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RECRUITING Not applicable ClinicalTrials.gov

Changes in Hemodynamic Response Following Transcranial Electrical Stimulation in Sroke Individuals

Sponsor: Mahidol University • ClinicalTrials.gov ID: NCT07433972

Registry updated: 2026-10-08
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Description

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.

Interventions

  • Transcranial direct current stimulation (Device)
    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 stimulation (Device)
    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 program (Other)
    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

Eligibility 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

Conditions

Hemorrhagic Stroke Ischemic Stroke Subacute Stroke Chronic Stroke Survivors

Locations

  • Faculty of Physical Therapy, Mahidol University — Salaya, Changwat Nakhon Pathom, Thailand
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record