NCT01200719

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P50-P75 for phase_4 stroke

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 10, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
Last Updated

September 14, 2010

Status Verified

October 1, 2006

Enrollment Period

7 months

First QC Date

September 10, 2010

Last Update Submit

September 13, 2010

Conditions

Stroke

Keywords

brain electrical stimulationsub-acute post-strokerehabilitation

Outcome Measures

Primary Outcomes (1)

  • NIH Stroke Scale (NIHSS) score

    3 weeks

Secondary Outcomes (2)

  • the mean blood flow velocity (MFV)

    30 minutes

  • Gosling pulsatility index (PI)

    30 minutes

Study Arms (2)

tACS group

EXPERIMENTAL
Device: transcranial alternating current stimulation (tACS)

Control group

NO INTERVENTION

Patients in the control group followed exactly the same protocol but without receiving the transcranial alternating current stimulation .

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.

Also known as: CVFT-MG201(China Patent No. ZL98121951.9)
tACS group

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Yongshan Hu, MD

    Rehabilitation Center, Huashan Hospital of Fudan University, Shanghai, China

    PRINCIPAL INVESTIGATOR

  • Chetwyn Chan, PhD

    Department of Rehabilitation Science, the Hong Kong Polytechnic University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2010

First Posted

September 14, 2010

Study Start

November 1, 2006

Primary Completion

June 1, 2007

Study Completion

September 1, 2009

Last Updated

September 14, 2010

Record last verified: 2006-10

Locations

CN(1)