Clinical trial NCT01356654: Transcranial Direct Current Stimulation in Stroke Rehabilitation
Official title: The Use of Transcranial Direct Current Stimulation in the Recovery of Postural Control in Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
TDCS
Gait
Balance
loss of postural balance
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Rehabilitation Hospital Hof Ter Schelde
name: Artesis University College, Antwerp
First posted: 2011-05-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months)
timeFrame: baseline, after 1 month, After 2 months
measure: 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)
timeFrame: baseline, after 1 month, After 2 months
measure: Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months)
timeFrame: baseline, after 1 month, After 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Rehabilitation Hospital Hof Ter Schelde
Study officials:
References:
citation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.