Changes in Hemodynamic Response Following Transcranial Electrical Stimulation in Sroke Individuals
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMahidol University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Factorial
Treatments tested in this trial
Transcranial direct current stimulation
DeviceThe 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
DeviceThe 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 interventionConventional 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)
DeviceThe 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
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: transcranial direct current stimulation with rehabilitationActive comparator 2 interventions
Group B: transcranial alternating current stimulation with rehabilitationActive comparator 2 interventions
Group C: sham stimulation with rehabilitationSham comparator 2 interventions
Trial outcomes
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)
Time frame
Baseline, Post-intervention, 1-month follow-up and 3-month follow-upSponsors and contacts
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Source ClinicalTrials.gov