Hemorrhagic StrokeNCT07433972
Changes in Hemodynamic Response Following Transcranial Electrical Stimulation in Sroke Individuals
A study testing Transcranial direct current stimulation, transcranial alternating current stimulation and Rehabilitation program 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 dualt ask 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?
- Transcranial direct current stimulation, transcranial alternating current stimulation and Rehabilitation 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
- 1 Mar 2026to 30 Mar 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
Salaya, Changwat Nakhon Pathom, 73170
Wanalee Klomjai, PhD, +6624415450 ext. 20216, wanalee.klo@mahidol.edu
Wanalee Klomjai, PhD
About this study
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 dualt ask gait training in sub-acute (at least 2 weeks after stroke onset) to chronic stroke (within 5 years post-stroke) to investigate changes in brain hemodynamics (oxy-hemoglobin and deoxy-hemoglobin concentration) as measured by functional near infrared spectroscopy (fNIRS). The findings may provides insights changes in combining tES with rehabilitation on improvements in brain hemodynamics in sub-acute to chronic stroke.
Read the detailed description
Stroke is a sudden neurological event which caused by an impaired blood flow and oxygen suppley, leading to neuronal cell death. An impaired in neuronal cell death and blood flow to the brain leads to imapirement in motor and cognitive function as well as disability in post-stroke individuals. To investigate changes in cerebral blood flow and oxygen comsumption, functional near-infrared spectroscpoy (fNIRS) which is a non-invasive neuroimaging can monitors alterations in blood flow and oxygenconsumption in the brain. Furthermore, fNIRS can be use as an outcome predictors and outcome measures for rehabilitation following stroke.
Motor impairments following stroke affects activities of daily living (ADLs), moreover, cognitive impairments is commonly observed in post-stroke individuals that may limits and functional recovery and limites effectiveness of rehabilitation. These impairments affect both single- and duals-task activities, especially walking performance and increasing risk of falls in stroke individuals. In previous study laterations in cerebral blood flow was obsered during stroke individuals performing dual-task walking, indicating alterations in cortical activity during this activity. Furthermore, combining bottom-up and top-down approaches provide greater beneficial on improvement motor and cognitive function in stroke individuals. Transcranial electrical stimulation (tES), a non-invasive brain stimulation (NIBS) that can facilitates cortical activity and adjuncent intervention to combine with rehabilitation to facilitate greater rehabilitation outcome in stroke inidividuals. The most common tES technique are transcranial direct current stimulation (tDCS) and transcranial alternating current 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. Furthermore, changes in brain hemodynamic responses remains unclear. To provide insights on changes in brain hemodynamic response following combining tES with conventional physical therapy and cognitive-motor dual task gait training in stroke individuals. This study will provide the combining of 12 sessions of tES with conventional physical therapy and cognitive motor-dual task gait training. Changes in brain hemodynamics response will be assessed using fNIRS. The oxy-hemoglobin and deoxy-hemoglobin will be recorded and analyze to represent changes of blood flow to the brain after intervention.
- Being tested
- Transcranial direct current stimulation, transcranial alternating current stimulation, Rehabilitation program, transcranial electrical stimulation (Sham)
- Keywords
- Stroke, functional near-infrared spectroscopy, rehbailitation, 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.
Transcranial direct current stimulationDevice
The direct current is set at 2.0 mA, delivered for 20 minutes with ramp-up and ramp-down for 30 seconds. The electrodes are placed over lesional M1
transcranial alternating current stimulationDevice
The alternating current is set at 2.0 mA, 70 Hz delivered for 20 minutes with ramp-up and ramp-down for 30 seconds. The electrodes are placed over lesional M1
Rehabilitation programOther
Conventional physical therapy and cognitive motor-dual task gait training will be provided immediately after stimulation ends. The rehabilitation program will be provided by licensed physiotherapist
transcranial electrical stimulation (Sham)Device
The direct current is set at 2.0 mA delivered for 1 minutes with ramp-up and ramp-down for 30 seconds. However, participants remains wearing electrodes cap until 20 minutes. The electrodes are placed over lesional M1
| Study group | Role | What they receive |
|---|---|---|
| transcranial direct current stimulation with rehabilitation | Active comparator | Participants received active tDCS for 20 minutes followed by rehabilitation program for 12 sessions (3 days/week, 4 weeks) Receives: Device: Transcranial direct current stimulation; Other: Rehabilitation program |
| transcranial alternating current stimulation with rehabilitation | Active comparator | Participants received active tACS for 20 minutes followed by rehabilitation program for 12 sessions (3 days/ week, 4 weeks) Receives: Device: transcranial alternating current stimulation; Other: Rehabilitation program |
| sham stimulation with rehabilitation | Sham comparator | Participants receive sham tDCS for 20 minutes with electrical current delivered only 1 minutes followed by rehabilitation program for 12 sessions (3 days/ week, 4 weeks) Receives: Other: Rehabilitation program; Device: transcranial electrical stimulation (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygen level
Changes in concentration of hemoglobin between oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (HbR) in the brain, which can indicate brain function in different areas are assessed by Functional Near-Infrared Spectroscopy (fNIRS)
Measured: Baseline, 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 posted25 Feb 2026
- Study start1 Mar 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 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
- NCT07433972
- Sponsor's protocol ID
- fNIRS MU-CIRB 2025/304.1106
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 8 Oct 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Hemodynamic Response Following Transcranial Electrical Stimulation in Sroke Individuals
- ClinicalTrials.gov ID
- NCT07433972
- Acronym / sponsor ID
- fNIRS MU-CIRB 2025/304.1106
- Keywords
- Stroke, functional near-infrared spectroscopy, rehbailitation, transcranial electrical stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 25 Feb 2026 (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 dualt ask gait training in sub-acute (at least 2 weeks after stroke onset) to chronic stroke (within 5 years post-stroke) to investigate changes in brain hemodynamics (oxy-hemoglobin and deoxy-hemoglobin concentration) as measured by functional near infrared spectroscopy (fNIRS). The findings may provides insights changes in combining tES with rehabilitation on improvements in brain hemodynamics in sub-acute to chronic stroke.
