Changes in Hemodynamic Response Following Transcranial Electrical Stimulation in Sroke Individuals
1 other identifier
interventional
60
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2026
CompletedFirst Posted
Study publicly available on registry
February 25, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
February 25, 2026
February 1, 2026
10 months
February 19, 2026
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Baseline, Post-intervention, 1-month follow-up and 3-month follow-up
Study Arms (3)
transcranial direct current stimulation with rehabilitation
ACTIVE COMPARATORParticipants 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 COMPARATORParticipants received active tACS for 20 minutes followed by rehabilitation program for 12 sessions (3 days/ week, 4 weeks)
sham stimulation with rehabilitation
SHAM COMPARATORParticipants 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)
Interventions
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
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
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Physical Therapy, Mahidol University
Salaya, Changwat Nakhon Pathom, 73170, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2026
First Posted
February 25, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share