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

Study Overview
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Brief Summary
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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.

Official Title
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Restoration of Daily-life Hand Function Using a Brain/Neural-Computer Interaction (BNCI) System in Paralysis After Cervical Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: BNCI controlled hand exoskeleton


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. |