Transcranial Direct Current Stimulation in Stroke Rehabilitation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Universiteit Antwerpen.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Rehabilitation Hospital Hof Ter Schelde
Artesis University College, Antwerp
Information provided by:
Universiteit Antwerpen
ClinicalTrials.gov Identifier:
NCT01356654
First received: May 10, 2011
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention
Stroke
Device: Application of Transcranial direct current stimulation (TDCS)
Device: Transcranial Direct current stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Transcranial Direct Current Stimulation in the Recovery of Postural Control in Stroke

Resource links provided by NLM:


Further study details as provided by Universiteit Antwerpen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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)

  • 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 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 34
Study Start Date: March 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: tDCS device: CESta, Mind Alive Inc., Edmonton, Alberta, Canada

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356654

Locations
Belgium
Rehabilitation Hospital Hof Ter Schelde Recruiting
Antwerp, Belgium, 2050
Contact: Wim Saeys, MSc    032106020    wim.saeys@hotmail.com   
Principal Investigator: Wim Saeys, Msc         
Sub-Investigator: Luc Vereeck, PhD         
Sub-Investigator: Christophe Lafosse, PhD         
Sponsors and Collaborators
Universiteit Antwerpen
Rehabilitation Hospital Hof Ter Schelde
Artesis University College, Antwerp
  More Information

No publications provided

Responsible Party: Msc Wim Saeys, UZA
ClinicalTrials.gov Identifier: NCT01356654     History of Changes
Other Study ID Numbers: Saeys-1
Study First Received: May 10, 2011
Last Updated: May 18, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by Universiteit Antwerpen:
Stroke
TDCS
Gait
Balance
loss of postural balance

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 28, 2014