StrokeNCT06386627
Study of Neurophysiological Markers of Motor Recovery in Post-stroke Patients.
An observational study of Stroke, run by Skolkovo Institute of Science and Technology at 1 site in Russia.
Trial summary
The aim of the study was to explore potential pathways for recovery and adaptation of neural pathways after stroke by examining electrical activity of the brain cortex and cortico-spinal excitability using transcranial magnetic stimulation in people with motor impairment after stroke. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Stimulus response task and Transcranial magnetic stimulation
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2023to 15 Mar 2024
- Phase
- Observational
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing rehabilitation at the Federal center of brain research and neurotechnologies, FMBA, Moscow, Russia.
Who may be able to join
- 1. Availability of signed written informed consent. 3. Absence of somatic and psychiatric diseases (more details in the exclusion criteria) 4. Ability and willingness to comply with the requirements of this protocol.
- Signed written informed consent.
- People after the first acute cerebrovascular accident (CVA), early or late rehabilitation period.
- The level of severity of paresis of the upper limb from 3 points to 0 (according to a 6-point neurological scale)
- The minimum visual acuity is not lower than 0.2 on the Sivtsev scale.
- The ability and willingness of the patient to comply with the requirements of this protocol.
- Expressed patient motivation for rehabilitation.
Who cannot join
- The presence of superficial injury of head (S00-S09 International Classification of Diseases 10 (ICD-10).
- The presence of mental, behavioural disorders (F00-F99 ICD-10).
- Drug addiction in the past or at the moment.
- The presence of diseases of the nervous system (G00-G99 ICD-10).
- . History of intracranial injury (S06 ICD-10) or stroke (I64 ICD-10).
- The presence of somatoform disorders (F45 ICD-10).
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- Any conditions that, in the opinion of the Investigator, meet the exclusion criteria
- Presence of electrical and/or metallic implants or stimulants in the body (eg, implanted deep brain stimulation devices, pacemakers, hearing aids and cochlear implants, intracranial metal implants).
- Pregnancy
- The presence of malignant neoplasms (C00-C97 ICD-10).
- For stroke patients:
- Severe cognitive impairment (<10 points according to the Montreal Cognitive Assessment Scale).
- Hamilton score above 18 points.
- The score on the Rankin scale is above 4 points.
- Associated neurological disorders that cause decreased muscle strength or increased muscle tone in the upper limbs (eg, cerebral palsy, brain damage from trauma) or stiffness (eg, Parkinson's disease, contracture).
- Late stages of arthritis or clinically significant limitation of passive range of motion in any of the joints studied in the study due to other reasons.
- The absence of a part of the upper limb due to amputation caused by various reasons.
- Any medical condition, including mental illness or epilepsy, that may affect the interpretation of study results, study conduct, or patient safety.
- Alcohol abuse, medical marijuana use, or recreational drug use in the 12 months prior to Visit 1.
- Use of experimental drugs or medical devices within 30 days prior to Visit 1.
- Lack of ability to follow study procedures, in the opinion of the investigator.
- The severity of the patient's condition according to the neurological or somatic status, which does not allow full rehabilitation.
- Severe visual disturbances, minimal visual acuity less than 0.2 Sivtsev visual acuity table.
- Unstable angina and/or heart attack within the previous month
- Repeated stroke.
- Severe unilateral spatial neglect.
- Uncontrolled arterial hypertension
- Ataxia
- All forms of epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Mechanisms of Visual-motor Transformation to Search for Neurophysiological Markers of Changes in the Functions of Cortical Motor Circuits in Patients With Neurological Disorders, and Development of Technologies for Their Rehabilitation.
The aim of the study was to explore potential pathways for recovery and adaptation of neural pathways after stroke by examining electrical activity of the brain cortex and cortico-spinal excitability using transcranial magnetic stimulation in people with motor impairment after stroke. Participants in the study performed a simple stimulus-response task with a healthy and a paralysed limb several times at different stages of basic rehabilitation. To compare the data, a group of healthy volunteers took part in a similar experiment. Investigators recorded cortical activity using electroencephalography and muscle activity using electromyography. After the stimulus-response task, investigators also carried out a study using transcranial magnetic stimulation to assess the integrity of corticospinal connections.
