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Neural Interface

e-OPRA Implant System for Transtibial Amputees for Amputation (TTeOPRA Trial)

N/A
Waitlist Available
Research Sponsored by Massachusetts Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

TTeOPRA Trial Summary

This trial is looking at a new implant system that allows for communication between the body and a prosthetic limb using implanted electrodes. The study is to evaluate the feasibility of the system and will implant the system in two subjects.

TTeOPRA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Electrode Robustness and Connector/Lead Integrity (amplitude)
Electrode Robustness and Connector/Lead Integrity (resistance)
Sensor Function and Signal Quality
Secondary outcome measures
Preferred Walking Speed

TTeOPRA Trial Design

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

Find a Location

Who is running the clinical trial?

Massachusetts Institute of TechnologyLead Sponsor
97 Previous Clinical Trials
12,729,985 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,608 Previous Clinical Trials
11,469,875 Total Patients Enrolled
IntegrumIndustry Sponsor
5 Previous Clinical Trials
166 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals have been inducted into this experiment thus far?

"Affirmative. The information on clinicaltrials.gov reveals that this experiment is actively recruiting, which commenced on November 3rd 2021 and was most recently modified in February 18th 2022. Two volunteers are needed to be enrolled from two separate testing centres."

Answered by AI

Is eligibility for this survey restricted to participants aged 20 or younger?

"This medical trial is available to participants aged 22 and up, but not over 65 years old."

Answered by AI

Is recruitment still taking place for this research endeavor?

"Indeed, the information located on clinicaltrials.gov suggests that this investigation is currently looking for volunteers. This study was initially posted back in November 3rd 2021 and has been recently updated February 18th 2022; it requires 2 participants to be enrolled from two different sites."

Answered by AI

Are there any opportunities to partake in this experiment?

"To qualify for this medical trial, potential participants must have lost a limb and range in age from 22 to 65 years old. It is estimated that approximately 2 individuals will be accepted into the study."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
Massachusetts
Michigan
How old are they?
18 - 65
What site did they apply to?
Brigham and Women's Hospital
MIT Media Lab
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. MIT Media Lab: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Osseointegrated Transtibial Prosthesis With Neural Interface
2021. "Osseointegrated Transtibial Prosthesis With Neural Interface". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05249049.
~1 spots leftby Apr 2025
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