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Transcranial Alternating Current Stimulation

Primary Purpose

Stroke

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
transcranial alternating current stimulation (tACS)
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring brain electrical stimulation, sub-acute post-stroke, rehabilitation

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Huashan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

tACS group

Control group

Arm Description

Patients in the control group followed exactly the same protocol but without receiving the transcranial alternating current stimulation .

Outcomes

Primary Outcome Measures

NIH Stroke Scale (NIHSS) score

Secondary Outcome Measures

the mean blood flow velocity (MFV)
captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler
Gosling pulsatility index (PI)
captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler

Full Information

First Posted
September 10, 2010
Last Updated
September 13, 2010
Sponsor
Fudan University
Collaborators
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT01200719
Brief Title
Transcranial Alternating Current Stimulation
Official Title
Transcranial Alternating Current Stimulation (tACS) Enhances Neurological Function Recovery Among Post-stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University
Collaborators
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
brain electrical stimulation, sub-acute post-stroke, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tACS group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in the control group followed exactly the same protocol but without receiving the transcranial alternating current stimulation .
Intervention Type
Device
Intervention Name(s)
transcranial alternating current stimulation (tACS)
Other Intervention Name(s)
CVFT-MG201(China Patent No. ZL98121951.9)
Intervention Description
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.
Primary Outcome Measure Information:
Title
NIH Stroke Scale (NIHSS) score
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
the mean blood flow velocity (MFV)
Description
captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler
Time Frame
30 minutes
Title
Gosling pulsatility index (PI)
Description
captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongshan Hu, MD
Organizational Affiliation
Rehabilitation Center, Huashan Hospital of Fudan University, Shanghai, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chetwyn Chan, PhD
Organizational Affiliation
Department of Rehabilitation Science, the Hong Kong Polytechnic University
Official's Role
Study Director
Facility Information:
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China

12. IPD Sharing Statement

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Transcranial Alternating Current Stimulation

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