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

Phase 1

Completed

• Conditions: Spinal Cord Injury
• Interventions: Device: BNCI controlled hand exoskeleton

• Registration Number: NCT02336321
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-03
• Study Start: 2014-04
• Primary Completion: 2014-10
• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2015-01-07
• Study First Posted: 2015-01-12
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-13
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BNCI hand-exoskeleton	BNCI controlled hand exoskeleton	Hand motor function before, during and after application of the device

Primary Outcome Measures

Name	Time	Method
Change of Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) Score	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

Trial Locations

Locations (1)

Instituto Guttmann, Hospital de Neurorehabilitació; 🇪🇸 Badalona, Catalonia, Spain