Hemorrhagic StrokeNCT07236216
Effects of tES Combined With CMDT Gait Training on Cognition, Cortical Activity, Spinal Motoneuron Excitability and Motor Performance in Stroke Individuals
A study testing High-definition transcranial direct current stimulation (Active), High-definition transcranial alternating stimulation (Active) and Cognitive-motor dual task gait training in people with Hemorrhagic Stroke and Ischemic Stroke, run by Mahidol University at 1 site in Thailand.
Trial summary
The present study will use transcranial electrical stimulation (tES) which are transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) combined with conventional physical therapy and cognitive-motor dual task gait training in sub-acute (at least 2 weeks after stroke… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhagic Stroke, Ischemic Stroke, Subacute Stroke
- What is being tested?
- High-definition transcranial direct current stimulation (Active), High-definition transcranial alternating stimulation (Active) and Cognitive-motor dual task gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 20 Dec 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Unilateral stroke individuals aged 18-80 years.
- A first-ever stroke.
- Stroke onset from at least 2 weeks-5 years.
- Able to walk independently with or without gait aids (modified Rankin scale (mRS) 1-3)
- Montreal cognitive Assessment-Thai version (MoCA-T) greater than or equal to 20 scores.
- Ability to read, communicate, follow and understand instructions.
Who cannot join
- Presence of any psychological or neurological antecedent, unstable medical conditions or condition that may increase risk of stimulation such as epilepsy, seizure, and history of brain injury
- Having unstable cardiovascular disease or respiratory disease, and uncontrolled chronic disease such as diabetes mellitus (DM), hypertension (HT) and chronic kidney disease (CKD)
- Receiving other non-invasive brain stimulation or additional intervention such as TMS, PMS or acupuncture
- Presence of metal implantation, intracranial shunt, cochlear implantation, or cardiac pacemakers.
- Presence of an opened wound, infectious wound around scalp or craniectomy with unreplaced bone flap
- Moderate pain (numeric pain rating score > 4/10) in any joint of the upper or lower limb, whether paretic or non-paretic
- Presence of color blindness
- Presence of any substance use including cannabis and kratom
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Mahidol University
Nakhon Pathom, 73170
Wanalee Klomjai, PhD, +6624415450 ext. 20216, wanalee.klo@mahidol.edu
Wanalee Klomjai, PhD
About this study
Official title: Effects of Transcranial Electrical Stimulation (tES) Combined With Cognitive-motor Dual-task Gait Training on Cortical Activity, Spinal Motoneuron Excitability, Cognition and Motor Performance in Stroke Individuals
The present study will use transcranial electrical stimulation (tES) which are transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) combined with conventional physical therapy and cognitive-motor dual task gait training in sub-acute (at least 2 weeks after stroke onset) to chronic (within 5 years post-stroke) to investigate the effect on cortical activity, spinal motoneuron excitability, cognition and motor performance. The findings may enhance the evidence to support usages of tES for improvimg cognition, motor performance as well as cortical activity and spinal motoneuron excitability in a clinical setting.
Read the detailed description
Stroke is a sudden neurological event which is leading cause of death and disability. An impaired blood flow and oxygen supply leading to neuronal cell death follwoing stroke. In addition, an electroencephalography demonstrated a decrease of high frequency power bands (alpha and beta) and increase of low frequency bands (theta and delta). An increase in delta frequency is negatively correlated with cognition, while an increase in high-frequency bands are correlatedw ith an improvement of motor recovery and cognition.
Follwoing stroke, an alterations of cortical activity between ipsileasional hemisphere and contralesion hemisphere affect the spinal lelvel as it leads to increase spinal motoneuron excitability. An increase of spinal motoneuron excitability is likely due to abnormal control from cortex to spinal cord via descending pathway. Furthermore, hyperexcitability of spinal motoneuron is associated with post-stroke spasticity. However, the excat mechanisms of spasticity in post stroke remians unclear. Potential causes include imbalance in descending pathway regulation, abnormal intraspinal processing, and altered muscular viscoelasticity. Changes in spinal motoneuron excitability can be assessed using Hoffmann's reflex (H-reflex).
