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Prosthetic Device

Thought-Controlled Bionic Arm for Arm Amputees (iSens Trial)

N/A

Recruiting

Led By Dustin J. Tyler, 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

Age 21 or greater

Acquired upper limb amputation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months post implant

Awards & highlights

iSens Trial Summary

This trial is testing a new kind of bionic arm that is controlled by the wearer's thoughts.

Who is the study for?

This trial is for adults over 21 who have had an upper limb amputation at least 6 months ago and are using or prescribed a myoelectric prosthesis. They must be mentally fit to participate, as confirmed by a psychologist, and have healthy nerves in the affected limb. People with poor wound healing, infections, pregnancy, inability to speak English, arthritis near the implant area or those needing MRI scans can't join.Check my eligibility

What is being tested?

The study tests 'iSens', an implanted wireless device that aims to enhance control of prosthetic limbs through improved sensory feedback. It's designed for people with arm amputations to see if it's safe and effective compared to current prosthetic devices.See study design

What are the potential side effects?

Potential side effects aren't specified but may include typical risks associated with surgical implants such as infection risk at the surgery site, possible inflammation around the implant area, discomfort or pain related to device use.

iSens Trial Eligibility Criteria

Inclusion Criteria

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

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I am 21 years old or older.

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I have had an amputation above my wrist.

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I have had one or both arms amputated, either above or below the elbow.

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My nerves in the upper arm are functioning.

iSens Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months post implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months post implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months post implant for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Patient Experience Measure

Secondary outcome measures

Modified Box and Blocks

iSens Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: iSensExperimental Treatment1 Intervention

3 months trial with the iSens system

Group II: State of the Art ProsthesisActive Control1 Intervention

3 months trial with their own prosthesis.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Defense Advanced Research Projects AgencyFED

18 Previous Clinical Trials

78,908 Total Patients Enrolled

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,269 Total Patients Enrolled

Dustin J. Tyler, PhDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH

Media Library

iSens (Prosthetic Device) Clinical Trial Eligibility Overview. Trial Name: NCT04430218 — N/A

Arm Amputee Research Study Groups: State of the Art Prosthesis, iSens

Arm Amputee Clinical Trial 2023: iSens Highlights & Side Effects. Trial Name: NCT04430218 — N/A

iSens (Prosthetic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04430218 — N/A

Frequently Asked Questions

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

How many participants are currently participating in this clinical trial?

"Affirmative. The clinicaltrials.gov website displays that the primary recruitment period for this medical trial began on August 18th 2020 and was most recently updated on February 3rd 2022. 15 participants are needed at a single site of enrollment."

Answered by AI

Are people from the general population being accepted into this experiment yet?

"As per the information available on clinicaltrials.gov, this medical research is actively enrolling participants. The trial was first published on August 18th 2020 and last updated February 3rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Peripheral Interfaces in Amputees for Sensorimotor Integration

2020. "Peripheral Interfaces in Amputees for Sensorimotor Integration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04430218.