVS |
Primary outcome
Work Efficiency (WE)
Time frame: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Work Efficiency (WE) is a key parameter derived from the Schulte table test that quantifies the effectiveness of a participants performance during the test. It reflects the relationship between the number of correct responses and the time taken to complete the task. Calculation of Work Efficiency is calculated using the following formula: WE= T/N. Where: N = the number of tables completed by the participant. T = Time taken to complete the test (measured in seconds). This formula indicates that Work Efficiency increases with either a higher number of correct responses or a shorter completion time. Measurement Units Values in the range of 30 to 50 seconds are good result. Values above 90 seconds are a negative result. Better result of WE suggest better cognitive efficiency and processing speed, while worse result may indicate difficulties in attention or visual processing.
Warming-up Work Indicator (WU)
Time frame: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Warming-up Work Indicator (WU) indicates the amount of effort or cognitive load that an individual expends during the initial phase of the test. Calculation of WU The WU is typically calculated based on the time taken to complete the first task of the Schulte table test compared to the overall time taken for the entire test. The first tasks time is compared with the average WE time. A WU ratio close to 1 indicates the best possible preparation of the participant, whereas ratios above 1 indicate that more time needs to be taken as a warm-up before optimal performance. WU = T1 / WE Measurement Units A result less than 1.0 is an indicator of good Warming-up Work Indicator; accordingly, the higher 1.0 this indicator is, the more the subject needs preparation for the main job.
Psychological Stability (PS)
Time frame: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Psychological Stability (PS) is a parameter derived from the Schulte table test that assesses the ability to sustain the operational activity for a long time. It reflects how well a participant can manage distractions and maintain attention throughout the test. Calculation: PS =T(n-1) /WE. Measurement Units. Psychological Stability does not have a standardized unit of measurement; rather, it is often expressed as a score or index that can be compared across individuals or populations. Measurement Units The result indicator less than 1.0 indicates good Psychological Stability, accordingly, the higher this indicator is, the worse the Psychological Stability of the test subject to perform the tasks.
Attention switching time (t)
Time frame: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
The Test of Attention Switching Time Using Black-Red Table is a psychological assessment designed to measure the efficiency of attention switching in individuals. Attention switching time (t) refers to the duration it takes for an individual to shift their focus from one task or stimulus to another. It is a critical parameter in cognitive psychology, as it reflects the efficiency of an individuals cognitive processing and ability to manage attention in dynamic environments. Calculation: The difference between the time required to complete the last task and the sum of the time spent working on the first and the second task will be the time the subject spends switching attention from one activity to another. Measurement Units A shorter completion time of the Attentional Switching Time Test using the Black-Red Tables indicates better attentional switching ability.
Perceptual Accuracy (Tv)
Time frame: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
The Memorize and Place Shapes task is a cognitive assessment designed to evaluate spatial memory and perceptual accuracy. Perceptual Accuracy (Tv) refers to the precision with which an individual can recognize and reproduce shapes after they have been memorized. This parameter is crucial in understanding cognitive functions related to memory and visual processing. Calculation: The result is an overall calculation made from the complete number of dots correctly placed on all forms. Among others, the following is calculated: Perceptual accuracy: Tv = (∑ / n) * 100, where ∑ is the total number of correctly filled-in Remember and dot test forms and n is the number of dot cards viewed. Multiply the result of the division by 100 to obtain the perceptual accuracy in percent. Measurement Units The higher the Perceptual Accuracy (Tv) score on the Memorise and Place Shapes test, the better the participant\'s visual perception.
1 secondary outcome
EEG
Time frame: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: Yes. All individual patient data that underline results in a publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viktor Drobyshev, Dr. Med. Sc. principal investigator
Novosibirsk State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity Transcranial Magnetic Stimulation and Auditory and visual stimulation in people with Recovery Methods and Rehabilitation Program, run by Siberian Scientific Research and Test Center for Biomedical Engineering at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work Efficiency (WE) (time frame: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.