Motor imapirments following stroke affects activities of daily living (ADLs), moreover cognitive impairements is commonly obsrved in post-stroke individuals that may limits motor and functional recovery and limits effectiveness of rehabilitation. These impairments affect both single- and duals-task activities, especially walking performance and increasing risk of falls in stroke individuals. In recent years, combining bottom-up and top-down approaches has been greater potential in promoting neural plasticity and enhancing motor recovery compared to single approach. Bottom-up approaches refers to rehabilitation that act on physical level and expected chnages in nervous system level, while top-down approach induce change in cortical level to induce change in motor function or physical level. The non-invasive brain stimulation (NIBS) is a top-down approach that enhance neural plasticity and mediated motor-relearning in neurological conditions. Transcranial electrical stimulation (tES) is one of NIBS which the most coom tES techniques are transcranial direct current stimulation (tDCS) and transcranial alternating currnt stimulation (tACS). Both tDCS and tACS are different in their wave forms. tDCS delivers a weak direct current with polartiy-specific effects, while tACS enhance neural plasticity and endogenous brain wave with frequency-specific. A recent review demonstrated the effectiveness of tDCS in improvement of motor function, functional abilities and cognitive function. Furthermore, a previous study demonstrated an improvement in cognitive function and ADLs following combining 2mA of tDCS with CMDT training. However, the amount of evidence on the effects of tACS is much less than that for tDCS, as it has only recently started to gain interest. The frequency used in tACS study mainly follows the association of brain wave and function. A previous review showed that gamma tACS enhance cognitive performance, working memory and logical thinking. In healthy population, a previous study demonstrated that applied gamma-tACS over M1 significantly improved velocity and acceleration of visuomotor task; nevertheless, this improvement did not found in beta-tACS. To provide evidence of the effects of tACS in the stroke population and to identify which type of transcranial electrical stimulation is most appropriate for stroke rehabilitation, a comparison between tDCS and tACS is necessary. Both tES technique will be combined with conventional physical therapy for 12 sessions (3 days/week for 4 weeks). tES will be provided for 20 minutes, then followed by convention physical therapy (1-hour) and cognitive-motor dual-task gait training (30-minute). Cortical activity will be assessed by EEG. Absoule spectral power of each frequency bands (alpha, beta, delta, and theta) will be analyze. The Hmax/Mmax ratio from flexor carpi radialis and soleus will be recorded to represent changes in spinal motoneuron excitability. The Fugl-Meyer assessment of upper and lower extremity and Timed up and go will be used to represent clinical outcomes of motor function and performance. The ERP recorded during Stroop color and word test and 2-Back test will be assessed together with the Montreal Cognitive Assessment (MoCA) in Thai version. Furthermore, behavoral data i.e. response time, accuracy will be collected to analyse to represent cogniton. For walking performance, dual-task interference or dual-task costs will be employed from dual-task walking. All outcomes will be assessed at baseline, post-intervention, 1-month follow-up, and 3-month follow-up.
- Being tested
- High-definition transcranial direct current stimulation (Active), High-definition transcranial alternating stimulation (Active), High-definition transcranial electrical stimulation (sham), Cognitive-motor dual task gait training, Conventional Physical therapy
- Keywords
- stroke, electroencephalography, event related potentials, rehabilitation, gait training, High-definition transcranial electrical stimulation
- Medical subject headings
- Hemorrhagic Stroke, Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-definition transcranial direct current stimulation (Active)Device
Also called HD-tDCS, starstim; Neuroelectrics, Spain
Electrode placement based on the international 10-20 electroencephalography electrode system. The electrode will be place over ipsilesional hemisphere on the primary motor cortex area. Anodal electrode will be placed over C3 or C4, while other 4 return electrodes will be placed over FC1/FC2, FC5/FC6, CP1/CP2, CP5/CP6. Participants will be asked to sit comfortably during stimulation. Participants will receive active HD-tDCS with intensity 2.0 mA for 20 minutes with 30-sec ramp-up and ramp-down.
