Chronic StroketACSNCT05947318
Effect of tACS on the Recovery of Motor Control of the Upper Limb and Cerebral Connectivity in Chronic Stroke Patients
A study testing transcranial alternating current stimulation 70 Hz, Training and transcranial alternating current stimulation 7 Hz in people with Chronic Stroke and Rehabilitation, run by Universidad Metropolitana de Ciencias de la Educacion at 1 site in Chile.
Trial summary
This project seeks to evaluate the effect of transcranial alternating current stimulation (tACS) on the recovery of motor control of the upper limb and associated neuronal synchrony during a 14-sessions (5-week) rehabilitation program for adult patients with diagnosis of stroke at chronic stage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Stroke, Rehabilitation
- What is being tested?
- transcranial alternating current stimulation 70 Hz, Training and transcranial alternating current stimulation 7 Hz
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteChile
- Study dates
- 2 May 2023to 7 Apr 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of unilateral stroke at chronic stage (6 months or more)
- Upper Extremity -Fugl Meyer > 10
- Wrist extensors strength of the paretic limb of 2 or more in the Medical Research Council (MRC) scale
- Active shoulder movement (flexion or abduction) of 30º or more
- Be able to follow the instructions necessary to achieve the training protocol
Who cannot join
- Have a cerebellar stroke or ataxia
- Have some medical condition contraindicated for tACS (epilepsy, pacemaker, prosthesis between others)
- Have post-stroke epilepsy
- Limited passive range of motion in the elbow (less than 45º in flexo-extension plane)
- Limited passive range of motion in the wrist (less than 40º in flexo-extension plane)
- Limited passive range of motion in the shoulder (less than 70º in flexo-extension plane)
- Have another neurological condition that leads to upper extremity sequelae
- Have a normal performance in the clinical test
Trial locations and contacts
1 site in 1 country.
Chile1 site
Centro de Habilidades Clínicas - Universidad Metropolitana de Ciencias de la Educación
Santiago, Santiago Metropolitan, 7780450
About this study
Official title: Effect of Transcranial Alternating Current Stimulation on the Recovery of Motor Control of the Upper Limb and Cerebral Connectivity in Chronic-stage Stroke Patients
This project seeks to evaluate the effect of transcranial alternating current stimulation (tACS) on the recovery of motor control of the upper limb and associated neuronal synchrony during a 14-sessions (5-week) rehabilitation program for adult patients with diagnosis of stroke at chronic stage. Specifically, the stimulation on Gamma ranges, because the evidence available so far allows us to propose that the tACS in the Gamma range (around 70 Hz) facilitates motor execution.
For this purpose, the experimental approach involves active (70 Hz in Gamma rhythm and 7 Hz, Theta rhythm) and sham tACS together with an analytical and integrated motor training with a double-blind and randomized design.
Read more
Our hypothesis is that Gamma frequency tACS restores neuronal synchrony in Beta range, which enhances the upper limb motor recovery associated with a training program.
Using specific motor control parameters, clinical scales and electroencephalography, the immediate and long-term (3 months after finished the training) behavioral and neurophysiological effect of this new neurostimulation paradigm (tACS plus training) for motor rehabilitation of stroke will be established.
Read the detailed description
This project seeks to evaluate the effect of transcranial alternating current stimulation (tACS) on the recovery of motor control of the upper limb and associated neuronal synchrony during a 14 sessions (5 week) rehabilitation program for adult patients with diagnosis of stroke at chronic stage. Specifically, the stimulation on Gamma ranges, because the evidence available so far allows us to propose that the tACS in the Gamma range (around 70 Hz) facilitates motor execution. For this purpose, the experimental approach involves active (70 Hz in Gamma rhythm and 7 Hz, Theta rhythm) and sham tACS together with an analytical and integrated motor training with a double-blind and randomized design.
Our hypothesis is that Gamma frequency tACS restores neuronal synchrony in Beta range, which enhances the upper limb motor recovery associated with a training program.
The general objective is to assess the effects of a combined program of tACS and upper limb training on motor performance and brain connectivity in chronic-stage stroke patients.
