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Ischemic StrokeNCT06134921

Effects of Transcranial Electrical Stimulation in Stroke Individuals

A study testing transcranial direct current stimulation (Active), transcranial alternating current stimulation (active) and Conventional physical therapy program in people with Ischemic Stroke and Hemorrhagic Stroke, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present study will use transcranial electrical stimulation (tES) with conventional physical therapy in sub-acute (at least 2 weeks after stroke onset) to chronic stroke within 2 years to investigate the effect on cortical activity and upper and lower limb motor function. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
transcranial direct current stimulation (Active), transcranial alternating current stimulation (active) and Conventional physical therapy program
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
15 Nov 2023to 30 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

  • Stroke individuals aged 18 - 80 years.
  • A first-ever unilateral ischemic or hemorrhagic stroke.
  • Stroke onset from at least 2 weeks - 2 years.
  • Having modified Rankin scale (mRS) 1-4
  • Ability to communicate, follow, and understand the instruction.

Who cannot join

  • Presence of any neurological antecedent, unstable medical conditions or condition that may increase risk of stimulation such as epilepsy and seizure, and history of brain surgery.
  • Presence of metal implantation, intracranial shunt, cochlear implantation, or cardiac pacemakers.
  • Presence of opened wound or infectious wound around the scalp.
  • Moderate pain in any joint of the upper or lower paretic limb (numerical pain rating score > 4/10).
  • History of receiving non-invasive brain stimulation within the past 6 months.

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Faculty of Physical Therapy, Mahidol University

    Salaya, Nakonpathom, 73170

Other trials in Thailand

About this study

Official title: The Effects of Bilateral-Transcranial Electrical Stimulation (tES) on Cortical Activity, Motor Performances, and Cognitive Function in Sub-Acute and Chronic Stroke Individuals

The present study will use transcranial electrical stimulation (tES) with conventional physical therapy in sub-acute (at least 2 weeks after stroke onset) to chronic stroke within 2 years to investigate the effect on cortical activity and upper and lower limb motor function. The findings may support the usage of tES for improving brain activity and motor function in a clinic setting.

Read the detailed description

Stroke is a leading cause of death and disability in the world. The prevalence of stroke is high in developing countries; for example in Thailand, stroke is one of a leading cause of death and disability. The estimate prevalence among adults aged 45 years and older is 1.88%, and the mortal rate of stroke is still has continued to increase over the past 5 years. Globally, 87 percent of stroke people have suffered from ischemic stroke while 13% suffered from hemorrhagic stroke. Fifty-seven percent stroke cases remains disability reported by the world stroke organization. Motor impairment is a major limit post-stroke and it affects activities in daily life. Cognitive impairments (i.e., executive function, attention, and memory) are commonly observed in post-stroke survivors which may lead decrease in functional capacity and affects the efficacy of rehabilitation in stroke.

Stroke is defined as a sudden neurological explosion caused by impaired perfusion through the blood vessels to the brain. Ischemic stroke is caused by deficient blood flow and oxygen supply to the brain, while, hemorrhagic stroke is caused by bleeding or leaky blood vessels, resulting in cell death. After-stroke, cortical excitability decreases in the ipsilesional hemisphere and increases in the contralesional hemisphere. Consequently, there is an imbalance in the interhemispheric inhibition (IHI) between both hemispheres. The onset of IHI imbalance in stroke patients remains unclear, although the occurrence of motor impairment since the onset. However, the IHI imbalance is remained throughout stroke life. The imbalance of IHI was found to be negatively correlated with stroke motor recovery; a greater imbalance was associated with a poorer motor performance. IHI imbalance is not a cause of poor motor recovery, but instead might be the consequence of underlying recovery processes.

