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

NCT02994160 | Recruiting DMC

• 1 other identifier: STU 092014-061
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Our goal is to temporarily implant the following groups for 540 +/- 30 days:

1. 1.Forearm FAST electrodes
2. 2.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.
3. 3.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 .
4. 4.Arm FAST electrodes
5. 5.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.
6. 6.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.
7. 7.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

Keywords

peripheral nerve; intraneural electrode; hand amputation; forearm amputation

Outcome Measures

Primary Outcomes (3)

• Motor Assessment

  We will ask you to attempt to perform hand movements and positions. The movement trials will consist of simultaneous volitional movements and positioning of both the uninjured/sound limb and the injured/amputated "phantom" limb done. This allows us to have a physical record of exactly what movement is being attempted by the amputated limb. We will record nerve and muscle electrode activity during all of the movement trials. During some movement trials, we will stimulate the LIFE neural electrodes while recording from implanted vs. surface adhesive vs. percutaneous needle muscle electrodes

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

• Sensory Assessment

  We will also perform sensory detection and discrimination trials. Here, you will be asked to report if you detect any sensation during microstimulation (delivering very small electrical signals) via LIFE electrodes. If you do have a sensory perception, you will be asked to describe the quality and strength of the perception, e.g. location, touch, vibration, temperature. You may also be asked to fill out standardized sensory/pain assessments during microstimulation and after microstimulation is turned off. Other stimulation trials that may be done will include single or multiple electrode stimulation to see if subjects can perceive multiple sensory percepts simultaneously. Blinded trials may be done to determine if the subjects are actually perceiving the same percept for a given stimulation paradigm. Other trials may include modulating the stimulation parameters to determine if the sensory percept changes characteristics with varying stimulation paradigms.

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

• Sensory-Motor Integration

  After determining your sensory detection and discrimination parameters, we will ask you to repeat standardized assessments using the existing myoelectric partial hand prosthesis. Microstimulation via LIFE electrodes will be paired with motion or contact during task performance in order to determine whether providing evokes sensation during prosthesis use improves task-based performance.

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

Study Arms (1)

Fast electrodes

EXPERIMENTAL

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.

Other: Fast electrode

Interventions

Fast electrode OTHER

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.

Fast electrodes

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overall and phantom pain are well-controlled and not incapacitating
• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Defense Advanced Research Projects Agency: collaborator
• Nerves Incorporated, Inc.: collaborator
• Arizona State University: collaborator
• University of Minnesota: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Related Publications (3)

• Nguyen AT, Drealan MW, Khue Luu D, Jiang M, Xu J, Cheng J, Zhao Q, Keefer EW, Yang Z. A portable, self-contained neuroprosthetic hand with deep learning-based finger control. J Neural Eng. 2021 Oct 11;18(5). doi: 10.1088/1741-2552/ac2a8d.

  PMID: 34571503 DERIVED

• Nguyen AT, Xu J, Jiang M, Luu DK, Wu T, Tam WK, Zhao W, Drealan MW, Overstreet CK, Zhao Q, Cheng J, Keefer EW, Yang Z. A bioelectric neural interface towards intuitive prosthetic control for amputees. J Neural Eng. 2020 Nov 11;17(6). doi: 10.1088/1741-2552/abc3d3.

  PMID: 33091891 DERIVED

• Overstreet CK, Cheng J, Keefer EW. Fascicle specific targeting for selective peripheral nerve stimulation. J Neural Eng. 2019 Nov 11;16(6):066040. doi: 10.1088/1741-2552/ab4370.

  PMID: 31509815 DERIVED

Study Officials

• Jonathan Cheng, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debby Noble

CONTACT

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

Jennifer Barillas

CONTACT

214-645-8907; jennifer.barillas@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 15, 2016
• Study Start: June 1, 2015
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)