Noninvasive brain stimulation plus cognitive-motor dual-task gait training to improve thinking and walking after stroke
Effects of Transcranial Electrical Stimulation (tES) Combined With Cognitive-motor Dual-task Gait Training on Cortical Activity, Spinal Motoneuron Excitability, Cognition and Motor Performance in Stroke Individuals
This trial will test whether adding high-definition noninvasive brain stimulation (tDCS or tACS) to cognitive-motor dual-task gait training and standard physical therapy helps thinking, brain activity, spinal reflexes, and walking in adults 2 weeks to 5 years after a stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Nakhon Pathom) |
| Trial ID | NCT07236216 on ClinicalTrials.gov |
What this trial studies
Adults with a first-ever unilateral stroke (2 weeks to 5 years post-onset) receive either active high-definition transcranial direct current stimulation (tDCS), active high-definition transcranial alternating current stimulation (tACS), or sham stimulation combined with conventional physical therapy and cognitive-motor dual-task gait training. The study measures cortical activity with EEG and event-related potentials, spinal motoneuron excitability via H-reflex, cognitive performance, and gait/motor outcomes before and after the intervention. Changes in physiological markers and functional performance are compared across intervention arms to determine whether adding tES yields greater improvements than training alone. All sessions are delivered in person at the Faculty of Physical Therapy, Mahidol University.
Who should consider this trial
Good fit: Ideal candidates are adults 18–80 with a first unilateral stroke 2 weeks to 5 years earlier who can walk independently (mRS 1–3), score ≥20 on the MoCA-Thai, and can read, communicate, and follow instructions.
Not a fit: Patients with severe cognitive impairment or inability to ambulate, those with epilepsy or implanted metal or electronic devices, unstable medical conditions, or uncontrolled chronic diseases are unlikely to benefit or are excluded from participation.
Why it matters
Potential benefit: If successful, this approach could improve cognition and walking while normalizing abnormal brain rhythms and spinal reflex excitability, supporting broader use of tES in stroke rehabilitation.
How similar studies have performed: Some prior tDCS studies in stroke have reported modest and variable improvements in motor and cognitive outcomes, while combining high-definition tACS with cognitive-motor dual-task gait training is less well tested and more novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nakhon Pathom
- Faculty of Physical Therapy, Mahidol University — Nakhon Pathom, Thailand (Recruiting)
Study contacts
- Study coordinator: Wanalee Klomjai, PhD
- Email: wanalee.klo@mahidol.edu
- Phone: +6624415450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.