An electroencephalography (EEG) is the non-invasive measurement tool with high temporal resolution, which can detect a summary of the postsynaptic electrical signals of pyramidal neurons in the cortical layers. EEG is a useful measurement after stroke. Several metrics have been found to be related to recovery across all stroke phases. A recent review in 2022 reported that brain symmetry index (BSI) and spectral power are the most efficacious metrics to use to predict stroke recovery. BSI is one of the more popular EEG-derived parameters use to quantify the mean spectral asymmetry between the two hemispheres. It has a normal range of 0 to 1, where 0 indicates perfect symmetry, while 1 indicates maximal asymmetry. BSI was significantly higher in stroke patients indicating brain asymmetry compared with healthy controls Van Putten and Tavy demonstrated in acute ischemic stroke people that BSI was unchanged within 24 hours post-stroke, however it had a positive correlation between the National Institutes of Health Stroke Scale (NIHSS); a higher impairment, a higher brain asymmetry. It was reported that higher BSI value in the acute to sub-acute phase were associated with lower motor performance in 4 weeks later implying that BSI could possibly aid in prognostication of motor outcome during stroke recovery phase. Moreover, spectral power analysis in stroke individuals showed fluctuation of brain oscillation caused by cell death such as an increase of low frequency power (delta and theta) in the ipsilesional hemisphere that occurred as early as one minute after stroke, whereas high frequency power (alpha and beta) were decreased. An increase in delta activity post-stroke was also negatively corelated to cognitive functioning. Cortical activity in recovery phase can represent motor recovery and cognitive function post-stroke. An increase of high-frequency brain wave (i.e. beta band) is related to improve motor recovery in subacute and chronic phases of stroke. In addition, increase of alpha band and decrease of delta band correlated with improve cognitive function in stroke survivors.

Motor recovery post-stroke rapidly increase within first 3 months (acute to early subacute phase) and less significant recovery subsequently in late-subacute (3-6 months), then, spontaneous recovery is leading to a stable at its limit in chronic phase (>6 months), but the recovery can expand up to 2 years post-stroke after receiving rehabilitation. Therefore, the rehabilitation can enhance stroke recovery beyond spontaneous recovery in the subacute and chronic phases. There are 2 factors influencing stroke recovery: 1) intrinsic factors which are age, sex, stroke onset, stroke type, severity, co-morbidities, socioeconomic status, and genetic profiles, 2) extrinsic factors such as caregiver support, pharmacology, and rehabilitation program in which consists of bottom-up and top-down approaches. Rehabilitation post-stroke is recommended to enhance recovery and reduce long-term disability. The guideline of American Stroke Association (ASA) has recommended that patients with stroke required therapeutic intervention of at least 3 times per week for 20-60 min per session.

Non-invasive brain stimulation (NIBS) i.e., transcranial Electrical stimulation (tES) is a top-down approach that has been recommended to use as an add-on intervention in rehabilitation post-stroke. The most common tES techniques used in research are 1) transcranial Direct Current Stimulation (tDCS) and 2) transcranial Alternating Current Stimulation (tACS). The difference between these two tES techniques is the current forms elicited.

  1. tDCS delivers weak direct current to modulate cortical excitability with polarity-specific effects. Within dose limited, anodal tDCS enhances cortical excitability while cathodal tDCS decreases it. There are several studies reported the effect of tDCS on physical and cognitive performance in healthy subjects as well as in people with neurological disorders. To promote rebalancing of IHI, tDCS is used by applying anodal electrode over the ipsilesional hemisphere and cathodal electrode over the contralesional hemisphere simultaneously, called dual- or bilateral-tDCS. Many meta-analysis and individuals studies demonstrated that bilateral-tDCS over the primary motor cortex (M1) was more efficient for improving upper and lower limbs motor performances compared to other montages. Most of previous studies employed different intensities of 2 mA with duration of stimulation for 20 minutes. However, a recent meta-analysis suggested that a stimulation duration greater than 20 minutes to increase stimulation duration and number of stimulation session during 15 - 20 sessions were effective to enhance the effect of tDCS on motor function. For cognitive function, a recent meta-analysis reported the positive effect of tDCS applied over the dorsolateral prefrontal cortex (DLPFC) on cognitive function recovery compared with sham in stroke population. A previous study reported that tDCS targeting M1 combined with motor training could improve motor and cognitive performance, although the effect may less compared with targeting DLPFC.
  2. tACS delivers alternating electrical current to modulate cortical excitability and endogenous brain oscillation with the frequency-specific. The activity of alpha (8-12 Hz) and beta (13-30 Hz) frequency is prominent in the human sensorimotor cortex during the resting-state. From a meta-analysis, tACS delivered at the beta frequency range could increase cortical excitability of the primary motor cortex. This effect is particularly pronounced when stimulation intensity was above 1 mA. In healthy populations, some studies have shown that a beta-tACS applied over the M1 could improve motor learning, and a greater effect was found when compared to alpha-tACS. Same observation was reported in stroke population, beta-tACS (20 Hz) at 1 mA induced greater modulation effects compared to alpha-tACS (10 Hz at 1 mA in the motor-related regions. Ten-session of tACS at 2mA over the M1 of the affected hemisphere with gait training could improve gait performance in individuals with chronic stroke. tACS appears to have potential for motor recovery post-stroke as other NIBS, but relevant numbers of randomized controlled trials (RCT) in stroke population are very limited compared to those of tDCS. Both tDCS and tACS are portable, easy to operate and induce only mild adverse effects. To now, there are few studies comparing the effects of tDCS with tACS. In terms of efficacy in cortical excitability alteration, with similar stimulation patterns (1.0 mA and 10 min), tACS significantly increased cortical excitability compared with sham in healthy subjects, however tDCS was not greater over sham. In term of motor performance, both beta-tACS (20 Hz) and anodal-tDCS over the M1 could increase reaction time in healthy subjects, with no significant difference on retrieval. However, in people with mild cognitive impairment, it was shown that tACS (40 Hz) applied over the DLPFC at 2 mA increase beta activity and cognitive function in comparison with 2 mA-tDCS and sham. tACS appeared to be superior to tDCS in improving cognitive outcomes.