High-definition transcranial alternating stimulation (Active)Device
Also called HD-tACS, starstim; Neuroelectrics, Spian
Electrode placement based on the international 10-20 electroencephalography electrode system. The electrode will be place over ipsilesional hemisphere on the primary motor cortex area. Anodal electrode will be placed over C3 or C4, while other 4 return electrodes will be placed over FC1/FC2, FC5/FC6, CP1/CP2, CP5/CP6. Participants will be asked to sit comfortably during stimulation. Participants will receive active HD-tACS with intensity 2.0 mA for 20 minutes with frequency 70 Hz.
High-definition transcranial electrical stimulation (sham)Device
Also called Sham stimulation, starstim; Neuroelectrics, Spian
Electrode placement based on the international 10-20 electroencephalography electrode system. The electrode will be place over ipsilesional hemisphere on the primary motor cortex area. Anodal electrode will be placed over C3 or C4, while other 4 return electrodes will be placed over FC1/FC2, FC5/FC6, CP1/CP2, CP5/CP6. Participants will be asked to sit comfortably during stimulation. Participants will receive active HD-tDCS with intensity 2.0 mA for 20 minutes with electrical current flows 1-minute, with 30-second ramp-up and ramp-down, and no electrical current flow after first 1 minute to the end of stimulation.
Cognitive-motor dual task gait trainingOther
Participants will be trained in cognitive-motor dual task gait training by using Zebris Rehawalk gait analysis and gait training. Participants will be asked to walk on treadmill while response to cognitive tasks on the computer screen, which is placed in front of participants. Treadmill speed will be set according to participants' preferred speed. Cognitive tasks involve color tasks and math tasks.
Conventional Physical therapyOther
Conventional physical therapy starts immediately after stimulation ends. In 1-hour of conventional physical therapy involving 10 minutes of upper and lower extremity stretching, 20 minutes of upper extremity training, and 30 minutes of lower extremity training.
| Study group | Role | What they receive |
|---|---|---|
| Active HD-tDCS with conventional physical therapy and CMDT gait training | Experimental | Participants will receive active tDCS for 20 minutes prior conventional physical therapy and CMDT gait training. They will be receive this intervention for 12 sessions (3 days/week for 4 weeks). Receives: Device: High-definition transcranial direct current stimulation (Active); Other: Cognitive-motor dual task gait training; Other: Conventional Physical therapy |
| Active HD-tACS with conventional physical therapy and CMDT gait training | Experimental | Participants will receive active tACS for 20 minutes prior conventional physical therapy and CMDT gait training. They will received this intervention for 12 sessions (3 days/week for 4 weeks). Receives: Device: High-definition transcranial alternating stimulation (Active); Other: Cognitive-motor dual task gait training; Other: Conventional Physical therapy |
| Sham stimulation witn conventional physical therapy and CMDT gait training | Sham comparator | Participants will receive sham stimulation for 30 minutes prior conventional physical therapy and CMDT gait training. They will received this intervention for 12 sessions (3 days/week for 4 weeks). Receives: Device: High-definition transcranial electrical stimulation (sham); Other: Cognitive-motor dual task gait training; Other: Conventional Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer assessment (FMA) of upper and lower extremities
The FMA is a clinical assessment that quantified level of motor impairement and evaluate recovery in post-stroke. The FMA Includes 33 items for the upper extremity and 17 items for the lower extremity, totaling 100 points. Higher scores indicate better motor performance.
Measured: Baseline, 1-day post-intervention, 1-month follow-up, and 3-month follow-up
Secondary outcomes (7)
Event Related Potential (ERP)
ERP is a non-invasive measurement tool that detects a very small voltage generated by brain activity in response to a specific event (i.e. Stroop test, N-back test). This is a signal averaging form of EEG that detects signals starting from the onset of a stimulus to evaluate brain responses over time, those occurring at 200 milliseconds (P200), or 300 milliseconds (P300) .
