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Neural Interface

Neural Interface for Upper Limb Amputation (PSI Trial)

N/A

Recruiting

Led By Emily L Graczyk, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Viable peripheral nerve function in the residual limb

Volitional activity of the residual muscles in the amputated limb

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this metric will be measured approximately each month for two years.

Awards & highlights

PSI Trial Summary

This trial is testing whether or not they can use electrical stimulation on the nerves of an amputee's missing limb in order to provide them with proprioceptive sensation (the sensation of where their hand is in space and if it is moving).

Who is the study for?

This trial is for individuals with a single upper limb amputation who are medically fit for anesthesia, have been using a prosthesis fitted by a specialist for at least one month, and can follow the study protocol. They must have good nerve function in the remaining limb and be mentally competent to participate. Pregnant women or those not preventing pregnancy, non-English speakers, people unfit for surgery, with uncontrolled diabetes or severe pain that interferes with activities are excluded.Check my eligibility

What is being tested?

The study aims to create sensations of hand position and movement (proprioception) in amputees by stimulating nerves through Functional Electrical Stimulation (FES). It will test different stimulation placements to evoke proprioceptive sensations and develop advanced prosthetic controllers based on these findings.See study design

What are the potential side effects?

Potential side effects may include discomfort from electrical stimulation, skin irritation where electrodes are placed, muscle fatigue due to repeated FES use, and possible psychological impacts from experiencing artificial sensations.

PSI Trial Eligibility Criteria

Inclusion Criteria

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

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My remaining limb has working nerves.

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I can control the muscles in my amputated limb.

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I am healthy enough to be put under general anesthesia.

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I have had one arm amputated above or below the elbow and the surgery site is fully healed.

PSI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this metric will be measured approximately each month for two years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this metric will be measured approximately each month for two years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this metric will be measured approximately each month for two years. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Magnitude of change in perceived joint position

PSI Trial Design

1Treatment groups

Experimental Treatment

Group I: Chronically Implanted Neural and Muscular InterfaceExperimental Treatment1 Intervention

6 eligible participants will be chronically implanted with neural and muscular interfaces to characterize proprioceptive sensations using Functional Electrical Stimulation (FES).

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,278 Total Patients Enrolled

2 Trials studying Upper Limb Amputation

25 Patients Enrolled for Upper Limb Amputation

Emily L Graczyk, PhDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH

Media Library

Chronically Implanted Neural and Muscular Interface (Neural Interface) Clinical Trial Eligibility Overview. Trial Name: NCT04947462 — N/A

Upper Limb Amputation Research Study Groups: Chronically Implanted Neural and Muscular Interface

Upper Limb Amputation Clinical Trial 2023: Chronically Implanted Neural and Muscular Interface Highlights & Side Effects. Trial Name: NCT04947462 — N/A

Chronically Implanted Neural and Muscular Interface (Neural Interface) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04947462 — N/A

Frequently Asked Questions

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

What is the current capacity to enroll participants in this clinical trial?

"Affirmative, according to the information presented on clinicaltrials.gov this medical trial is still actively recruiting patients. It was originally posted on December 1st 2021 and has been updated as recently as February 10th 2022. The researchers are looking for 6 individuals to enrol at one particular site."

Answered by AI

Is this research project presently enrolling participants?

"The clinical trial is in search of patients, as confirmed by the details on clinicaltrials.gov. This study first appeared online on December 1st 2021 and was most recently updated February 10th 2022."

Answered by AI