The specifics objectives to accomplish this are (1) Implement a system for simultaneous measurement of motor activity and EEG under tACS, considering possible postural alterations in stroke patients. (2) Evaluate the upper limb motor control and neuronal synchrony associated with motor performance during the execution of a combined stimulation and training program. Training will include analytical and functional tasks to optimize the performance in function and activity ICF level. tACS will be applied only during analytical task. (3) Analyze the changes in motor performance and neuronal synchrony for the experimental groups.
Using specific motor control parameters (kinetic and kinematic control), clinical scales and electroencephalography, the immediate and long-term (3 months after finished the training) behavioral and neurophysiological effect of this new neurostimulation paradigm (tACS plus training) for motor rehabilitation of stroke will be established.
By means of analysis of variance, clustering comparisons and linear regressions, it will be established the effect of tACS on neuronal synchrony and the parallel motor activity, as well as their underlying relationship.
We will use the REDCap platform to register all the clinical data given by the medical record and clinical assessments.
The recruitment will be made at the Clinical Center of Metropolitan University of Educational Sciences and in the Primary Care Centers that are near to the University. The sample size is 45 chronic stage stroke survivors. The sample size calculation used the data available in the study for the difference in Fugl-Meyer score between the bihemispheric and sham transcranial Direct Current Stimulation groups after the intervention (in the study of Alisar et al, 2020), considering an effect size of 1.4, a p-value of 0.05 and a power (1- beta) of 0.9, which yielded a sample size of 12 subjects per group. Now, also considering an attrition percentage of 20% and an equivalence in the size of the 3 study groups, the final sample size is 15 people per group (45 people in total).
To answer the study hypothesis, two variables will be examined as primary results:
- Behavioral level, it will be the score on the Fugl-Meyer scale (upper extremity section). This scale has been widely used in the field of neurorehabilitation to assess motor impairments (ICF function level).
- Neurophysiological level, the primary outcome will be the change in spectral power in the Beta band (13-30Hz) associated with motor performance in kinetic and kinematic tasks. Signal processing will follow a cluster approach using the Fieldtrip toolbox in Matlab software (R2016B).
Both variables will be subjected to a two-factor analysis of variance (experimental group factor (3 levels, tACS-70Hz, 7Hz and simulated) and time factor (4 levels referred to the measurement times)). Depending on the result, it will apply a post-hoc test (bonferroni) to study differences between levels and interactions. The association between the variables will be inspected through regression models. The level of significance will have a p-value of 0.05. The statistical analysis will be implemented in the R language and the Rstudio software. Complementary to the primary results, and in order to broaden the description of the study phenomenon, the scores of the clinical scales already described will be analyzed, as well as kinetic (absolute force, speed of force change) and kinematic variables (direction error, maximum speed) of the analytical and combined tasks. In addition, the long-scale synchrony will be described by means of connectivity variables between the electrodes already identified (phase locking value and weighted phase lag index).
- Conditions
- Chronic Stroke, Rehabilitation
- Being tested
- transcranial alternating current stimulation 70 Hz, Training, transcranial alternating current stimulation 7 Hz, transcranial alternating current stimulation Sham
- Keywords
- transcranial alternating current stimulation, motor recovery, stroke rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial alternating current stimulation 70 HzDevice
Transcranial alternating current stimulation in the head above the motor cortex area of one side of the brain, according to the hemiparesis side.
Electrodes with 3.14 cm2 of stimulation area will be used, therefore, the initial current intensity will be 0.21 mA, with a current density of 0.07 mA / cm2. The current intensity will be adjusted to the tactile sensory threshold and phosphenes of each patient, with in order to reduce such sensory effects, but considering that the decrease in current will not be greater than 10% of the initial intensity, in order to obtain a comparable configuration between subjects.
The frequency stimulation will be 70 Hz
TrainingBehavioural
Training of the upper limb with specific kinematic and kinetic tasks plus functional training
transcranial alternating current stimulation 7 HzDevice
Transcranial alternating current stimulation in the head above the motor cortex area of one side of the brain, according to the hemiparesis side.