Read the detailed description
The study involved 40 participants, half of whom had suffered a stroke with hemiparesis and the other half a control group of healthy volunteers. During the experimental session, the participants have to perform a motor task involving reaction speed. A box with two buttons (right and left) is placed in front of the participant. The participant's hands are placed in the box under the buttons. The experimental task is to press one of the two buttons by extending the fingers in response to a visual stimulus - lamps above the buttons. If the degree of damage to the motor function of one of the participant's limbs does not allow a full button to be pressed, the participants is asked to form an intention for this movement and try to perform it. At the same time, one of the buttons has been designated as a 'target' for the patient, and it is in response to its highlighting that a movement is to be performed. The second button is 'non-target'. Its highlighting should be ignored. Throughout the session, each of the buttons was designated as a target several times.
Throughout the session, the electroencephalogram (EEG) signal was recorded in 17 electrodes placed on the scalp according to the international "10-10" registration system. The recording was performed with a medical electroencephalograph NVX-36 ("Medical Computer Systems", Zelenograd, Russia). Electromyographic (EMG) activity of the flexor digitorum superficialis muscles of both hands was also recorded using surface electrodes. The EMG is recorded with the same amplifier as the EEG signal (NVX-36). The participant takes part in the test within 2 weeks. There were two sessions (at the beginning of rehabilitation and before discharge). Each session lasts a maximum of one hour.
Before the study, the participants' motor activity was tested using the Action Research Arm Test (ARAT). The EEG data were analysed for markers such as movement-related potentials and movement-related desynchronisation of alpha and beta rhythms. Some participants were also invited to take part in an additional study using transcranial magnetic stimulation to assess the integrity of corticospinal connections.
- Conditions
- Stroke
- Being tested
- Stimulus response task, Transcranial magnetic stimulation
- Keywords
- stroke, hemiparesis, motor cortex, restoration of motor functions, upper limbs
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulus response taskDiagnostic test
Participants were tasked with performing a finger extension exercise that required pressing buttons in response to visual stimuli. In cases where physical movement was not possible, participants were instructed to imagine performing the task while focusing on their fingers.
Transcranial magnetic stimulationDiagnostic test
Transcranial magnetic stimulation to assess the integrity of corticospinal connections
| Study group | Role | What they receive |
|---|---|---|
| Post-stroke persons | Not described Receives: Diagnostic Test: Stimulus response task; Diagnostic Test: Transcranial magnetic stimulation | |
| Healthy volunteers | Not described Receives: Diagnostic Test: Stimulus response task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atypical shape of lateralized readiness potential
Shape and scalp-distribution of the lateralized pre-motor cortical potentials in post-stroke participants demonstrated bilateral involvement of primary motor cortex, indicating role of healthy hemisphere in the control of impaired limb movements.
Measured: 15 days
Secondary outcomes (1)
Absent of ipsilateral muscles contraction in response to primary motor cortex stimulation in both hemispheres
Transcranial magnetic stimulation did not show increased activity of ipsilateral projections. from intact hemisphere motor cortex to paralyzed limb
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Jul 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skolkovo Institute of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Federal center of brain research and neurotechnologies, FMBA, Moscow, Russia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386627
- Sponsor's protocol ID
- Skoltech-CNBR3
- Other IDs
- 21-75-30024
- Status last verified
- May 2024
- First submitted
- 23 Apr 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Mechanisms of Visual-motor Transformation to Search for Neurophysiological Markers of Changes in the Functions of Cortical Motor Circuits in Patients With Neurological Disorders, and Development of Technologies for Their Rehabilitation.
- ClinicalTrials.gov ID
- NCT06386627
- Acronym / sponsor ID
- Skoltech-CNBR3
- Conditions
- Stroke
- Keywords
- stroke, hemiparesis, motor cortex, restoration of motor functions, upper limbs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Skolkovo Institute of Science and TechnologyUniversity, hospital or other
- Collaborators
- Federal center of brain research and neurotechnologies, FMBA, Moscow, Russia
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 26 Apr 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.
The aim of the study was to explore potential pathways for recovery and adaptation of neural pathways after stroke by examining electrical activity of the brain cortex and cortico-spinal excitability using transcranial magnetic stimulation in people with motor impairment after stroke. Participants in the study performed a simple stimulus-response task with a healthy and a paralysed limb several times at different stages of basic rehabilitation. To compare the data, a group of healthy volunteers took part in a similar experiment. Investigators recorded cortical activity using electroencephalography and muscle activity using electromyography. After the stimulus-response task, investigators also carried out a study using transcranial magnetic stimulation to assess the integrity of corticospinal connections.
