Transcranial Alternating Current Stimulation

Study Overview
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Brief Summary
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To investigate the efficacy of using transcranial alternating current stimulation (tACS) to enhance the regaining of neurological function among post-stroke patients.

Detailed Description
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Sixty post-stroke patients were randomly assigned to receive 15 sessions of the usual rehabilitation programme with or without tACS. The NIH Stroke Scale (NIHSS) and the mean blood flow velocity (MFV) and Gosling pulsatility index (PI) captured for the middle, anterior, and posterior cerebral artery were the outcome measures. Fifteen 30-minute sessions of tACS appear to be effective for enhancing post-stroke patients' neurological function. The haemodynamic measures taken indicated that the regaining of function among the patients was largely attributed to a lowering of the vascular autoregulatory activity together with an increase in blood flow velocity at the middle cerebral artery. Future studies should explore the underlying mechanisms mediating the positive effects brought about by tACS in post-stroke rehabilitation.

Official Title
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Transcranial Alternating Current Stimulation (tACS) Enhances Neurological Function Recovery Among Post-stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Device: transcranial alternating current stimulation (tACS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed as first onset intracerebral haemorrhage or infarction (according to ICD-10 I61.0-I61.6 or I63.3-I63.6, with or without I69, i.e.: sequelae of cerebrovascular disease) between 15 and 60 days after the onset right handedness no previous neurological or psychiatric disorders positive transtemporal windows for bilateral middle, anterior, and posterior cerebral arteries insonation (according to the standards set by the Transcranial Doppler Ultrasonographic Device (TCD)) NIH Stroke Scale (NIHSS) scores between 14 and 24 not receiving rehabilitation before admission Exclusion Criteria: medical comorbidity preventing the patient undergoing the intervention preceding epileptic fits having metallic implants in the brain or a pacemaker history of surgery to the brain

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tACS group<br> | Device: transcranial alternating current stimulation (tACS)<br>* Patients in the tACS group received a total of 15 sessions of brain stimulation. The sessions were conducted on weekdays (from Monday to Friday) for three consecutive weeks. Each session lasted 30 minutes. The alternating current stimulations were generated by a CVFT-MG201 machine. Stimulations were delivered by two U-shaped electrodes (approximately 7 cm2) fixed on the patient's left and right mastoid regions (anode or cathode varied depending on polarity of the alternating current). The frequencies (supra-slow waves: < 1 Hz; theta to gamma), levels of intensities (0 to 3mA), and density function (follows a bell-shaped curve; mean intensity   2.1mA) of the current were delivered according to the manufacturer's pre-set random protocol.<br>* Other names: CVFT-MG201(China Patent No. ZL98121951.9);|
| No Intervention: Control group<br>Patients in the control group followed exactly the same protocol but without receiving the transcranial alternating current stimulation . | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH Stroke Scale (NIHSS) score |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean blood flow velocity (MFV) | captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler | 30 minutes | 
| Gosling pulsatility index (PI) | captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain electrical stimulation, sub-acute post-stroke, rehabilitation