A Phase 1 interventional study of BNCI controlled hand exoskeleton in Spinal Cord Injury, sponsored by University Hospital Tuebingen. Completed at 1 site in Spain. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-05-14.
Sponsored by University Hospital Tuebingen · Phase 1, Interventional, and Supportive care
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 6 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
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
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
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.
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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University Hospital Tuebingen