Electrodes with 3.14 cm2 of stimulation area will be used, therefore, the initial current intensity will be 0.21 mA, with a current density of 0.07 mA / cm2. The current intensity will be adjusted to the tactile sensory threshold and phosphenes of each patient, with in order to reduce such sensory effects, but considering that the decrease in current will not be greater than 10% of the initial intensity, in order to obtain a comparable configuration between subjects.
The frequency stimulation will be 7 Hz
transcranial alternating current stimulation ShamDevice
Transcranial alternating current stimulation in the head above the motor cortex area of one side of the brain, according to the hemiparesis side.
Electrodes with 3.14 cm2 of stimulation area will be used, therefore, the initial current intensity will be 0.21 mA, with a current density of 0.07 mA / cm2. The current intensity will be adjusted to the tactile sensory threshold and phosphenes of each patient, with in order to reduce such sensory effects, but considering that the decrease in current will not be greater than 10% of the initial intensity, in order to obtain a comparable configuration between subjects.
The stimulation will be turn on for 30 seconds (at 70 Hz)
| Study group | Role | What they receive |
|---|---|---|
| tACS - 70 Hz group | Experimental | The group will receive the training program plus 20 minutes of tACS at 70 Hz in the C3 or C4 electrode position (depending of the hemiparetic arm) during a specific kinetic and kinematic tasks in every training session. Receives: Device: transcranial alternating current stimulation 70 Hz; Behavioral: Training |
| tACS - 7 Hz group | Active comparator | The group will receive the training program plus 20 minutes of tACS at 7 Hz in the C3 or C4 electrode position (depending of the hemiparetic arm) during a specific kinetic and kinematic tasks in every training session. Receives: Behavioral: Training; Device: transcranial alternating current stimulation 7 Hz |
| tACS - sham group | Sham comparator | The group will receive the training program plus 30 seconds of tACS at 70 Hz in the C3 or C4 electrode position (depending of the hemiparetic arm) in every training session. Receives: Behavioral: Training; Device: transcranial alternating current stimulation Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impairment Measure pre-intervention: Upper Extremity Fugl Meyer
Scale use to assess motor impairments (ICF function level), and adequately reflects the analytical motor control of force and direction of movement. The scale has a maximum of 66 points, which indicates a normal performance. Lower scores indicate worse performance.
Measured: week 0
Change of Impairment Measure post-intervention: Upper Extremity Fugl Meyer
Scale use to assess motor impairments (ICF function level), and adequately reflects the analytical motor control of force and direction of movement. The scale has a maximum of 66 points, which indicates a normal performance. Lower scores indicate worse performance.
Measured: week 5 or 6 (end of the training program)
Change of Impairment Measure follow up: Upper Extremity Fugl Meyer
Scale use to assess motor impairments (ICF function level), and adequately reflects the analytical motor control of force and direction of movement. The scale has a maximum of 66 points, which indicates a normal performance. Lower scores indicate worse performance.
Measured: week 12
EEG spectral power in Beta band pre-intervention
Change in spectral power in the Beta band (13-30Hz) associated with motor performance in kinetic and kinematic tasks
Measured: week 0
Change in EEG spectral power in Beta band post-intervention
Change in spectral power in the Beta band (13-30Hz) associated with motor performance in kinetic and kinematic tasks
Measured: week 5 or 6 (end of the training program)
Change in EEG spectral power in Beta band follow up
Change in spectral power in the Beta band (13-30Hz) associated with motor performance in kinetic and kinematic tasks
Measured: week 12
Secondary outcomes (9)
Activity Measure: Action Research Arm Test
Action Research Arm Test will be used to evaluate de ICF activity level. The maximum score is 57, which indicate a normal perfomance. Lower scores indicate worse performance.
Measured: week 0, week 5 or 6 (end of the training program) and week 12
Change in Activity Measure post-intervention: Action Research Arm Test
Action Research Arm Test will be used to evaluate de ICF activity level. The maximum score is 57, which indicate a normal perfomance. Lower scores indicate worse performance.
Measured: week 5 or 6 (end of the training program)
Change in Activity Measure follow up: Action Research Arm Test
Action Research Arm Test will be used to evaluate de ICF activity level. The maximum score is 57, which indicate a normal perfomance. Lower scores indicate worse performance.
