Transcranial Alternating Current Stimulation
|ClinicalTrials.gov Identifier: NCT01200719|
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : September 14, 2010
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: transcranial alternating current stimulation (tACS)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||312 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Transcranial Alternating Current Stimulation (tACS) Enhances Neurological Function Recovery Among Post-stroke Patients|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||September 2009|
|Experimental: tACS group||
Device: transcranial alternating current stimulation (tACS)
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.
Other Name: CVFT-MG201(China Patent No. ZL98121951.9)
No Intervention: Control group
Patients in the control group followed exactly the same protocol but without receiving the transcranial alternating current stimulation .
- NIH Stroke Scale (NIHSS) score [ Time Frame: 3 weeks ]
- the mean blood flow velocity (MFV) [ Time Frame: 30 minutes ]captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler
- Gosling pulsatility index (PI) [ Time Frame: 30 minutes ]captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200719
|Shanghai, Shanghai, China, 200040|
|Principal Investigator:||Yongshan Hu, MD||Rehabilitation Center, Huashan Hospital of Fudan University, Shanghai, China|
|Study Director:||Chetwyn Chan, PhD||Department of Rehabilitation Science, the Hong Kong Polytechnic University|