RecruitingNot ApplicableNCT02994160

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


Sponsor

University of Texas Southwestern Medical Center

Enrollment

25 participants

Start Date

Jun 1, 2015

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 95 Years

Plain Language Summary

Simplified for easier understanding

This study implants experimental nerve electrode devices in the arms of amputees to test whether fine-grained electrical signals from the remaining nerves can be used to restore dexterous, individual finger-level control of a prosthetic hand. This is a novel approach to making prosthetics feel and behave more like real limbs. You may be eligible if: - You are 18 years of age or older - You have a hand, forearm, or arm amputation - You are willing and able to undergo implantation and removal of the experimental device - You can communicate effectively in English - Your phantom or residual limb pain is well controlled and not incapacitating You may NOT be eligible if: - MRI or nerve/muscle testing shows nerve damage at a higher level than expected from your amputation - Your amputation stump anatomy is unsuitable for the electrode implants - You have a history of cardiac arrhythmia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERFast 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.


Locations(1)

UT Southwestern Medical Center

Dallas, Texas, United States

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NCT02994160


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