Clinical trial NCT01200719: Transcranial Alternating Current Stimulation
Official title: Transcranial Alternating Current Stimulation (tACS) Enhances Neurological Function Recovery Among Post-stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Keywords: brain electrical stimulation
sub-acute post-stroke
rehabilitation
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
First posted: 2010-09-14
Enrollment: 312
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: NIH Stroke Scale (NIHSS) score
timeFrame: 3 weeks
Secondary outcomes:
measure: the mean blood flow velocity (MFV)
timeFrame: 30 minutes
measure: Gosling pulsatility index (PI)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
affiliation: Rehabilitation Center, Huashan Hospital of Fudan University, Shanghai, China
name: Yongshan Hu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Rehabilitation Science, the Hong Kong Polytechnic University
name: Chetwyn Chan, PhD
role: STUDY_DIRECTOR
References: