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

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

15 year–65 year

Study type

Interventional

Phase

Phase 1

Primary location

Instituto Guttmann, Hospital de Neurorehabilitació

Badalona, Catalonia, 08916, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BNCI controlled hand exoskeleton

Device

The BNCI system fuses and translates bio-signals related to user intention into control signals of an assistive device performing grasping motions

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

Institut Guttmann
Scuola Superiore Sant'Anna di Studi Universitari e di Perfezionamento

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2015
First posted: Jan 12, 2015
Registry last updated: May 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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