Transcranial Alternating Current Stimulation

Phase 4

Completed

• Conditions: Stroke
• Interventions: Device: transcranial alternating current stimulation (tACS)

• Registration Number: NCT01200719
• Lead Sponsor: Fudan University

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.

Study Timeline

• Status Verified: 2006-10
• Study Start: 2006-11
• Primary Completion: 2007-06
• Study Completion: 2009-09
• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-09-13
• Last Update Submitted: 2010-09-13
• Study First Posted: 2010-09-14
• Last Update Posted: 2010-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tACS group	transcranial alternating current stimulation (tACS)	-

Primary Outcome Measures

Name	Time	Method
NIH Stroke Scale (NIHSS) score	3 weeks

Secondary Outcome Measures

Name	Time	Method
the mean blood flow velocity (MFV)	30 minutes	captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler
Gosling pulsatility index (PI)	30 minutes	captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China