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Brain/Neural Hand Exoskeleton Control for Restoration of Bimanual Tasks

Primary Purpose

Spinal Cord Injury, Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Brain/neural hand exoskeleton (B/NHE)
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital TuebingenRecruiting
  • Charité - University Medicine BerlinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brain/neural hand exoskeleton (B/NHE)

Arm Description

Outcomes

Primary Outcome Measures

Change in Berlin Bimanual Task Assessment (BEBITA) score

Secondary Outcome Measures

Full Information

First Posted
June 18, 2020
Last Updated
June 18, 2020
Sponsor
University Hospital Tuebingen
Collaborators
Charite University, Berlin, Germany, Reutlingen University, Hochschule der Medien, University of Stuttgart
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1. Study Identification

Unique Protocol Identification Number
NCT04440709
Brief Title
Brain/Neural Hand Exoskeleton Control for Restoration of Bimanual Tasks
Official Title
Restoration of Bimanual Activities of Daily Living Using a Brain/Neural Hand Exoskeleton (B/NHE) in Hand Paralysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
Collaborators
Charite University, Berlin, Germany, Reutlingen University, Hochschule der Medien, University of Stuttgart

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Stroke

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brain/neural hand exoskeleton (B/NHE)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Brain/neural hand exoskeleton (B/NHE)
Intervention Description
The brain/neural hand exoskeleton restores hand motor function by translating user's intention into grasping motions
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Surjo R. Soekadar, MD
Phone
+49-163-1644889
Email
surjo.soekadar@uni-tuebingen.de
Facility Information:
Facility Name
University Hospital Tuebingen
City
Tuebingen
State/Province
BW
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surjo R. Soekadar, MD
Phone
+49-163-1644889
Email
surjo.soekadar@uni-tuebingen.de
Facility Name
Charité - University Medicine Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surjo R Soekadar, MD
Phone
+49 30 450 528 153
Email
surjo.soekadar@charite.de

12. IPD Sharing Statement

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Brain/Neural Hand Exoskeleton Control for Restoration of Bimanual Tasks

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