Detailed description
The study involved 40 participants, half of whom had suffered a stroke with hemiparesis and the other half a control group of healthy volunteers. During the experimental session, the participants have to perform a motor task involving reaction speed. A box with two buttons (right and left) is placed in front of the participant. The participant's hands are placed in the box under the buttons. The experimental task is to press one of the two buttons by extending the fingers in response to a visual stimulus - lamps above the buttons. If the degree of damage to the motor function of one of the participant's limbs does not allow a full button to be pressed, the participants is asked to form an intention for this movement and try to perform it. At the same time, one of the buttons has been designated as a 'target' for the patient, and it is in response to its highlighting that a movement is to be performed. The second button is 'non-target'. Its highlighting should be ignored. Throughout the session, each of the buttons was designated as a target several times.
Throughout the session, the electroencephalogram (EEG) signal was recorded in 17 electrodes placed on the scalp according to the international "10-10" registration system. The recording was performed with a medical electroencephalograph NVX-36 ("Medical Computer Systems", Zelenograd, Russia). Electromyographic (EMG) activity of the flexor digitorum superficialis muscles of both hands was also recorded using surface electrodes. The EMG is recorded with the same amplifier as the EEG signal (NVX-36). The participant takes part in the test within 2 weeks. There were two sessions (at the beginning of rehabilitation and before discharge). Each session lasts a maximum of one hour.
Before the study, the participants' motor activity was tested using the Action Research Arm Test (ARAT). The EEG data were analysed for markers such as movement-related potentials and movement-related desynchronisation of alpha and beta rhythms. Some participants were also invited to take part in an additional study using transcranial magnetic stimulation to assess the integrity of corticospinal connections.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-stroke persons | – | Diagnostic Test: Stimulus response task, Diagnostic Test: Transcranial magnetic stimulation |
| Healthy volunteers | – | Diagnostic Test: Stimulus response task |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing rehabilitation at the Federal center of brain research and neurotechnologies, FMBA, Moscow, Russia.
Key inclusion criteria (7 listed)
- 1. Availability of signed written informed consent. 3. Absence of somatic and psychiatric diseases (more details in the exclusion criteria) 4. Ability and willingness to comply with the requirements of this protocol.
- Signed written informed consent.
- People after the first acute cerebrovascular accident (CVA), early or late rehabilitation period.
- The level of severity of paresis of the upper limb from 3 points to 0 (according to a 6-point neurological scale)
- The minimum visual acuity is not lower than 0.2 on the Sivtsev scale.
Key exclusion criteria (29 listed)
- The presence of superficial injury of head (S00-S09 International Classification of Diseases 10 (ICD-10).
- The presence of mental, behavioural disorders (F00-F99 ICD-10).
- Drug addiction in the past or at the moment.
- The presence of diseases of the nervous system (G00-G99 ICD-10).
- . History of intracranial injury (S06 ICD-10) or stroke (I64 ICD-10).
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 |
|---|---|---|
| Stimulus response taskParticipants were tasked with performing a finger extension exercise that required pressing buttons in response to visual stimuli. In cases where physical movement was not possible, participants were instructed to imagine performing the task while focusing on their fingers. | Diagnostic test | Healthy volunteers, Post-stroke persons |
| Transcranial magnetic stimulationTranscranial magnetic stimulation to assess the integrity of corticospinal connections | Diagnostic test | Post-stroke persons |
Primary outcome
Atypical shape of lateralized readiness potential
Time frame: 15 days
Shape and scalp-distribution of the lateralized pre-motor cortical potentials in post-stroke participants demonstrated bilateral involvement of primary motor cortex, indicating role of healthy hemisphere in the control of impaired limb movements.
1 secondary outcome
Absent of ipsilateral muscles contraction in response to primary motor cortex stimulation in both hemispheres
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Skolkovo Institute of Science and Technology 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 7 inclusion and 29 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: finished, as of the sponsor's last update on 23 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Atypical shape of lateralized readiness potential (time frame: 15 days). 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 23 May 2024.