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Brain/Neural Hand Exoskeleton Control for Restoration of Bimanual Tasks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04440709
Recruitment Status : Unknown
Verified June 2020 by University Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : June 22, 2020
Last Update Posted : June 22, 2020
Sponsor:
Collaborators:
Charite University, Berlin, Germany
Reutlingen University
Hochschule der Medien
University of Stuttgart
Information provided by (Responsible Party):
University Hospital Tuebingen

Study Description
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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 (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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Stroke Device: Brain/neural hand exoskeleton (B/NHE) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Restoration of Bimanual Activities of Daily Living Using a Brain/Neural Hand Exoskeleton (B/NHE) in Hand Paralysis
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Brain/neural hand exoskeleton (B/NHE) Device: Brain/neural hand exoskeleton (B/NHE)
The brain/neural hand exoskeleton restores hand motor function by translating user's intention into grasping motions


Outcome Measures
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Primary Outcome Measures :
  1. Change in Berlin Bimanual Task Assessment (BEBITA) score [ Time Frame: 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. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440709


Contacts
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Contact: Surjo R. Soekadar, MD +49-163-1644889 surjo.soekadar@uni-tuebingen.de

Locations
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Germany
University Hospital Tuebingen Recruiting
Tuebingen, BW, Germany, 72076
Contact: Surjo R. Soekadar, MD    +49-163-1644889    surjo.soekadar@uni-tuebingen.de   
Charité - University Medicine Berlin Recruiting
Berlin, Germany, 10117
Contact: Surjo R Soekadar, MD    +49 30 450 528 153    surjo.soekadar@charite.de   
Sponsors and Collaborators
University Hospital Tuebingen
Charite University, Berlin, Germany
Reutlingen University
Hochschule der Medien
University of Stuttgart
More Information
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04440709    
Other Study ID Numbers: NEU007/1
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries