DExterous Hand Control Through Fascicular Targeting (DEFT) - (Human Subjects)
University of Texas Southwestern Medical Center
25 participants
Jun 1, 2015
INTERVENTIONAL
Conditions
Summary
Our goal is to temporarily implant the following groups for 540 +/- 30 days: 1. Forearm FAST electrodes 1. Five human partial hand amputees (amputated at the level of the hand) with 2 FAST electrodes in the ulnar nerve and 2-5 FAST electrodes in the median nerve. 2. Five human hand and forearm amputees (amputated at the level of the forearm) with 2 FAST electrodes in the ulnar nerve and 2-5 FAST electrodes in the median nerve . 2. Arm FAST electrodes 1. Five human partial hand amputees (amputated at the level of the hand) with 2 FAST electrodes in the ulnar nerve and 2-5 FAST electrodes in the median nerve. 2. Five human hand and forearm amputees (amputated at the level of the forearm) with 2 FAST electrodes in the ulnar nerve and 2-5 FAST electrodes in the median nerve. 3. Five human hand, forearm and arm amputees (amputated at the level of the arm) with 2 FAST electrodes in the ulnar nerve and 2-5 FAST electrodes in the median nerve.
Eligibility
Inclusion Criteria10
- Criteria for Inclusion of Subjects:
- Hand, forearm and arm amputees:
- Male or female, age 18 and older, of any race or ethnicity
- Able and willing to sign Consent
- Able and willing to participate in all study activities including implantation, testing and explantation of the study device.
- Able to communicate effectively in English without an interpreter
- Overall and phantom pain are well-controlled and not incapacitating
- Criteria for Exclusion of Subjects:
- If MR neurogram and EMG/NCS study show nerve or muscle dysfunction/injury at a higher level than anticipated based on the appearance of the physical amputation stump, the subject may be excluded from the study due to adverse neuromuscular anatomy which would preclude use of the proposed experimental electrode implants. The radiographs will be used to confirm suitability of the amputation stump configuration. If the bony anatomy of the amputation stump is found to be unsuitable, the patient may be excluded from the study.
- Subjects who have a history of cardiac arrhythmia will be excluded from the study.
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Interventions
Implant temporary Fast electrodes and record the nerve signals that control delicate finger motions and play back the nerve signals that give the hand feelings of touch and movement.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT02994160