← Back to Search

Neuroprosthetic Implant

e-OPRA Implant System for Lower Limb Amputees

N/A
Waitlist Available
Led By Hugh M Herr, PhD
Research Sponsored by Integrum
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have adequate bone stock to support the implanted device
Patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above)
Must not have
Evidence of any active skin disease involving the proposed surgical limb
Active infection or dormant bacteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is to study the feasibility of a lower limb amputee with the e-OPRA Implant System exhibiting full neural control over a neuro-mechanical prosthetic system. A maximum of six subjects will be enrolled and will have the e-OPRA Implant System implanted. The subjects will participate in follow-up sessions of which the last one occurs approximately 24 months after the surgery.

Who is the study for?
This trial is for adults aged 22-65 who need a lower limb amputation and can walk at different speeds (K3 level). They must have enough healthy bone for the implant, not be pregnant or smoking, and have no severe health issues like diabetes or skin diseases. Participants should commit to follow-ups for two years after surgery.
What is being tested?
The e-OPRA Implant System is being tested on up to six people with leg amputations. It's an advanced prosthetic anchored directly into the bone that uses implanted electrodes for better control of the artificial limb. The study will check how well participants can use this new system over two years.
What are the potential side effects?
Potential side effects may include infection risks at the surgical site, possible irritation or reaction to the implant material, discomfort from electrodes, and challenges in adapting to neural control of the prosthetic.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My bones are strong enough to support an implant.
Select...
I can walk at different speeds.
Select...
I am between 22 and 65 years old.
Select...
I need an amputation above my knee with at least 13 cm of thigh bone left.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an active skin condition on the limb where surgery is planned.
Select...
I have an active infection or dormant bacteria.
Select...
I have less than 2 mm of bone around where my implant would be.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Electrode function
Secondary study objectives
Preferred walking speed

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: e-OPRA Implant SystemExperimental Treatment1 Intervention
Implantation of e-OPRA Implant System in lower limb.

Find a Location

Who is running the clinical trial?

Massachusetts Institute of TechnologyOTHER
101 Previous Clinical Trials
12,822,019 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,670 Previous Clinical Trials
11,878,260 Total Patients Enrolled
IntegrumLead Sponsor
6 Previous Clinical Trials
169 Total Patients Enrolled
Hugh M Herr, PhDPrincipal InvestigatorMassachusetts Insititute of Technology
2 Previous Clinical Trials
42 Total Patients Enrolled

Media Library

e-OPRA Implant System (Neuroprosthetic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT03720171 — N/A
Amputation Research Study Groups: e-OPRA Implant System
Amputation Clinical Trial 2023: e-OPRA Implant System Highlights & Side Effects. Trial Name: NCT03720171 — N/A
e-OPRA Implant System (Neuroprosthetic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03720171 — N/A
Amputation Patient Testimony for trial: Trial Name: NCT03720171 — N/A
~1 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top