Measured: week 12
Performance measure in the trained kinetic task (behavioral parameter)
The change that we observed in the kinetic task in the protocol training. This outcome is a behavioral parameter that measures the change in the task that is trained in the training protocol. It is a measure of how the participants performed the kinetic task
Measured: week 0, week 5 or 6 (end of the training program) and week 12
Change in the performance measure in the trained kinetic task post-intertenvion (behavioral parameter)
The change that we observed in the kinetic task in the protocol training. This outcome is a behavioral parameter that measures the change in the task that is trained in the training protocol. It is a measure of the change in the performance in the kinetic task at the beginning of the training protocol and at the end.
Measured: week 5 or 6 (end of the training program)
Change in the performance measure in the trained kinetic task at follow up (behavioral parameter)
The change that we observed in the kinetic task in the protocol training. This outcome is a behavioral parameter that measures the change in the task that is trained in the training protocol. It is a measure of the change in the performance in the kinetic task at the beginning of the training protocol and at the 12 week follow up.
Measured: week 12
Performance measure in trained kinematic task (behavioral parameter)
The change that we observed in the kinematic task in the protocol training. This outcome is a behavioral parameter that measures the change in the task that is trained in the training protocol. It is a measure of how the participants performed the kinematic task
Measured: week 0, week 5 or 6 (end of the training program) and week 12
Change in the performance measure in the trained kinematic task post-intervention (behavioral parameter)
The change that we observed in the kinematic task in the protocol training. This outcome is a behavioral parameter that measure the change in the task that is trained in the training protocol. It is a measure of the change in the performance in the kinematic task at the beginning of the training protocol and at the end.
Measured: week 5 or 6 (end of the training program)
Change in performance measure in the trained kinematic task at follow up (behavioral parameter)
The change that we observed in the kinematic task in the protocol training. This outcome is a behavioral parameter that measure the change in the task that is trained in the training protocol. It is a measure of the change in the performance in the kinematic task at the beginning of the training protocol and at the end.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start2 May 2023
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Three experimental groups: 1. tACS-70 Hz group 2. tACS-7Hz group 3. tACS-sham group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Metropolitana de Ciencias de la Educacion
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Jose Mariman Rivero, Universidad Metropolitana de Ciencias de la Educacion
- Investigators
- Juan J Mariman, Ph.D, Principal investigator, Universidad Metropolitana de Ciencias de la Educacion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947318
- Sponsor's protocol ID
- FONDECYT N° 11221226
- Acronym
- tACS
- Status last verified
- Apr 2025
- First submitted
- 12 Jun 2023
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For now, we have no plans of sharing individual participant data.
Publications
Alisar DC, Ozen S, Sozay S. Effects of Bihemispheric Transcranial Direct Current Stimulation on Upper Extremity Function in Stroke Patients: A randomized Double-Blind Sham-Controlled Study. J Stroke Cerebrovasc Dis. 2020 Jan;29(1):104454. doi: 10.1016/j.jstrokecerebrovasdis.2019.104454. Epub 2019 Nov 4.
PubMed 31699572
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Alternating Current Stimulation on the Recovery of Motor Control of the Upper Limb and Cerebral Connectivity in Chronic-stage Stroke Patients
- ClinicalTrials.gov ID
- NCT05947318
- Acronym / sponsor ID
- tACS / FONDECYT N° 11221226
- Conditions
- Chronic Stroke, Rehabilitation
- Keywords
- transcranial alternating current stimulation, motor recovery, stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Universidad Metropolitana de Ciencias de la EducacionUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 17 Jul 2023 (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 project seeks to evaluate the effect of transcranial alternating current stimulation (tACS) on the recovery of motor control of the upper limb and associated neuronal synchrony during a 14-sessions (5-week) rehabilitation program for adult patients with diagnosis of stroke at chronic stage. Specifically, the stimulation on Gamma ranges, because the evidence available so far allows us to propose that the tACS in the Gamma range (around 70 Hz) facilitates motor execution.
