Rehabilitation after stroke improves motor functions by promoting plastic changes however, after completing standard rehabilitation, 50-60% of patients still exhibit some degree of motor impairment and require at least partial assistance in activities of day living. Therefore, the exploration of other approaches to promote recovery is compulsory. Non invasive brain stimulation and motor rehabilitation are thought to share similar mechanisms in inducing neuroplastic changes in the human cortex and an emerging field of research is focusing on the possibility of coupling both therapies in order to achieve an additive effect and improve outcome. We hypothesize that coupling bihemispheric transcranial direct current stimulation (tDCS) with simultaneous physical/occupational therapy in the subacute phase of ischemic stroke patients may improve upper limb motor recovery in humans. This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial. Thirty-six ischemic stroke patients in the subacute phase will be recruited in three centers of neurorehabilitation in Switzerland. After stratification based on the Fugl-Meyer Assessment Upper Extremity according to the severity of the deficit, the patient will be randomized to receive besides standardized physical/occupational treatment according to the Impairment-Oriented Training, tDCS of themotor cortex (1.5 mA, 30 minutes) (group 1: 12 patients) or sham stimulation (without current) (group 2: 12 patients). After three weeks of treatment group 1 and 2 will cross-over and will be treated for other three weeks. Group 3 (12 patients) will receive routine physical/occupational treatment and sham tDCS for six weeks. Assessment will be performed before starting tDCS, at week 3, 6 and at 6 months. Outcome measures are the Fugl-Meyer Assessment Upper Extremity, the extended Barthel Index, the Ashworth scale, the Test of Upper Limb Apraxia (only baseline, week 6, month6), the grip strength evaluated by the Jamar Hydraulic Hand dynamometer. At baseline at week 6 and at month 6 depression will be assessed by the Hamilton depression Rating Scale.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
36
Anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks, then sham stimulation for 30 seconds on 15 days during 3 weeks
Sham stimulation for 30 seconds on 15 days during 3 weeks, then anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks
Sham stimulation for 30 seconds on 15 days during 6 weeks
Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation
Bern, Switzerland
WITHDRAWNClinica Hildebrand, Centro di riabilitazione Brissago
Brissago, Switzerland
RECRUITINGHELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum
Zihlschlacht, Switzerland
TERMINATEDFugl-Meyer Assessment Upper Extremity
Investigator administered questionnaire
Time frame: 6 weeks
Fugl-Meyer Assessment Upper Extremity
Investigator administered questionnaire
Time frame: 3 weeks
Fugl-Meyer Assessment Upper Extremity
Investigator administered questionnaire
Time frame: 6 months
Barthel Index
Investigator administered questionnaire
Time frame: 3 weeks
Barthel Index
Investigator administered questionnaire
Time frame: 6 weeks
Barthel Index
Investigator administered questionnaire
Time frame: 6 months
Ashworth scale
Investigator administered questionnaire
Time frame: 3 weeks
Ashworth scale
Investigator administered questionnaire
Time frame: 6 weeks
Ashworth scale
Investigator administered questionnaire
Time frame: 6 months
Test of Upper Limb Apraxia (TULIA)
investigator administered questionnaire
Time frame: 6 weeks
Test of Upper Limb Apraxia (TULIA)
investigator administered questionnaire
Time frame: 6 months
Grip strength
Jamar Hydraulic Hand dynamometer
Time frame: 3 weeks
Grip strength
Jamar Hydraulic Hand dynamometer
Time frame: 6 weeks
Grip strength
Jamar Hydraulic Hand dynamometer
Time frame: 6 months
Hamilton depression Rating scale
Patient administered questionnaire
Time frame: 6 weeks
Hamilton depression Rating scale
Patient administered questionnaire
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.