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

University Hospital Tuebingen

Status and phase

Completed

Phase 1

Conditions

Spinal Cord Injury

Treatments

Device: BNCI controlled hand exoskeleton

Study type

Interventional

Funder types

Other

Identifiers

NCT02336321

01GQ0831 (Other Grant/Funding Number)

SO-932 (Other Grant/Funding Number)

288551-2

WAY-288551 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Ages

15 to 65 years old

Volunteers

No 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