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DExterous Hand Control Through Fascicular Targeting (DEFT) - (Human Subjects)

Who can join

Ages 18 to 95 · All sexes

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 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.
2. Subjects who have a history of cardiac arrhythmia will be excluded from the study.

About the study

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.

What is being tested

• Fast electrode (other)

Sponsor: University of Texas Southwestern Medical Center · Participants: 25 · Started: 2015-06

Contact the study team

• Debby Noble · Phone: 214-648-8686
• Jennifer Barillas · Phone: 214-645-8907

Official record on ClinicalTrials.gov — NCT02994160

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.