Changes in Hemodynamic Response Following Transcranial Electrical Stimulation in Sroke Individuals

February 19, 2026 updated by: Mahidol University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Changwat Nakhon Pathom
      • Salaya, Changwat Nakhon Pathom, Thailand, 73170
        • Faculty of Physical Therapy, Mahidol University
        • Contact:
        • Principal Investigator:
          • Wanalee Klomjai, PhD
        • Sub-Investigator:
          • Benchaporn Aneksan, PhD
        • Sub-Investigator:
          • Pagamas Piriyaprasarth, PhD
        • Sub-Investigator:
          • Irin Apiworajirawit, MSc
        • Sub-Investigator:
          • Pattarawan Yenrudee, BSc
        • Sub-Investigator:
          • Panot Muangpan, BSc
        • Sub-Investigator:
          • Nitchayaporn Suttipreecha, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Unilateral stroke individuals aged 18-80 years.
  2. A first-ever stroke.
  3. Stroke onset from at least 2 weeks-5 years.
  4. Able to walk independently with or without gait aids (modified Rankin scale (mRS) 1-3)
  5. Montreal cognitive Assessment-Thai version (MoCA-T) greater than or equal to 20 scores.
  6. Ability to read, communicate, follow and understand instructions.

Exclusion Criteria:

  1. 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
  2. Having unstable cardiovascular disease or respiratory disease, and uncontrolled chronic disease such as diabetes mellitus (DM), hypertension (HT) and chronic kidney disease (CKD)
  3. Receiving other non-invasive brain stimulation or additional intervention such as TMS, PMS or acupuncture
  4. Presence of metal implantation, intracranial shunt, cochlear implantation, or cardiac pacemakers.
  5. Presence of an opened wound, infectious wound around scalp or craniectomy with unreplaced bone flap
  6. Moderate pain (numeric pain rating score > 4/10) in any joint of the upper or lower limb, whether paretic or non-paretic
  7. Presence of color blindness
  8. Presence of any substance use including cannabis and kratom

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: transcranial direct current stimulation with rehabilitation
Participants received active tDCS for 20 minutes followed by rehabilitation program for 12 sessions (3 days/week, 4 weeks)
Device: Transcranial direct current stimulation
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
Other: Rehabilitation program
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
Active Comparator: transcranial alternating current stimulation with rehabilitation
Participants received active tACS for 20 minutes followed by rehabilitation program for 12 sessions (3 days/ week, 4 weeks)
Other: Rehabilitation program
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
Device: transcranial alternating current stimulation
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
Sham Comparator: sham stimulation with rehabilitation
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)
Other: Rehabilitation program
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
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, Post-intervention, 1-month follow-up and 3-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fNIRS MU-CIRB 2025/304.1106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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