Effects of tES Combined With CMDT Gait Training on Cognition, Cortical Activity, Spinal Motoneuron Excitability and Motor Performance in Stroke Individuals

NCT07236216 | Recruiting

• 1 other identifier: MU-CIRB 2025/304.1106
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 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 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.

Conditions

Hemorrhagic Stroke; Ischemic Stroke; Subacute Stroke; Chronic Stroke Patient

Keywords

stroke; electroencephalography; event related potentials; rehabilitation; gait training; High-definition transcranial electrical stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1-day post-intervention, 1-month follow-up, and 3-month follow-up

Secondary Outcomes (7)

• Event Related Potential (ERP)

  Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up

• Absolute power

  Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up

• Montreal Cognitive Assessment

  Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up

• Timed up and go test

  Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up

• Cognitive-motor interference (CMI)

  Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up

Study Arms (3)

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).

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).

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).

Device: High-definition transcranial electrical stimulation (sham); Other: Cognitive-motor dual task gait training; Other: Conventional Physical therapy

Interventions

High-definition transcranial electrical stimulation (sham) DEVICE

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.

Also known as: Sham stimulation, starstim; Neuroelectrics, Spian

Sham stimulation witn conventional physical therapy and CMDT gait training

High-definition transcranial direct current stimulation (Active) DEVICE

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.

Also known as: HD-tDCS, starstim; Neuroelectrics, Spain

Active HD-tDCS with conventional physical therapy and CMDT gait training

High-definition transcranial alternating stimulation (Active) DEVICE

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.

Also known as: HD-tACS, starstim; Neuroelectrics, Spian

Active HD-tACS with conventional physical therapy and CMDT gait training

Cognitive-motor dual task gait training OTHER

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.

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 therapy OTHER

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.

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Nakhon Pathom, 73170, Thailand

RECRUITING

MeSH Terms

Conditions

Hemorrhagic Stroke; Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Wanalee Klomjai, PhD

CONTACT

+6624415450; wanalee.klo@mahidol.edu

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: September 24, 2025
• First Posted: November 19, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)