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Completed

NCT Number: NCT01200719

Transcranial Alternating Current Stimulation

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

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Key information

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CVFT-MG201(China Patent No. ZL98121951.9)

Primary outcomes

  1. NIH Stroke Scale (NIHSS) score

    Time frame: 3 weeks

Secondary outcomes

  1. the mean blood flow velocity (MFV)

    Time frame: 30 minutes

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

  2. Gosling pulsatility index (PI)

    Time frame: 30 minutes

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

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • The Hong Kong Polytechnic University

Registry information

Official study title

Transcranial Alternating Current Stimulation (tACS) Enhances Neurological Function Recovery Among Post-stroke Patients

Important dates

Study start
2006
Primary completion
2007
Study completion
2009
First posted
Sep 14, 2010
Registry last updated
Sep 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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