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Daily-life Brain Control Of A Hand Exoskeleton After Cervical Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
BNCI controlled hand exoskeleton
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

15 Years - 65 Years (Child, Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

  • American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B & C (Lower Extremity Motor Score <20)
  • Motor level of injury from cervical level 4 to cervical level 7, according to ASIA guidelines
  • Male and non-pregnant, non-lactating female
  • Age 15-65 years old
  • At least 12 months after injury

Exclusion Criteria:

  • History of severe neurological injuries other than spinal cord injury (e.g. Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)
  • Concurrent medical diseases (eg. infections, circulatory, heart or lung, pressure sores) interfering with the study
  • Unstable spine or unhealed limbs or pelvic fractures
  • Severe spasticity (Ashworth grade 4; ie. Affected part(s) rigid in flexion or extension) or uncontrolled clonus
  • Diagnosis of severe osteoporosis/penia as proven with pQCT or DXA.
  • Psychiatric or cognitive conditions that may interfere with the trial
  • Patients incapable of providing informed consent

Sites / Locations

  • Instituto Guttmann, Hospital de Neurorehabilitació

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BNCI hand-exoskeleton

Arm Description

Hand motor function before, during and after application of the device

Outcomes

Primary Outcome Measures

Change of Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) Score
The TRI-HFT will be applied once before and while the patients wear the hand exoskeleton

Secondary Outcome Measures

Full Information

First Posted
December 19, 2014
Last Updated
May 13, 2015
Sponsor
University Hospital Tuebingen
Collaborators
Institut Guttmann, Scuola Superiore Sant'Anna di Studi Universitari e di Perfezionamento
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1. Study Identification

Unique Protocol Identification Number
NCT02336321
Brief Title
Daily-life Brain Control Of A Hand Exoskeleton After Cervical Spinal Cord Injury
Official Title
Restoration of Daily-life Hand Function Using a Brain/Neural-Computer Interaction (BNCI) System in Paralysis After Cervical Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
Collaborators
Institut Guttmann, Scuola Superiore Sant'Anna di Studi Universitari e di Perfezionamento

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, 6 volunteer participants with chronic spinal cord injury will be invited to use an autonomous hand exoskeleton device controlled by a brain/neural-computer interaction (BNCI) system fusing electroencephalography (EEG) and electrooculography (EOG) to detect the intention of the user to grasp objects of daily life. The BNCI system consists of a lightweight hand exoskeleton connected to portable motors, rechargeable batteries and a computerized control system integrated into a wheelchair. Before, during and after use of the BNCI system the volunteers will perform standardized assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. Functional outcomes primarily focus on motor function in performing daily life actions while psychological outcomes primarily focus on safety, reliability as well as predisposition and perceptions of disability.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BNCI hand-exoskeleton
Arm Type
Experimental
Arm Description
Hand motor function before, during and after application of the device
Intervention Type
Device
Intervention Name(s)
BNCI controlled hand exoskeleton
Intervention Description
The BNCI system fuses and translates bio-signals related to user intention into control signals of an assistive device performing grasping motions
Primary Outcome Measure Information:
Title
Change of Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) Score
Description
The TRI-HFT will be applied once before and while the patients wear the hand exoskeleton
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

Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B & C (Lower Extremity Motor Score <20) Motor level of injury from cervical level 4 to cervical level 7, according to ASIA guidelines Male and non-pregnant, non-lactating female Age 15-65 years old At least 12 months after injury Exclusion Criteria: History of severe neurological injuries other than spinal cord injury (e.g. Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke) Concurrent medical diseases (eg. infections, circulatory, heart or lung, pressure sores) interfering with the study Unstable spine or unhealed limbs or pelvic fractures Severe spasticity (Ashworth grade 4; ie. Affected part(s) rigid in flexion or extension) or uncontrolled clonus Diagnosis of severe osteoporosis/penia as proven with pQCT or DXA. Psychiatric or cognitive conditions that may interfere with the trial Patients incapable of providing informed consent
Facility Information:
Facility Name
Instituto Guttmann, Hospital de Neurorehabilitació
City
Badalona
State/Province
Catalonia
ZIP/Postal Code
08916
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25490027
Citation
Soekadar SR, Witkowski M, Vitiello N, Birbaumer N. An EEG/EOG-based hybrid brain-neural computer interaction (BNCI) system to control an exoskeleton for the paralyzed hand. Biomed Tech (Berl). 2015 Jun;60(3):199-205. doi: 10.1515/bmt-2014-0126.
Results Reference
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PubMed Identifier
25510922
Citation
Witkowski M, Cortese M, Cempini M, Mellinger J, Vitiello N, Soekadar SR. Enhancing brain-machine interface (BMI) control of a hand exoskeleton using electrooculography (EOG). J Neuroeng Rehabil. 2014 Dec 16;11:165. doi: 10.1186/1743-0003-11-165.
Results Reference
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PubMed Identifier
24187233
Citation
Cempini M, De Rossi SM, Lenzi T, Cortese M, Giovacchini F, Vitiello N, Carrozza MC. Kinematics and design of a portable and wearable exoskeleton for hand rehabilitation. IEEE Int Conf Rehabil Robot. 2013 Jun;2013:6650414. doi: 10.1109/ICORR.2013.6650414.
Results Reference
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PubMed Identifier
25326697
Citation
Cempini M, Marzegan A, Rabuffetti M, Cortese M, Vitiello N, Ferrarin M. Analysis of relative displacement between the HX wearable robotic exoskeleton and the user's hand. J Neuroeng Rehabil. 2014 Oct 18;11:147. doi: 10.1186/1743-0003-11-147.
Results Reference
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Links:
URL
http://www.wayproject.eu
Description
Project Website

Learn more about this trial

Daily-life Brain Control Of A Hand Exoskeleton After Cervical Spinal Cord Injury

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