DExterous Hand Control Through Fascicular Targeting (DEFT) - (Human Subjects)
University of Texas Southwestern Medical Center
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.
Description
Study Procedures: Subjects will be consented during a pre-operative visit in the Plastic Surgery Clinic and screened for participation. Screening history and physical Potential human subjects will receive a full medical assessment by the PI. The screening interview will focus on details of the patient's upper extremity condition and comprehensive details of the patient's overall health status. The screening examination will include general examination of the subject. Pre-operative imaging and diagnostic studies MRI, x-ray, EMG/Nerve conduction studies (NCS) - Each subject who passes the scr…
Eligibility
- Age range
- 18–95 years
- Sex
- All
- Healthy volunteers
- No
Criteria for Inclusion of Subjects: Hand, forearm and arm amputees: 1. Male or female, age 18 and older, of any race or ethnicity 2. Able and willing to sign Consent 3. Able and willing to participate in all study activities including implantation, testing and explantation of the study device. 4. Able to communicate effectively in English without an interpreter After preliminary screening subjects will be assessed for the following inclusion criteria: Overall and phantom pain are well-controlled and not incapacitating Criteria for Exclusion of Subjects: 1. If MR neurogram and EMG/NCS stu…
Interventions
- OtherFast electrode
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.
Location
- UT Southwestern Medical CenterDallas, Texas