Transcranial Alternating Current Stimulation

This study has been completed.
Sponsor:
Collaborator:
The Hong Kong Polytechnic University
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01200719
First received: September 10, 2010
Last updated: September 13, 2010
Last verified: October 2006

September 10, 2010
September 13, 2010
November 2006
June 2007   (final data collection date for primary outcome measure)
NIH Stroke Scale (NIHSS) score [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01200719 on ClinicalTrials.gov Archive Site
  • the mean blood flow velocity (MFV) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler
  • Gosling pulsatility index (PI) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler
Same as current
Not Provided
Not Provided
 
Transcranial Alternating Current Stimulation
Transcranial Alternating Current Stimulation (tACS) Enhances Neurological Function Recovery Among Post-stroke Patients

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
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)
  • Experimental: tACS group
    Intervention: Device: transcranial alternating current stimulation (tACS)
  • No Intervention: Control group
    Patients in the control group followed exactly the same protocol but without receiving the transcranial alternating current stimulation .
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
312
September 2009
June 2007   (final data collection date for primary outcome measure)

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
Both
40 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01200719
2006-102
Yes
Yongshan Hu, Head of Rehabilitation Center, Huashan Hospital of Fudan University
Fudan University
The Hong Kong Polytechnic University
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
Fudan University
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP