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
  Purpose

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


Condition Intervention Phase
Stroke
Device: transcranial alternating current stimulation (tACS)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Alternating Current Stimulation (tACS) Enhances Neurological Function Recovery Among Post-stroke Patients

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • NIH Stroke Scale (NIHSS) score [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 312
Study Start Date: November 2006
Study Completion Date: September 2009
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 .

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200719

Locations
China, Shanghai
Huashan Hospital
Shanghai, Shanghai, China, 200040
Sponsors and Collaborators
Fudan University
The Hong Kong Polytechnic University
Investigators
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
  More Information

No publications provided

Responsible Party: Yongshan Hu, Head of Rehabilitation Center, Huashan Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT01200719     History of Changes
Other Study ID Numbers: 2006-102
Study First Received: September 10, 2010
Last Updated: September 13, 2010
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
brain electrical stimulation
sub-acute post-stroke
rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 20, 2014