Transcranial Direct Current Stimulation in Stroke Rehabilitation

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01356654
• Other study ID #: Saeys-1
• Status: Recruiting
• Phase: N/A
• First received: May 10, 2011
• Last updated: May 18, 2011
• Start date: March 2010
• Est. completion date: June 2011

Study information

• Verified date: May 2011
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Application of Transcranial direct current stimulation (TDCS)
Application of TDCS for 20 minutes, 4 times a week for 4 weeks.
• Transcranial Direct current stimulation
Application of true TDCS for 20min, 4 times a week for 4 weeks.

Locations

Country	Name	City	State
Belgium	Rehabilitation Hospital Hof Ter Schelde	Antwerp

Sponsors (3)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Artesis University College, Antwerp, Rehabilitation Hospital Hof Ter Schelde

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, after 1 month, After 2 months	No
Primary	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)	baseline, after 1 month, After 2 months	No
Primary	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.	baseline, after 1 month, After 2 months	No