For this purpose, the experimental approach involves active (70 Hz in Gamma rhythm and 7 Hz, Theta rhythm) and sham tACS together with an analytical and integrated motor training with a double-blind and randomized design.
Our hypothesis is that Gamma frequency tACS restores neuronal synchrony in Beta range, which enhances the upper limb motor recovery associated with a training program.
Using specific motor control parameters, clinical scales and electroencephalography, the immediate and long-term (3 months after finished the training) behavioral and neurophysiological effect of this new neurostimulation paradigm (tACS plus training) for motor rehabilitation of stroke will be established.
Detailed description
This project seeks to evaluate the effect of transcranial alternating current stimulation (tACS) on the recovery of motor control of the upper limb and associated neuronal synchrony during a 14 sessions (5 week) rehabilitation program for adult patients with diagnosis of stroke at chronic stage. Specifically, the stimulation on Gamma ranges, because the evidence available so far allows us to propose that the tACS in the Gamma range (around 70 Hz) facilitates motor execution. For this purpose, the experimental approach involves active (70 Hz in Gamma rhythm and 7 Hz, Theta rhythm) and sham tACS together with an analytical and integrated motor training with a double-blind and randomized design.
Our hypothesis is that Gamma frequency tACS restores neuronal synchrony in Beta range, which enhances the upper limb motor recovery associated with a training program.
The general objective is to assess the effects of a combined program of tACS and upper limb training on motor performance and brain connectivity in chronic-stage stroke patients.
The specifics objectives to accomplish this are (1) Implement a system for simultaneous measurement of motor activity and EEG under tACS, considering possible postural alterations in stroke patients. (2) Evaluate the upper limb motor control and neuronal synchrony associated with motor performance during the execution of a combined stimulation and training program. Training will include analytical and functional tasks to optimize the performance in function and activity ICF level. tACS will be applied only during analytical task. (3) Analyze the changes in motor performance and neuronal synchrony for the experimental groups.
Using specific motor control parameters (kinetic and kinematic control), clinical scales and electroencephalography, the immediate and long-term (3 months after finished the training) behavioral and neurophysiological effect of this new neurostimulation paradigm (tACS plus training) for motor rehabilitation of stroke will be established.
By means of analysis of variance, clustering comparisons and linear regressions, it will be established the effect of tACS on neuronal synchrony and the parallel motor activity, as well as their underlying relationship.
We will use the REDCap platform to register all the clinical data given by the medical record and clinical assessments.
The recruitment will be made at the Clinical Center of Metropolitan University of Educational Sciences and in the Primary Care Centers that are near to the University. The sample size is 45 chronic stage stroke survivors. The sample size calculation used the data available in the study for the difference in Fugl-Meyer score between the bihemispheric and sham transcranial Direct Current Stimulation groups after the intervention (in the study of Alisar et al, 2020), considering an effect size of 1.4, a p-value of 0.05 and a power (1- beta) of 0.9, which yielded a sample size of 12 subjects per group. Now, also considering an attrition percentage of 20% and an equivalence in the size of the 3 study groups, the final sample size is 15 people per group (45 people in total).
To answer the study hypothesis, two variables will be examined as primary results:
- Behavioral level, it will be the score on the Fugl-Meyer scale (upper extremity section). This scale has been widely used in the field of neurorehabilitation to assess motor impairments (ICF function level).
- Neurophysiological level, the primary outcome will be the change in spectral power in the Beta band (13-30Hz) associated with motor performance in kinetic and kinematic tasks. Signal processing will follow a cluster approach using the Fieldtrip toolbox in Matlab software (R2016B).
