Transcranial Direct Current Stimulation in Stroke Rehabilitation

Sponsor

Universiteit Antwerpen (Other)

Overall Status

Unknown status

CT.gov ID

NCT01356654

Collaborator

Rehabilitation Hospital Hof Ter Schelde (Other), Artesis University College, Antwerp (Other)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Application of Transcranial direct current stimulation (TDCS) Device: Transcranial Direct current stimulation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2011

Anticipated Study Completion Date :

Jun 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months) [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.
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) [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)
Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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