Detailed description
Stroke is a sudden neurological event which caused by an impaired blood flow and oxygen suppley, leading to neuronal cell death. An impaired in neuronal cell death and blood flow to the brain leads to imapirement in motor and cognitive function as well as disability in post-stroke individuals. To investigate changes in cerebral blood flow and oxygen comsumption, functional near-infrared spectroscpoy (fNIRS) which is a non-invasive neuroimaging can monitors alterations in blood flow and oxygenconsumption in the brain. Furthermore, fNIRS can be use as an outcome predictors and outcome measures for rehabilitation following stroke.
Motor impairments following stroke affects activities of daily living (ADLs), moreover, cognitive impairments is commonly observed in post-stroke individuals that may limits and functional recovery and limites effectiveness of rehabilitation. These impairments affect both single- and duals-task activities, especially walking performance and increasing risk of falls in stroke individuals. In previous study laterations in cerebral blood flow was obsered during stroke individuals performing dual-task walking, indicating alterations in cortical activity during this activity. Furthermore, combining bottom-up and top-down approaches provide greater beneficial on improvement motor and cognitive function in stroke individuals. Transcranial electrical stimulation (tES), a non-invasive brain stimulation (NIBS) that can facilitates cortical activity and adjuncent intervention to combine with rehabilitation to facilitate greater rehabilitation outcome in stroke inidividuals. The most common tES technique are transcranial direct current stimulation (tDCS) and transcranial alternating current 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. Furthermore, changes in brain hemodynamic responses remains unclear. To provide insights on changes in brain hemodynamic response following combining tES with conventional physical therapy and cognitive-motor dual task gait training in stroke individuals. This study will provide the combining of 12 sessions of tES with conventional physical therapy and cognitive motor-dual task gait training. Changes in brain hemodynamics response will be assessed using fNIRS. The oxy-hemoglobin and deoxy-hemoglobin will be recorded and analyze to represent changes of blood flow to the brain after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| transcranial direct current stimulation with rehabilitation | Active comparator | Device: Transcranial direct current stimulation, Other: Rehabilitation programParticipants received active tDCS for 20 minutes followed by rehabilitation program for 12 sessions (3 days/week, 4 weeks) |
| transcranial alternating current stimulation with rehabilitation | Active comparator | Device: transcranial alternating current stimulation, Other: Rehabilitation programParticipants received active tACS for 20 minutes followed by rehabilitation program for 12 sessions (3 days/ week, 4 weeks) |
| sham stimulation with rehabilitation | Sham comparator | Other: Rehabilitation program, Device: transcranial electrical stimulation (Sham)Participants receive sham tDCS for 20 minutes with electrical current delivered only 1 minutes followed by rehabilitation program for 12 sessions (3 days/ week, 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 |
|---|---|---|
| Transcranial direct current stimulationThe direct current is set at 2.0 mA, delivered for 20 minutes with ramp-up and ramp-down for 30 seconds. The electrodes are placed over lesional M1 | Device | transcranial direct current stimulation with rehabilitation |
| transcranial alternating current stimulationThe alternating current is set at 2.0 mA, 70 Hz delivered for 20 minutes with ramp-up and ramp-down for 30 seconds. The electrodes are placed over lesional M1 | Device | transcranial alternating current stimulation with rehabilitation |
| Rehabilitation programConventional physical therapy and cognitive motor-dual task gait training will be provided immediately after stimulation ends. The rehabilitation program will be provided by licensed physiotherapist | Other | sham stimulation with rehabilitation, transcranial alternating current stimulation with rehabilitation, transcranial direct current stimulation with rehabilitation |
| transcranial electrical stimulation (Sham)The direct current is set at 2.0 mA delivered for 1 minutes with ramp-up and ramp-down for 30 seconds. However, participants remains wearing electrodes cap until 20 minutes. The electrodes are placed over lesional M1 | Device | sham stimulation with rehabilitation |
Primary outcome
Blood oxygen level
Time frame: Baseline, Post-intervention, 1-month follow-up and 3-month follow-up
Changes in concentration of hemoglobin between oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (HbR) in the brain, which can indicate brain function in different areas are assessed by Functional Near-Infrared Spectroscopy (fNIRS)
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 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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 direct current stimulation, transcranial alternating current stimulation and Rehabilitation program 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 8 Oct 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?
Blood oxygen level (time frame: Baseline, 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 8 Oct 2026.