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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04440709
Other study ID # NEU007/1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2020
Est. completion date October 2020

Study information

Verified date June 2020
Source University Hospital Tuebingen
Contact Surjo R. Soekadar, MD
Phone +49-163-1644889
Email surjo.soekadar@uni-tuebingen.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 (EOG) for restoration of bimanual activities of daily living (ADLs). To assess bimanual ADLs, the Berlin Bimanual Task Assessment (BEBITA) will be applied. Improvements in BEBITA will be evaluated with and without B/NHE use.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date October 2020
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 68 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Brain/neural hand exoskeleton (B/NHE)
The brain/neural hand exoskeleton restores hand motor function by translating user's intention into grasping motions

Locations

Country Name City State
Germany Charité - University Medicine Berlin Berlin
Germany University Hospital Tuebingen Tuebingen BW

Sponsors (5)

Lead Sponsor Collaborator
University Hospital Tuebingen Charite University, Berlin, Germany, Hochschule der Medien, Reutlingen University, University of Stuttgart

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Berlin Bimanual Task Assessment (BEBITA) score Hand function will be assessed twice on the same day. Once before the hand exoskeleton is applied (absence of the assistive device) and once after the brain-controlled hand exoskeleton was attached to the patients' hand and arm.
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