Measured: Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
Absolute power
The raw data from electroencephalographyt (EEG) in 5-min of eye-open and eye-close conditions converted to the power distribution of brain waves in different frequencies (i.e. delta, theta, and beta) usign a Fast Fourier Transformation (FFT)
Measured: Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is used to assess cognitive functioning in eight domains: Visuospatial and executive function, Naming, Attention, Language, Abstraction, Delayed recall, Orientation, Short-term memory. Participants are instructed to complete both paper-based and verbal question-answering activities, such as drawing pictures, sorting numbers, naming animals, and reviewing vocabulary. The maximum total score is 30 points, with a high score indicating a good level of cognitive.
Measured: Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
Timed up and go test
Participants wear regular footware and if they have normally used gait aid, it is allowed to use in the test. The test measures the time taken when the participants stand up from the chair, walk at normal pace for 3 meters, turn around, walk back for 3 meters, and then sit on a chair.
Measured: Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
Cognitive-motor interference (CMI)
CMI refers to a decline in performance observed when a person simultaneously performs a cognitive and motor task, compared to performing a single- or dual-task separately. Managing both tasks requires divided attention, and interference arises when these cognitive resources are insufficient to maintain performance in both domains. The CMI can be quantified by the dual-task cost (DTC). The DTC is calculated by comparing the performance difference between single-task and dual-task conditions. Participants will be asked to perform 2 walking conditions on the treadmill (Zebris Rehawalk gait analysis and gait training). The walking conditions are single-walking and cognitive-motor dual task walking (CMDT walking). For single-walking, participants will be asked to walk at their preferred speed. For CMDT walking, participants will walk and response to stimuli on the screen simultaneously. During the test, stride length, step length, cadence and accuracy of response
Measured: Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
Soleus H-reflex
The H-reflex is an electrophysiological measurement used to assess spinal excitability. For the soleus H-reflex , participants will be in prone position with ankle in neutral position. A bipolar electrode will be placed over the popliteal fossa, and the surface EMG electrode will be attached to the motor point of the soleus muscle (two electrodes on the lower 1/3 of the lower leg), and the lateral malleolus (ground electrode).
The electrical stimulation starts at a minimal intensity, increasing until an H-reflex response is detected, continuing to supramaximal intensity to elicit an M-wave. H-reflex latency, maximum H- and M-wave responses will be recorded. The Hmax/Mmax ratio will be calculated from maximum H- and M-wave amplitude responses.
Measured: Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
Flexor carpi radialis (FCR) H-reflexe
For the FCR H-reflex, participants will sit with their wrist in neutral, forearm mid-pronated, and their elbow flexed at 45 degrees, with slight shoulder abduction, flexion, and neutral rotation (68). Bipolar electrode will be placed medially to cubital fossa and the biceps brachii tendon. Two surface electrodes will be positioned over the FCR (1/3 of the distance from the medial epicondyle to the radial styloid), with a grounded electrode placed over radial styloid process. For the FCR H-reflex (Figure 10), participants will sit with their wrist in neutral, forearm mid-pronated, and their elbow flexed at 45 degrees, with slight shoulder abduction, flexion, and neutral rotation (68). Bipolar electrode will be placed medially to cubital fossa and the biceps brachii tendon. Two surface electrodes will be positioned over the FCR (1/3 of the distance from the medial epicondyle to the radial styloid) (69), with a grounded electrode placed over radial styloid process.