Both variables will be subjected to a two-factor analysis of variance (experimental group factor (3 levels, tACS-70Hz, 7Hz and simulated) and time factor (4 levels referred to the measurement times)). Depending on the result, it will apply a post-hoc test (bonferroni) to study differences between levels and interactions. The association between the variables will be inspected through regression models. The level of significance will have a p-value of 0.05. The statistical analysis will be implemented in the R language and the Rstudio software. Complementary to the primary results, and in order to broaden the description of the study phenomenon, the scores of the clinical scales already described will be analyzed, as well as kinetic (absolute force, speed of force change) and kinematic variables (direction error, maximum speed) of the analytical and combined tasks. In addition, the long-scale synchrony will be described by means of connectivity variables between the electrodes already identified (phase locking value and weighted phase lag index).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Three experimental groups: 1. tACS-70 Hz group 2. tACS-7Hz group 3. tACS-sham group
| Arm | Type | Receives |
|---|---|---|
| tACS - 70 Hz group | Experimental | Device: transcranial alternating current stimulation 70 Hz, Behavioral: TrainingThe group will receive the training program plus 20 minutes of tACS at 70 Hz in the C3 or C4 electrode position (depending of the hemiparetic arm) during a specific kinetic and kinematic tasks in every training session. |
| tACS - 7 Hz group | Active comparator | Behavioral: Training, Device: transcranial alternating current stimulation 7 HzThe group will receive the training program plus 20 minutes of tACS at 7 Hz in the C3 or C4 electrode position (depending of the hemiparetic arm) during a specific kinetic and kinematic tasks in every training session. |
| tACS - sham group | Sham comparator | Behavioral: Training, Device: transcranial alternating current stimulation ShamThe group will receive the training program plus 30 seconds of tACS at 70 Hz in the C3 or C4 electrode position (depending of the hemiparetic arm) in every training session. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of unilateral stroke at chronic stage (6 months or more)
- Upper Extremity -Fugl Meyer > 10
- Wrist extensors strength of the paretic limb of 2 or more in the Medical Research Council (MRC) scale
- Active shoulder movement (flexion or abduction) of 30º or more
- Be able to follow the instructions necessary to achieve the training protocol
Key exclusion criteria (8 listed)
- Have a cerebellar stroke or ataxia
- Have some medical condition contraindicated for tACS (epilepsy, pacemaker, prosthesis between others)
- Have post-stroke epilepsy
- Limited passive range of motion in the elbow (less than 45º in flexo-extension plane)
- Limited passive range of motion in the wrist (less than 40º in flexo-extension plane)
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 |
|---|---|---|
| transcranial alternating current stimulation 70 HzTranscranial alternating current stimulation in the head above the motor cortex area of one side of the brain, according to the hemiparesis side. Electrodes with 3.14 cm2 of stimulation area will be used, therefore, the initial current intensity will be 0.21 mA, with a current density of 0.07 mA / cm2. The current intensity will be adjusted to the tactile sensory threshold and phosphenes of each patient, with in order to reduce such sensory effects, but considering that the decrease in current will not be greater than 10% of the initial intensity, in order to obtain a comparable configuration between subjects. The frequency stimulation will be 70 Hz | Device | tACS - 70 Hz group |
| TrainingTraining of the upper limb with specific kinematic and kinetic tasks plus functional training | Behavioural | tACS - 7 Hz group, tACS - 70 Hz group, tACS - sham group |
| transcranial alternating current stimulation 7 HzTranscranial alternating current stimulation in the head above the motor cortex area of one side of the brain, according to the hemiparesis side. Electrodes with 3.14 cm2 of stimulation area will be used, therefore, the initial current intensity will be 0.21 mA, with a current density of 0.07 mA / cm2. The current intensity will be adjusted to the tactile sensory threshold and phosphenes of each patient, with in order to reduce such sensory effects, but considering that the decrease in current will not be greater than 10% of the initial intensity, in order to obtain a comparable configuration between subjects. The frequency stimulation will be 7 Hz | Device | tACS - 7 Hz group |
| transcranial alternating current stimulation ShamTranscranial alternating current stimulation in the head above the motor cortex area of one side of the brain, according to the hemiparesis side. Electrodes with 3.14 cm2 of stimulation area will be used, therefore, the initial current intensity will be 0.21 mA, with a current density of 0.07 mA / cm2. The current intensity will be adjusted to the tactile sensory threshold and phosphenes of each patient, with in order to reduce such sensory effects, but considering that the decrease in current will not be greater than 10% of the initial intensity, in order to obtain a comparable configuration between subjects. The stimulation will be turn on for 30 seconds (at 70 Hz) | Device | tACS - sham group |
Primary outcome
Impairment Measure pre-intervention: Upper Extremity Fugl Meyer
Time frame: week 0
Scale use to assess motor impairments (ICF function level), and adequately reflects the analytical motor control of force and direction of movement. The scale has a maximum of 66 points, which indicates a normal performance. Lower scores indicate worse performance.
