Transcranial Alternating Current Stimulation

Phase 4CompletedNCT01200719

Fudan University312 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

312

Conditions

Stroke

Interventions

transcranial alternating current stimulation (tACS)DEVICE

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (1)

Huashan Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

NIH Stroke Scale (NIHSS) score

Time frame: 3 weeks

Secondary Outcomes

the mean blood flow velocity (MFV)

captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler

Time frame: 30 minutes

Gosling pulsatility index (PI)

captured for the middle, anterior, and posterior cerebral artery by transcranial Doppler

Time frame: 30 minutes

Data from ClinicalTrials.gov

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