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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: transcranial alternating current stimulation (tACS)

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.

• Study Type: Interventional
• Enrollment (Actual): 312
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: September 10, 2010
• First Submitted That Met QC Criteria: September 13, 2010
• First Posted (Estimate): September 14, 2010

Study Record Updates

• Last Update Posted (Estimate): September 14, 2010
• Last Update Submitted That Met QC Criteria: September 13, 2010
• Last Verified: October 1, 2006

More Information

Terms related to this study

• Keywords: rehabilitation; brain electrical stimulation; sub-acute post-stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2006-102