Change of Impairment Measure post-intervention: Upper Extremity Fugl Meyer
Time frame: week 5 or 6 (end of the training program)
Scale use to assess motor impairments (ICF function level), and adequately reflects the analytical motor control of force and direction of movement. The scale has a maximum of 66 points, which indicates a normal performance. Lower scores indicate worse performance.
Change of Impairment Measure follow up: Upper Extremity Fugl Meyer
Time frame: week 12
Scale use to assess motor impairments (ICF function level), and adequately reflects the analytical motor control of force and direction of movement. The scale has a maximum of 66 points, which indicates a normal performance. Lower scores indicate worse performance.
EEG spectral power in Beta band pre-intervention
Time frame: week 0
Change in spectral power in the Beta band (13-30Hz) associated with motor performance in kinetic and kinematic tasks
Change in EEG spectral power in Beta band post-intervention
Time frame: week 5 or 6 (end of the training program)
Change in spectral power in the Beta band (13-30Hz) associated with motor performance in kinetic and kinematic tasks
Change in EEG spectral power in Beta band follow up
Time frame: week 12
Change in spectral power in the Beta band (13-30Hz) associated with motor performance in kinetic and kinematic tasks
9 secondary outcomes
Activity Measure: Action Research Arm Test
Time frame: week 0, week 5 or 6 (end of the training program) and week 12
Change in Activity Measure post-intervention: Action Research Arm Test
Time frame: week 5 or 6 (end of the training program)
Change in Activity Measure follow up: Action Research Arm Test
Time frame: week 12
Performance measure in the trained kinetic task (behavioral parameter)
Time frame: week 0, week 5 or 6 (end of the training program) and week 12
Change in the performance measure in the trained kinetic task post-intertenvion (behavioral parameter)
Time frame: week 5 or 6 (end of the training program)
Change in the performance measure in the trained kinetic task at follow up (behavioral parameter)
Time frame: week 12
Performance measure in trained kinematic task (behavioral parameter)
Time frame: week 0, week 5 or 6 (end of the training program) and week 12
Change in the performance measure in the trained kinematic task post-intervention (behavioral parameter)
Time frame: week 5 or 6 (end of the training program)
Change in performance measure in the trained kinematic task at follow up (behavioral parameter)
Time frame: week 12
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 29 Apr 2025.
- Background: PubMed 31699572Alisar DC, Ozen S, Sozay S. Effects of Bihemispheric Transcranial Direct Current Stimulation on Upper Extremity Function in Stroke Patients: A randomized Double-Blind Sham-Controlled Study. J Stroke Cerebrovasc Dis. 2020 Jan;29(1):104454. doi: 10.1016/j.jstrokecerebrovasdis.2019.104454. Epub 2019 Nov 4.
- Individual participant dataSharing planned: No. For now, we have no plans of sharing individual participant data.
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Stroke, Ischemic, Chronic Stroke
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Not yet recruiting
Proof-of-concept for Use of Transcutaneous Spinal Stimulation (TSS) With the ExaStim® Stimulation System in Adults With Chronic Ischemic Stroke
Chronic Stroke, Ischemic Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
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.
Juan J Mariman, Ph.D principal investigator
Universidad Metropolitana de Ciencias de la Educacion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial alternating current stimulation 70 Hz, Training and transcranial alternating current stimulation 7 Hz in people with Chronic Stroke and Rehabilitation, run by Universidad Metropolitana de Ciencias de la Educacion at 1 site in Chile.
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 5 inclusion and 8 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 29 Apr 2025. 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 Chile. 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. Some participants in this study may receive a placebo. 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?
Impairment Measure pre-intervention: Upper Extremity Fugl Meyer (time frame: week 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05947318, which also lists 1 linked publication.
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 29 Apr 2025.