Transcranial Direct Current Stimulation (tDCS) of the Lesioned or Non-lesioned Hemisphere Plus Computer-assisted Arm Trainer: a Randomized, Placebo-controlled Double-blind Multi-centre Study in Patients With Severe Arm Paresis Early After Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 96
- Locations
- 3
- Primary Endpoint
- Fugl-Meyer Upper Limb Motor Score (0-66)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
Transcranial galvanic stimulation (tDCS) seems to promote motor recovery after stroke by stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment of severe arm paresis after stroke, robot-assisted arm training (AT) proved to be effective, but nevertheless only a few patients could use their affected hand functionally in daily life after robot training. Therefore the present study intends to combine both approaches, tDCS + AT, applied at the same time every day for six weeks. The study has three treatment arms, two groups will receive the tDCS, either anodal of the lesioned or cathodal of the non-lesioned hemisphere. The anodal stimulation is expected to facilitate the activity of the arm motor area of the lesioned side directly, while the cathodal stimulation of the non-lesioned hemisphere is expected to facilitate the lesioned side indirectly by decreasing inhibitory inputs. The third group will receive a sham-stimulation. All patients will work with the AT simultaneously to the tDCS, respectively sham-tDCS.
Investigators
Eligibility Criteria
Inclusion Criteria
- •subacute stroke
- •stroke interval 3 to 8 weeks
- •severe upper limb paresis
- •Fugl-Meyer \< 18
Exclusion Criteria
- •history of epilepsy
- •antiepileptic, neuroleptic medication
- •metal implants
Outcomes
Primary Outcomes
Fugl-Meyer Upper Limb Motor Score (0-66)
Time Frame: 45 min
Secondary Outcomes
- Box&Block Test(5 min)