NCT05768802

Brief Summary

The purpose of this research study is to see how well a new type of myoelectric prosthesis works. A myoelectric prosthesis is a robotic limb for amputees that is controlled by sensing the activity of muscles in the body above the amputation level. This study involves a medical procedure to implant the Myoelectric Implantable Recording Array (MIRA) in the residual limb. The procedure will be performed under sedation by a physician. When muscles contract, they generate an electrical signal that can be sensed by MIRA and used to control the prosthetic limb. Myoelectric prosthetic limbs normally use electrodes that are placed on the surface of the skin to control different movements. However, MIRA is implanted under the skin, which could improve the ability to control the myoelectric prosthesis. After the MIRA is implanted, training will occur to learn how to control the prosthesis using the muscles in the residual limb. The device can stay implanted for up to one year. The device will be removed (explanted) by a physician.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
52mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Dec 2030

First Submitted

Initial submission to the registry

February 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
2.8 years until next milestone

Study Start

First participant enrolled

January 16, 2026

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.9 years

First QC Date

February 10, 2023

Last Update Submit

February 25, 2026

Conditions

AmputationAmputation; Traumatic, Hand

Keywords

hand amputationwrist amputationtransradial amputation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Explanted

    Safety of the MIRA device will be measured by tracking the number of individuals explanted prior to the end of the study.

    12 months

Secondary Outcomes (4)

  • Adverse Events

    12 months

  • Peak-to-Peak Voltage

    12 months

  • Signal-to-Noise Ratio

    12 months

  • Device Control

    12 months

Study Arms (1)

MIRA Device

EXPERIMENTAL

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.

Device: Myoelectric Implantable Recording Array (MIRA)

Interventions

Myoelectric Implantable Recording Array (MIRA)DEVICE

The Myoelectric Implantable Recording Array (MIRA) will use electromyography to detect the electrical activity of forearm muscles and transmit that information to an externally-powered prosthetic limb. The MIRA is implanted under the skin.

MIRA Device

Eligibility Criteria

Age22 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have a unilateral transradial amputation or wrist disarticulation.
  • Subjects must demonstrate independent voluntary control of muscles in the flexor and extensor compartments of the forearm
  • Subjects must be over 1-year post-amputation at time of implantation.
  • Subjects must be between the ages of 22 and 70 years old. Subjects outside this age range may be at an increased surgical risk and increased risk of fatigue during prosthetic training.
  • Subjects must be able to communicate with the investigators in English because of the need to follow the instructions of the study team.
  • Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators.
  • Subjects must pass a neuropsychological and psychosocial assessment.
  • Documentation of informed consent must be obtained from the subject.

You may not qualify if:

  • Subjects must be able to function without the use of a prosthesis, or have access to assistance, for a period of 6 weeks following implantation and explantation surgeries.
  • Subjects must not have visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses.
  • Subjects who have another serious disease(s) or disorder(s) that could affect their ability to participate in this study (verified during pre-op anesthesia evaluation to determine surgical risk status) will be excluded.
  • Subjects must not have phantom limb pain that is self-reported to be severe (options are no pain, mild pain, moderate pain, severe pain).
  • Subjects must not have any type of implantable generator such as a pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator (DBS) or DBS leads, vagus nerve stimulator, or defibrillator.
  • Female subjects of childbearing age must not be pregnant, lactating, or plan to become pregnant during the next 25 months.
  • Subjects must have no history of peripheral vascular disease that could impact wound healing.
  • Subjects who require routine MRI, therapeutic ultrasound, or diathermy as part of their ongoing care will be excluded.
  • Subjects must not have osteomyelitis.
  • Subjects must have no history of intractable clinically relevant cardiac arrhythmias.
  • Subjects must have no active infection(s) or unexplained fever(s) (verified during pre-op anesthesia evaluation to determine surgical risk status).
  • Subject must have no history of ongoing untreated alcoholism.
  • Subject must not be receiving chronic oral or intravenous steroids or immunosuppressive therapy.
  • Subjects must not be receiving medications that affect blood coagulation.
  • Subjects must not have had active cancer within the past year (other than adequately treated basal cell or squamous cell skin cancer) or require chemotherapy.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Study Officials

  • Robert Gaunt, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sydney Bader, MS

CONTACT

412-648-4196syb17@pitt.edu

Debbie Harrington, BS

CONTACT

412-383-1355debbie.harrington@pitt.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 10, 2023

First Posted

March 14, 2023

Study Start

January 16, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2030

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Data will be shared with Ripple on a regular basis. All data will be de-identified. There is no definitive plan to share data with other researchers at this point in time.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Information will be shared throughout duration of collaboration with Ripple LLC.
Access Criteria
Collaborators will receive data and study materials according to existing data sharing agreements.

Locations

US(1)