Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02994160
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : September 11, 2018
Sponsor:
Collaborators:
Defense Advanced Research Projects Agency
Nerves Incorporated, Inc.
Arizona State University
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Jonathan Cheng, University of Texas Southwestern Medical Center

Brief Summary:

Our goal is to temporarily implant the following groups for 180 +/- 30 days:

  1. Five human partial hand amputees (amputated at the level of the hand) with 2 FAST-LIFE electrodes, one inserted into the motor fascicle of the ulnar nerve and the other into the sensory fascicle.
  2. Five human hand and forearm amputees (amputated at the level of the forearm) with 2 FAST-LIFE electrodes in the ulnar nerve (one in the motor fascicle, one in the sensory fascicle) and 2-5 FAST-LIFE electrodes in the median nerve (one in the motor fascicle, one to four in the remaining sensory fascicles).

Condition or disease Intervention/treatment Phase
Amputation; Traumatic, Hand Other: FastLIFE electrode Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: DExterous Hand Control Through Fascicular Targeting (DEFT) - (Human Subjects)
Study Start Date : June 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: FastLIFE electrodes
Implant temporary FastLIFE 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: FastLIFE electrode
Implant temporary FastLIFE 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 Measures :
  1. Motor Assessment [ Time Frame: weekly beginning 2 days after implantation up to day 180 +/- 30 days ]
    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

  2. Sensory Assessment [ Time Frame: weekly beginning 2 days after implantation up to day 180 +/- 30 days ]
    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.

  3. Sensory-Motor Integration [ Time Frame: weekly beginning 2 days after implantation up to day 180 +/- 30 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Criteria for Inclusion of Subjects:

Hand and forearm 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:

  1. Patient has an existing myoelectric hand prosthesis and demonstrates proficiency during daily use
  2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994160


Contacts
Layout table for location contacts
Contact: Debby Noble 214-648-8686 debby.noble@utsouthwestern.edu
Contact: Jennifer Barillas 214-645-8907 jennifer.barillas@utsouthwestern.edu

Locations
Layout table for location information
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Debby Noble    214-648-8686    debby.noble@utsouthwestern.edu   
Contact: Jennifer Barillas    214-645-8907    jennifer.barillas@utsouthwestern.edu   
Principal Investigator: Jonathan Cheng, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Defense Advanced Research Projects Agency
Nerves Incorporated, Inc.
Arizona State University
University of Minnesota - Clinical and Translational Science Institute
Investigators
Layout table for investigator information
Principal Investigator: Jonathan Cheng, MD UT Southwestern Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jonathan Cheng, Associate Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02994160     History of Changes
Other Study ID Numbers: 092014-061
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jonathan Cheng, University of Texas Southwestern Medical Center:
peripheral nerve
intraneural electrode
hand amputation
forearm amputation
Additional relevant MeSH terms:
Layout table for MeSH terms
Amputation, Traumatic
Wounds and Injuries