Measured: Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start20 Dec 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic StrokeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236216
- Sponsor's protocol ID
- MU-CIRB 2025/304.1106
- Status last verified
- Feb 2026
- First submitted
- 24 Sep 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Electrical Stimulation (tES) Combined With Cognitive-motor Dual-task Gait Training on Cortical Activity, Spinal Motoneuron Excitability, Cognition and Motor Performance in Stroke Individuals
- ClinicalTrials.gov ID
- NCT07236216
- Acronym / sponsor ID
- MU-CIRB 2025/304.1106
- Keywords
- stroke, electroencephalography, event related potentials, rehabilitation, gait training, High-definition transcranial electrical stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 19 Nov 2025 (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 present study will use transcranial electrical stimulation (tES) which are transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) combined with conventional physical therapy and cognitive-motor dual task gait training in sub-acute (at least 2 weeks after stroke onset) to chronic (within 5 years post-stroke) to investigate the effect on cortical activity, spinal motoneuron excitability, cognition and motor performance. The findings may enhance the evidence to support usages of tES for improvimg cognition, motor performance as well as cortical activity and spinal motoneuron excitability in a clinical setting.
Detailed description
Stroke is a sudden neurological event which is leading cause of death and disability. An impaired blood flow and oxygen supply leading to neuronal cell death follwoing stroke. In addition, an electroencephalography demonstrated a decrease of high frequency power bands (alpha and beta) and increase of low frequency bands (theta and delta). An increase in delta frequency is negatively correlated with cognition, while an increase in high-frequency bands are correlatedw ith an improvement of motor recovery and cognition.
Follwoing stroke, an alterations of cortical activity between ipsileasional hemisphere and contralesion hemisphere affect the spinal lelvel as it leads to increase spinal motoneuron excitability. An increase of spinal motoneuron excitability is likely due to abnormal control from cortex to spinal cord via descending pathway. Furthermore, hyperexcitability of spinal motoneuron is associated with post-stroke spasticity. However, the excat mechanisms of spasticity in post stroke remians unclear. Potential causes include imbalance in descending pathway regulation, abnormal intraspinal processing, and altered muscular viscoelasticity. Changes in spinal motoneuron excitability can be assessed using Hoffmann's reflex (H-reflex).
Motor imapirments following stroke affects activities of daily living (ADLs), moreover cognitive impairements is commonly obsrved in post-stroke individuals that may limits motor and functional recovery and limits effectiveness of rehabilitation. These impairments affect both single- and duals-task activities, especially walking performance and increasing risk of falls in stroke individuals. In recent years, combining bottom-up and top-down approaches has been greater potential in promoting neural plasticity and enhancing motor recovery compared to single approach. Bottom-up approaches refers to rehabilitation that act on physical level and expected chnages in nervous system level, while top-down approach induce change in cortical level to induce change in motor function or physical level. The non-invasive brain stimulation (NIBS) is a top-down approach that enhance neural plasticity and mediated motor-relearning in neurological conditions. Transcranial electrical stimulation (tES) is one of NIBS which the most coom tES techniques are transcranial direct current stimulation (tDCS) and transcranial alternating currnt stimulation (tACS). Both tDCS and tACS are different in their wave forms. tDCS delivers a weak direct current with polartiy-specific effects, while tACS enhance neural plasticity and endogenous brain wave with frequency-specific. A recent review demonstrated the effectiveness of tDCS in improvement of motor function, functional abilities and cognitive function. Furthermore, a previous study demonstrated an improvement in