Transcranial Direct Current Stimulation in Stroke Rehabilitation

May 18, 2011 updated by: Universiteit Antwerpen

The Use of Transcranial Direct Current Stimulation in the Recovery of Postural Control in Stroke

This study investigates if transcranial Direct Current Stimulation (tDCS) is effective in the recovery of postural control in stroke rehabilitation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The patients were divided in 2 groups by a randomisation procedure. All patients participated for 2 months in the study. Group 1 received true tDCS in the first month followed by SHAM stimulation in the second month. Group 2 received SHAM in the first month and true stimulation in the following month. Four stimulations of 20minutes were provided during 4 weeks before before changing stimulation intensity.

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2050
        • Recruiting
        • Rehabilitation Hospital Hof Ter Schelde
        • Contact:
        • Principal Investigator:
          • Wim Saeys, Msc
        • Sub-Investigator:
          • Luc Vereeck, PhD
        • Sub-Investigator:
          • Christophe Lafosse, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients suffering from the consequences of a stroke in the medial cerebral artery, during the sub-acute phase (4-24 weeks after onset)
  2. Age between 18-75 years
  3. Hospitalised in rehabilitation Hospital Hof Ter Schelde
  4. Capable of understanding and giving informed consent

Exclusion Criteria:

  1. Cerebellum or brainstem lesions
  2. Recently multiple lesions and older lesions which are manifested clinically.
  3. History of severe substance abuse (alcohol, drugs, benzodiazepines)
  4. Cardiac disease that in the opinion of the clinician precludes participation in the trial (severe dyspnea in rest, severe rhythm disturbances, etc)
  5. History of epileptic insults, not caused by the stroke
  6. Severe organic co morbidity
  7. Psychiatric disorders or history of psychiatric disorders
  8. Pace maker / internal defibrillator
  9. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: SHAM TDCS
Device: Application of Transcranial direct current stimulation (TDCS)
Application of TDCS for 20 minutes, 4 times a week for 4 weeks.
Other Names:
  • tDCS device: CESta, Mind Alive Inc.,Edmonton, Alberta, Canada
Active Comparator: True TDCS
Device: Transcranial Direct current stimulation
Application of true TDCS for 20min, 4 times a week for 4 weeks.
Other Names:
  • tDCS device: CESta, Mind Alive Inc., Edmonton, Alberta, Canada

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months)
Time Frame: baseline, after 1 month, After 2 months
The static sitting balance subscale assesses whether a subject can sit independently and remain seated when the legs are either passively or actively crossed. The dynamic sitting balance subscale evaluates the ability to actively shorten each side of the trunk, first initiated from the shoulder and subsequently initiated from the pelvic girdle. Trunk coordination is evaluated by the possibility to independently rotate the upper and lower part of the trunk. The scoring range for the static and dynamic sitting balance and coordination subscales are 7, 10 and 6 points respectively.
baseline, after 1 month, After 2 months
Rivermead Motor Assessment Battery (RMAB) (reporting a change on motricity of gross function, arm, leg and trunk at baseline, after 1 month and after two months)
Time Frame: baseline, after 1 month, After 2 months
The RMAB assesses the motor performance of patients with stroke.32 It consists of test items clustered in three sections that are ordered hierarchically. The gross function subscale (13 items), the Leg and Trunk subscale (10 items) and the arm subscale (15 items)
baseline, after 1 month, After 2 months
Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months)
Time Frame: baseline, after 1 month, After 2 months

The Tinetti Test is an easily performed test that measures a patients' gait and balance. The individual scores are combined to form three measures; a gait score, a standing balance score and a total score.

The maximum score for the gait component and the balance component are 12 and 16 points respectively, resulting in a maximum of 28 points for the total score.
baseline, after 1 month, After 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Antwerpen

Collaborators

Artesis University College, Antwerp
Rehabilitation Hospital Hof Ter Schelde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (Estimate)

May 19, 2011

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Saeys-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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