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 range18 Years – 95 Years

SexALL

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.
✕. Subjects who have a history of cardiac arrhythmia will 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

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 range18 Years – 95 Years

SexALL

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.
✕. Subjects who have a history of cardiac arrhythmia will 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