Status:
UNKNOWN
Brain/Neural Hand Exoskeleton Control for Restoration of Bimanual Tasks
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Charite University, Berlin, Germany
Reutlingen University
Conditions:
Spinal Cord Injury
Stroke
Eligibility:
All Genders
18-68 years
Phase:
NA
Brief Summary
This study investigates whether spinal cord injury and stroke survivors (n=10) are able to operate a brain/neural hand exoskeleton (B/NHE) based on electroencephalography (EEG) and electrooculography ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Stroke):
- single ischemic or hemorrhagic insult with subcortical lesion (medullary canal, internal capsula, pedunculi cerebri)
- interval since stroke at least 6 months
- substantial motor deficit with:
- Medical Research Council (MRC) -score of less than 2 out of 6 possible points (0=no activity; 1=visible contraction without motor effect; 2=movements with elimination of gravity; 3=movements against gravity; 4=movements against weak resistance; 5=normal force)
- Fugl-Meyer Test (upper extremity) of less than 31 points, "no to little mobility"
- Inclusion Criteria (Spinal Cord Injury):
- cervical spinal cord injury, height C5-C6
- interval after spinal cord injury at least 6 months
- substantial motor deficit with American Spinal Cord Association (ASIA) -Classification B or C (A=no muscle function/sensitivity below the spinal cord injury; B=no muscle function, limited sensitivity present; C=low non-relevant muscle function, sensitivity present; D=functionally relevant muscle functions present; E=fully preserved or restored functions)
- Exclusion Criteria (Stroke and Spinal Cord Injury):
- Alcohol or drug problem (regular consumption of more than 2 alcoholic beverages per day, or taking illegal drugs)
- currently undergoing neurological or psychiatric treatment based on a secondary diagnosis
- Severe and uncontrollable medical problems:
- Non-adjusted malignant high blood pressure, World Health Organization (WHO) Hypertension Grade II
- non-adjustable diabetes mellitus, HbA1c \> 58 mmol/mol
- renal failure, from KDIGO glomerular filtration rate (GFR) category G3b (moderate to severe impairment)
- Liver failure, Child-Pugh stages B and C
- Heart failure New York Heart Association (NYHA) grade III-IV
- malignant tumor disease
- severe arrhythmia in need of treatment
- severe oedemas
- severe arthritis
- serious cognitive impairment (minimum status below 23 points)
- Severe spasticity (Ashworth grade ≥ 4)
- Pregnancy
- Bilateral motor deficit (in stroke patients)
Exclusion
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04440709
Start Date
June 1 2020
End Date
October 1 2020
Last Update
June 22 2020
Active Locations (2)
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1
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany, 72076
2
Charité - University Medicine Berlin
Berlin, Germany, 10117