Transcranial Direct Current Stimulation in Stroke Rehabilitation

Universiteit Antwerpen34 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Stroke

Interventions

Application of Transcranial direct current stimulation (TDCS)DEVICE

Application of TDCS for 20 minutes, 4 times a week for 4 weeks.

Transcranial Direct current stimulationDEVICE

Application of true TDCS for 20min, 4 times a week for 4 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Rehabilitation Hospital Hof Ter Schelde

Antwerp, Antwerp, Belgium

RECRUITING

Outcomes

Primary Outcomes

Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two 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.

Time frame: 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)

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)

Time frame: 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)

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.

Time frame: baseline, after 1 month, After 2 months

Data from ClinicalTrials.gov

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