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Procedure

Fast Electrode for Hand Amputation

N/A

Recruiting

Led By Jonathan Cheng, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hand, forearm, and arm amputees of any race or ethnicity, aged 18 and older

Able and willing to participate in all study activities including implantation, testing, and explantation of the study device

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial is to test a new kind of electrode that can be implanted in order to help people who have had amputations. The electrode is placed in the nerve and the goal is to have it work for around six months.

Who is the study for?

This trial is for adults who have had a hand, forearm, or arm amputation and can manage their pain well. Participants must be able to sign consent, take part in all study activities including device implantation and removal, and communicate effectively in English without an interpreter.Check my eligibility

What is being tested?

The DEFT trial is testing 'FAST electrodes' implanted for about 540 days in the nerves of people with different levels of limb amputation. The goal is to improve control over prosthetic hands through advanced nerve targeting.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort at the electrode implantation site, possible nerve irritation or damage, and risks associated with surgical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult with an amputation of my hand, forearm, or arm.

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I am willing to follow all study procedures, including having a device implanted and removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Motor Assessment

Sensory Assessment

Sensory-Motor Integration

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fast electrodesExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Defense Advanced Research Projects AgencyFED

18 Previous Clinical Trials

78,898 Total Patients Enrolled

Arizona State UniversityOTHER

283 Previous Clinical Trials

109,489 Total Patients Enrolled

University of MinnesotaOTHER

1,381 Previous Clinical Trials

1,588,750 Total Patients Enrolled

Media Library

DEFT (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02994160 — N/A

Hand Amputation Research Study Groups: Fast electrodes

Hand Amputation Clinical Trial 2023: DEFT Highlights & Side Effects. Trial Name: NCT02994160 — N/A

DEFT (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02994160 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass participants aged 18 and over?

"This trial is open to individuals over 18 and under 95 years of age."

Answered by AI

How many participants are actively engaged in this medical experiment?

"That is correct. According to the clinicaltrials.gov page, this research program went live on June 1st 2015 and has been actively recruiting since then. Currently, 10 participants are needed at a single site location."

Answered by AI

Is enrollment still open for participation in this experiment?

"As listed on clinicaltrials.gov, this medical study is still recruiting candidates, with the trial first posted in June of 2015 and last updated in January 2022."

Answered by AI