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

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ClinicalTrials.gov Identifier: NCT02336321
Recruitment Status : Completed
First Posted : January 12, 2015
Last Update Posted : May 14, 2015
Sponsor:
Collaborators:
Institut Guttmann
Scuola Superiore Sant’Anna di Studi Universitari e di Perfezionamento
Information provided by (Responsible Party):
University Hospital Tuebingen

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: BNCI controlled hand exoskeleton Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Restoration of Daily-life Hand Function Using a Brain/Neural-Computer Interaction (BNCI) System in Paralysis After Cervical Spinal Cord Injury
Study Start Date : April 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BNCI hand-exoskeleton
Hand motor function before, during and after application of the device
Device: BNCI controlled hand exoskeleton
The BNCI system fuses and translates bio-signals related to user intention into control signals of an assistive device performing grasping motions




Primary Outcome Measures :
  1. Change of Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) 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. ]
    The TRI-HFT will be applied once before and while the patients wear the hand exoskeleton



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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers:   No
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

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): NCT02336321


Locations
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Spain
Instituto Guttmann, Hospital de Neurorehabilitació
Badalona, Catalonia, Spain, 08916
Sponsors and Collaborators
University Hospital Tuebingen
Institut Guttmann
Scuola Superiore Sant’Anna di Studi Universitari e di Perfezionamento

Additional Information:
Publications:
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02336321     History of Changes
Other Study ID Numbers: 288551-2
SO-932 ( Other Grant/Funding Number: German Research Foundation (DFG) )
WAY-288551 ( Other Grant/Funding Number: European Commission (EC) )
01GQ0831 ( Other Grant/Funding Number: Federal Ministry of Research and Education (BMBF) )
First Posted: January 12, 2015    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: March 2014

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System