Up to now, there is no study comparing the effects of tDCS and tACS in stroke population, especially on motor performance. To improve motor performance, the M1 is the most common target of electrical stimulation. Moreover, M1 stimulation together with motor training has been reported to improve motor and cognitive performance, The present study will investigate the effects of tDCS and tACS applied over the M1 combined with physical therapy on cortical activity, motor and cognitive outcomes in individuals with stroke in sub-acute and chronic phase within 2 years post stroke. Both tES techniques will be combined with conventional physical therapy for 15 sessions (3 days per week, 5 weeks) following by motor training as recommended by ASA. Cortical activity will be assessed by EEG and served as a primary outcome. Absolute spectral power of each frequency bands (alpha, beta, delta, theta) will be analyzed. Moreover, analysis of brain activity will be focused on brain symmetry index (BSI) which represents the balance between the contralesional and the ipsilesional hemispheres. Clinical outcomes will be served as a secondary outcome, for upper limb performance evaluations will consist of Fugl-Meyer assessment of upper (FMA-UE) and Wolf Motor Function Test (WMFT). For lower limb performance will be Fugl-Meyer assessment of lower (FMA-LE) and Timed Up and Go test (TUG). Five Time Sit to Stand (FTST), gait analysis and balance by using Zebris Force Distribution Measurement-T software and platform (FDM). Cognitive function will be examined by Montreal Cognitive Assessment (MoCA) in Thai version. All outcomes will be assessed at before-, post-intervention and 1-month and 3-month follow-ups.

Being tested
transcranial direct current stimulation (Active), transcranial alternating current stimulation (active), transcranial electrical stimulation (sham), Conventional physical therapy program
Keywords
transcranial electrical stimulation, stroke, electroencephalography, rehabilitation
Medical subject headings
Ischemic Stroke, Hemorrhagic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcranial direct current stimulation (Active)Device

    Also called tDCS (Active), innk; Neurophet, Korea

    Electrode placement based on the international 10 - 20 electroencephalography electrode system for the cathodal electrode will be applied over the contralesional hemisphere. In contrast, an anodal electrode will be applied over the ipsilesional hemisphere on the primary motor cortex (C3 or C4). Participants will be asked to sit comfortably during stimulation.

    In the Active-tDCS group, participants will receive real tDCS with intensity 2.0 mA for 30 minutes, with a 30-second ramp-up and ramp-down.

  • transcranial alternating current stimulation (active)Device

    Also called tACS (Active), innk; Neurophet, Korea

    Electrode placement based on the international 10 - 20 electroencephalography electrode system for the cathodal electrode will be applied over the contralesional hemisphere. In contrast, an anodal electrode will be applied over the ipsilesional hemisphere on the primary motor cortex (C3 or C4). Participants will be asked to sit comfortably during stimulation.

  • transcranial electrical stimulation (sham)Device

    Also called Sham stimulation, innk; Neurophet, Korea

    Electrode placement based on the international 10 - 20 electroencephalography electrode system for applied the cathodal electrode will be applied over the contralesional hemisphere. In contrast, an anodal electrode will be applied over the ipsilesional hemisphere on the primary motor cortex (C3 or C4). Participants will be asked to sit comfortably during stimulation.

