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Myoelectric Prosthesis
MIRA for Amputation (MIRA Trial)
N/A
Recruiting
Led By Robert Gaunt, PhD
Research Sponsored by Boninger, Michael, MD
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 12 months
Awards & highlights
MIRA Trial Summary
This trial tests a robotic limb for amputees that is controlled by sensing muscle activity and is implanted under the skin. Training is used to learn how to control it. The device can stay implanted for up to one year.
Who is the study for?
This trial is for adults aged 22-70 with a single lower arm amputation, who can understand and follow study instructions. They must be at least one year post-amputation, able to control forearm muscles independently, and not pregnant or planning pregnancy within the next 25 months. Exclusions include severe visual impairment, certain medical conditions like heart arrhythmias or infections, ongoing substance abuse (excluding limited cannabis use), recent cancer treatments outside of specific skin cancers, uncontrolled diabetes, and those needing MRI or similar procedures.Check my eligibility
What is being tested?
The trial tests a new myoelectric prosthesis called MIRA that's implanted under the skin to improve control over robotic limbs by sensing muscle activity in the residual limb. Participants will undergo surgery to implant MIRA and receive training on using it to control their prosthetic limb. The device remains implanted for up to a year before removal.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, risk of infection from surgery, possible inflammation around the device area, muscle strain during training with the prosthesis and general risks associated with sedation used during surgical procedures.
MIRA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Explanted
Secondary outcome measures
Adverse Events
Device Control
Peak-to-Peak Voltage
+1 moreMIRA Trial Design
1Treatment groups
Experimental Treatment
Group I: MIRA DeviceExperimental Treatment1 Intervention
All participants enrolled in the study and who meet eligibility criteria will be implanted with the MIRA device in their residual limb. There is no control group.
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Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,341 Previous Clinical Trials
649,384 Total Patients Enrolled
Boninger, Michael, MDLead Sponsor
Ripple Therapeutics CorporationIndustry Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no history of blood vessel problems that could affect healing.I do not need routine MRI, ultrasound, or diathermy for my care.I have had an amputation at or above my wrist on one arm.I am not taking any blood-thinning medications.I am not pregnant, breastfeeding, or planning to become pregnant in the next 25 months.It has been over a year since my amputation.I can manage without a prosthesis or have help for 6 weeks after surgery.I do not have severe phantom limb pain.I do not have a bone infection.I haven't had active cancer or needed chemotherapy in the last year.I have no history of severe heart rhythm problems.I am not on long-term steroids or drugs that weaken my immune system.My diabetes is under control and I do not solely rely on insulin.I understand the study's goals and can follow simple instructions.I am between 22 and 70 years old.I can communicate in English to follow study instructions.I do not have any ongoing infections or unexplained fevers.I am not immunocompromised nor do I have conditions that cause it.I have not had a seizure in the last two years.I can voluntarily move the muscles in my forearm.
Research Study Groups:
This trial has the following groups:- Group 1: MIRA Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the minimum age requirement for this experiment greater than 25 years?
"This medical trial demands that participants be between 22 and 70 years old. For younger patients, there is 1 separate study. Likewise, those over 65 have access to 76 distinct clinical trials."
Answered by AI
Are there opportunities for me to engage in this trial?
"Prerequisites for enrolment in this research project necessitate amputation and being aged between 22 and 70. The investigators are looking to recruit approximately 5 individuals into the trial."
Answered by AI
Does this clinical experiment have any vacancies for participants?
"Affirmative. Clinicaltrials.gov data shows that this medical trial is presently searching for participants, having first been posted on August 1st 2023 and updated most recently on March 3rd 2023. The investigators are seeking to enrol 5 patients from a single site."
Answered by AI
How many participants have signed up for this clinical experiment?
"Affirmative. By consulting the information on clinicaltrials.gov, it is evident that this medical trial was first posted August 1st and recently modified on March 3rd 2023; thus, actively recruiting for 5 individuals at a single location."
Answered by AI
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