Recruiting

DExterous Hand Control

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT02994160

Conditions

Amputation; Traumatic, Hand

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Fast electrode

Study Details

Brief 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.

Conditions

Amputation; Traumatic, Hand

Study ID

NCT02994160

Start date

Jun, 2015

Status verified date

Feb, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Fast electrodes

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.

Interventions

Fast 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.

Primary outcome measure

  • Motor Assessment [ Time Frame: up to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days ]
  • Sensory Assessment [ Time Frame: up to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days ]
  • Sensory-Motor Integration [ Time Frame: up to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days ]

Central Contacts and Locations

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Jonathan Cheng, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Mar 5, 2026

Last verified

Feb, 2026

Keywords

  • peripheral nerve
  • intraneural electrode
  • hand amputation
  • forearm amputation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-03-05.