cognitive function and ADLs following combining 2mA of tDCS with CMDT training. However, the amount of evidence on the effects of tACS is much less than that for tDCS, as it has only recently started to gain interest. The frequency used in tACS study mainly follows the association of brain wave and function. A previous review showed that gamma tACS enhance cognitive performance, working memory and logical thinking. In healthy population, a previous study demonstrated that applied gamma-tACS over M1 significantly improved velocity and acceleration of visuomotor task; nevertheless, this improvement did not found in beta-tACS. To provide evidence of the effects of tACS in the stroke population and to identify which type of transcranial electrical stimulation is most appropriate for stroke rehabilitation, a comparison between tDCS and tACS is necessary. Both tES technique will be combined with conventional physical therapy for 12 sessions (3 days/week for 4 weeks). tES will be provided for 20 minutes, then followed by convention physical therapy (1-hour) and cognitive-motor dual-task gait training (30-minute). Cortical activity will be assessed by EEG. Absoule spectral power of each frequency bands (alpha, beta, delta, and theta) will be analyze. The Hmax/Mmax ratio from flexor carpi radialis and soleus will be recorded to represent changes in spinal motoneuron excitability. The Fugl-Meyer assessment of upper and lower extremity and Timed up and go will be used to represent clinical outcomes of motor function and performance. The ERP recorded during Stroop color and word test and 2-Back test will be assessed together with the Montreal Cognitive Assessment (MoCA) in Thai version. Furthermore, behavoral data i.e. response time, accuracy will be collected to analyse to represent cogniton. For walking performance, dual-task interference or dual-task costs will be employed from dual-task walking. All outcomes will be assessed at baseline, post-intervention, 1-month follow-up, and 3-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active HD-tDCS with conventional physical therapy and CMDT gait training | Experimental | Device: High-definition transcranial direct current stimulation (Active), Other: Cognitive-motor dual task gait training, Other: Conventional Physical therapyParticipants will receive active tDCS for 20 minutes prior conventional physical therapy and CMDT gait training. They will be receive this intervention for 12 sessions (3 days/week for 4 weeks). |
| Active HD-tACS with conventional physical therapy and CMDT gait training | Experimental | Device: High-definition transcranial alternating stimulation (Active), Other: Cognitive-motor dual task gait training, Other: Conventional Physical therapyParticipants will receive active tACS for 20 minutes prior conventional physical therapy and CMDT gait training. They will received this intervention for 12 sessions (3 days/week for 4 weeks). |
| Sham stimulation witn conventional physical therapy and CMDT gait training | Sham comparator | Device: High-definition transcranial electrical stimulation (sham), Other: Cognitive-motor dual task gait training, Other: Conventional Physical therapyParticipants will receive sham stimulation for 30 minutes prior conventional physical therapy and CMDT gait training. They will received this intervention for 12 sessions (3 days/week for 4 weeks). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral stroke individuals aged 18-80 years.
- A first-ever stroke.
- Stroke onset from at least 2 weeks-5 years.
- Able to walk independently with or without gait aids (modified Rankin scale (mRS) 1-3)
- Montreal cognitive Assessment-Thai version (MoCA-T) greater than or equal to 20 scores.
Key exclusion criteria (8 listed)
- Presence of any psychological or neurological antecedent, unstable medical conditions or condition that may increase risk of stimulation such as epilepsy, seizure, and history of brain injury
- Having unstable cardiovascular disease or respiratory disease, and uncontrolled chronic disease such as diabetes mellitus (DM), hypertension (HT) and chronic kidney disease (CKD)
- Receiving other non-invasive brain stimulation or additional intervention such as TMS, PMS or acupuncture
- Presence of metal implantation, intracranial shunt, cochlear implantation, or cardiac pacemakers.
