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NCT02994160 · ClinicalTrials.gov registry record · NA

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

A NA study of Amputation; Traumatic, Hand, sponsored by University of Texas Southwestern Medical Center.

Recruiting
Registry status
NA
Development phase
25
Enrollment target
1
Study location

NCT02994160: Recruiting NA study of Amputation; Traumatic, Hand, sponsored by University of Texas Southwestern Medical Center.

NCT02994160 is a NA study of Amputation; Traumatic, Hand that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 25 participants, above the 17-participant average among 4 other Amputation; Traumatic, Hand trials with a reported enrollment target (47% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02994160, a NA study of Amputation; Traumatic, Hand, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.

RECRUITING
Registry status
NA
Development phase
25 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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 electrode

Interventions

  • OTHER Fast electrode

Study Locations (1)

Texas

  • UT Southwestern Medical Center - Dallas

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2015-06
Est. Completion 2028-03
Phase NA

What NCT02994160 shows while recruiting

NCT02994160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, above the 17-participant average among 4 other Amputation; Traumatic, Hand trials with a reported enrollment target (47% higher).

The record links to 1 condition, with Amputation; Traumatic, Hand appearing as the primary indexed condition, and to 1 intervention - of which Fast electrode is the first listed.

NCT02994160 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT02994160 about?

NCT02994160 is a clinical study titled "DExterous Hand Control Through Fascicular Targeting (DEFT) - (Human Subjects)". 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 forea...

What is the current status of trial NCT02994160?

This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2015-06. Estimated completion is 2028-03.

What conditions does trial NCT02994160 study?

This clinical trial studies the following conditions: Amputation; Traumatic, Hand.

What interventions are being tested in trial NCT02994160?

The interventions under investigation include: Fast electrode (OTHER).

Who is sponsoring clinical trial NCT02994160?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02994160 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT02994160, the US trial registry maintained by the National Library of Medicine. NCT02994160 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.