    In the Sham group, participants will receive sham stimulation with intensity 2.0 mA for 1 minute, with a 30-second ramp-up and ramp-down, and no stimulation until the end of 30 minutes of stimulation. Electrodes will remain for 30 minutes.

  • Conventional physical therapy programOther

    A conventional physical therapy program will be provided after 30 minutes of stimulation immediately. The program will be provided for both upper and lower limbs which consist of stretching exercise, active exercise, and functional exercise.

Study groups in NCT06134921
Study groupRoleWhat they receive
Active tDCS and conventional physical therapy programExperimentalParticipants will receive Active tDCS for 30 minutes prior conventional physical therapy program. They will be asked to perform this combination therapy for 15 sessions, occurring three times a week for five weeks.
Receives: Device: transcranial direct current stimulation (Active); Other: Conventional physical therapy program
Active tACS and conventional physical therapy programExperimentalParticipants will receive Active tACS for 30 minutes prior conventional physical therapy program. They will be asked to perform this combination therapy for 15 sessions, occurring three times a week for five weeks.
Receives: Device: transcranial alternating current stimulation (active); Other: Conventional physical therapy program
Sham stimulation and conventional physical therapy programSham comparatorParticipants will receive sham stimulation for 30 minutes prior conventional physical therapy program. They will be asked to perform this combination therapy for 15 sessions, occurring three times a week for five weeks.
Receives: Device: transcranial electrical stimulation (sham); Other: Conventional physical therapy program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer Assessment (FMA) of upper and lower extremities

    The Fugl-Meyer Assessmen is used to quantify motor impairment and recovery post-stroke. The participants will use their unaffected side to perform first, and then subsequently perform their affected side in each movement 3 times. The best movement will be scored. The best performance was scored through direct observation as follows: 0=could not perform, 1= performed partially, and 2= performed fully. There was a total score of 100 (66 and 34 points for the upper and lower limbs, respectively

    Measured: Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention

Secondary outcomes (8)
  1. Brain symmetry index (BSI)

    The data from the absolute power will be used to calculate brain symmetry value ranged from 0-1( 0 represents perfect symmetry and 1 represents maximal asymmetry).

    Measured: Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention

  2. Absolute power

    The raw data from electroencephalography (EEG) in 5-min of eye-opened and eye-closed conditions converted to the power distribution of brain waves in different frequencies (i.e., delta, theta, alpha, and beta) by using Fast Fourier Transformation (FFT)

    Measured: Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention

  3. Timed Up and Go test

    Participants wear regular footwear 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, post-intervention at week 5, 1-month and 3-month after post-intervention

  4. Five-Time Sit to Stand Test

    The participants sit with the back lean against the chair, stand up and sit down 5 times as quickly as possible while keeping arm crossed throughout the test.

    Measured: Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention

  5. Spatiotemporal gait variables

    Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze the gait cycle. The force plate detects the force and weight bearing of the patient's feet and then calculates as step length in centimeters (cm).

    Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.

    Measured: Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention

  6. Spatiotemporal gait variables

    Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze the gait cycle. The force plate detects the force and weight bearing of the patient's feet and then calculates as single limb support (%).

    Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.

    Measured: Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention

  7. Spatiotemporal gait variables

    Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze the gait cycle. The force plate detects the force and weight bearing of the patient's feet and then calculates as gait velocity (m/s).

    Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.

    Measured: Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention

  8. Montreal Cognitive Assessment

    The MoCA-Thai version will be used to assess cognitive function. All participants will be tested for all domains excepting executive function and visuospatial ability since some participants may unable to complete the written portion.

    Measured: Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start15 Nov 2023
  3. Primary completion30 Dec 2024
  4. Study completion30 Apr 2025

Resources

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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06134921
Sponsor's protocol ID
MU-CIRB 2023/288.1509
Status last verified
Feb 2026
First submitted
2 Nov 2023
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing transcranial direct current stimulation (Active), transcranial alternating current stimulation (active) and Conventional physical therapy program in people with Ischemic Stroke and Hemorrhagic 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 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 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?

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?

Fugl-Meyer Assessment (FMA) of upper and lower extremities (time frame: Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention). 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 24 Feb 2026.

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