- Presence of an opened wound, infectious wound around scalp or craniectomy with unreplaced bone flap
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 |
|---|---|---|
| High-definition transcranial direct current stimulation (Active)Also: HD-tDCS, starstim; Neuroelectrics, SpainElectrode placement based on the international 10-20 electroencephalography electrode system. The electrode will be place over ipsilesional hemisphere on the primary motor cortex area. Anodal electrode will be placed over C3 or C4, while other 4 return electrodes will be placed over FC1/FC2, FC5/FC6, CP1/CP2, CP5/CP6. Participants will be asked to sit comfortably during stimulation. Participants will receive active HD-tDCS with intensity 2.0 mA for 20 minutes with 30-sec ramp-up and ramp-down. | Device | Active HD-tDCS with conventional physical therapy and CMDT gait training |
| High-definition transcranial alternating stimulation (Active)Also: HD-tACS, starstim; Neuroelectrics, SpianElectrode placement based on the international 10-20 electroencephalography electrode system. The electrode will be place over ipsilesional hemisphere on the primary motor cortex area. Anodal electrode will be placed over C3 or C4, while other 4 return electrodes will be placed over FC1/FC2, FC5/FC6, CP1/CP2, CP5/CP6. Participants will be asked to sit comfortably during stimulation. Participants will receive active HD-tACS with intensity 2.0 mA for 20 minutes with frequency 70 Hz. | Device | Active HD-tACS with conventional physical therapy and CMDT gait training |
| High-definition transcranial electrical stimulation (sham)Also: Sham stimulation, starstim; Neuroelectrics, SpianElectrode placement based on the international 10-20 electroencephalography electrode system. The electrode will be place over ipsilesional hemisphere on the primary motor cortex area. Anodal electrode will be placed over C3 or C4, while other 4 return electrodes will be placed over FC1/FC2, FC5/FC6, CP1/CP2, CP5/CP6. Participants will be asked to sit comfortably during stimulation. Participants will receive active HD-tDCS with intensity 2.0 mA for 20 minutes with electrical current flows 1-minute, with 30-second ramp-up and ramp-down, and no electrical current flow after first 1 minute to the end of stimulation. | Device | Sham stimulation witn conventional physical therapy and CMDT gait training |
| Cognitive-motor dual task gait trainingParticipants will be trained in cognitive-motor dual task gait training by using Zebris Rehawalk gait analysis and gait training. Participants will be asked to walk on treadmill while response to cognitive tasks on the computer screen, which is placed in front of participants. Treadmill speed will be set according to participants' preferred speed. Cognitive tasks involve color tasks and math tasks. | Other | Active HD-tACS with conventional physical therapy and CMDT gait training, Active HD-tDCS with conventional physical therapy and CMDT gait training, Sham stimulation witn conventional physical therapy and CMDT gait training |
| Conventional Physical therapyConventional physical therapy starts immediately after stimulation ends. In 1-hour of conventional physical therapy involving 10 minutes of upper and lower extremity stretching, 20 minutes of upper extremity training, and 30 minutes of lower extremity training. | Other | Active HD-tACS with conventional physical therapy and CMDT gait training, Active HD-tDCS with conventional physical therapy and CMDT gait training, Sham stimulation witn conventional physical therapy and CMDT gait training |
Primary outcome
Fugl-Meyer assessment (FMA) of upper and lower extremities
Time frame: Baseline, 1-day post-intervention, 1-month follow-up, and 3-month follow-up
The FMA is a clinical assessment that quantified level of motor impairement and evaluate recovery in post-stroke. The FMA Includes 33 items for the upper extremity and 17 items for the lower extremity, totaling 100 points. Higher scores indicate better motor performance.
7 secondary outcomes
Event Related Potential (ERP)
Time frame: Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
Absolute power
Time frame: Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
Montreal Cognitive Assessment
Time frame: Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
Timed up and go test
Time frame: Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
Cognitive-motor interference (CMI)
Time frame: Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
Soleus H-reflex
Time frame: Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
Flexor carpi radialis (FCR) H-reflexe
Time frame: Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Acute Ischemic Stroke, Acute Haemorrhagic Stroke
Recruiting
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
Stroke, Ischemic, Chronic Stroke
RecruitingPhase 3
Thrombolysis in Factor Xa-inhibitors Trial
Stroke, Stroke (in Patients With Atrial Fibrillation)
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-definition transcranial direct current stimulation (Active), High-definition transcranial alternating stimulation (Active) and Cognitive-motor dual task gait training in people with Hemorrhagic Stroke and Ischemic Stroke, run by Mahidol University at 1 site in Thailand.
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 6 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanalee Klomjai, PhD (+6624415450 ext. 20216, wanalee.klo@mahidol.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer assessment (FMA) of upper and lower extremities (time frame: Baseline, 1-day post-intervention, 1-month follow-up, and 3-month follow-up). 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 Feb 2026.