Brain-computer interface and neuromuscular stimulation for rehabilitation following sub-acute stroke

Not Applicable

Recruiting

Conditions: I61
I63
Intracerebral haemorrhage
Cerebral infarction

Registration Number: DRKS00011522

Lead Sponsor: niversitätsklinik für Neurologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

First stroke (thrombotic or haemorrhagic), diagnosed with CT or MRI, lasting 4 weeks to 6 months
- Reduced or absent power of the affected extremity (arm/hand)

Exclusion Criteria

- sever aphasia
- Medical Research Council Power Test: >= 3
- cognitive impairment leading to inability to perform the tasks: Montreal Cognitive Assessment (> 25)
- severe depression
- medically unstable (postural hypotension, sepsis, epilepsy, severe renal failure, hemispatial neglect, severe visual impairment, fixed joint contractures, skin condition which could be worsened by electrode placement)
- certain medications (L-dopa, amantadine. Antidepressive medication is permissible.)
- history of epilepsy
- Fatigue Severity Scale: > 36/63
- Pain Scale: > 5/10

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of mobility, to enable performance of daily tasks. To be evaluated and quantified using the Fugl-Mayr Assessment: motor arm.<br><br>The test will be carried out before the therapy, at the end of each week of therapy, and 6 months after the therapie.

Secondary Outcome Measures

Name	Time	Method
The following tests will be carried out before the therapy, after 3 and 5 weeks, and 6 months after the therapy:<br>- Medical Research Council Power Test<br>- Rivermead Test<br>- Barthel Index<br>- National Institute of Health Stroke Scale (motor: Arm)<br>- European Stroke Scale<br>- Modified Ashworth Scale (spasticity)<br>- Sensory deficits (Since feedback is visual as well as sensory, these patients will be included. Baseline 2-point discrimination and proprioceptive tests will be performed.)<br>- Standard clinical evaluation of the cranial and peripheral nerves, gait, Romberg test<br>- Neuropsychological profile (with Montreal Cognitive Assessment)<br>- Goal attainment questionnaire<br>- Stroke Impact Scale