RecruitingNot Applicable

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

United States25 participantsStarted 2015-06

Plain-language 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.

Who can participate

Age range

18 Years – 95 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Motor Assessment

Timeframe: up to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days

Sensory Assessment

Timeframe: up to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days

Sensory-Motor Integration

Timeframe: up to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days

Trial details

NCT IDNCT02994160

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03

Contact for this trial

Debby Noble

214-648-8686 debby.noble@utsouthwestern.edu

View on ClinicalTrials.gov More Amputation; Traumatic, Hand trials

Plain-language summary

Who can participate

Age range

18 Years – 95 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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.

What they're measuring

Motor Assessment

Timeframe: up to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days

Sensory Assessment

Timeframe: up to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days

Sensory-Motor Integration

Timeframe: up to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days