RECRUITING

Evaluation of Myoelectric Implantable Recording Array (MIRA) in Participants with Transradial Amputation

Conditions

Amputation Amputation; Traumatic, Hand hand amputation wrist amputation transradial amputation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of an Implantable Intramuscular Device to Control a Myoelectric Prosthesis

Quick Facts

Study Start:2025-01

Study Completion:2029-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05768802

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subjects must have a unilateral transradial amputation or wrist disarticulation. 2. Subjects must demonstrate independent voluntary control of muscles in the flexor and extensor compartments of the forearm 3. Subjects must be over 1-year post-amputation at time of implantation. 4. 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. 5. Subjects must be able to communicate with the investigators in English because of the need to follow the instructions of the study team. 6. Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators. 7. Subjects must pass a neuropsychological and psychosocial assessment. 8. Documentation of informed consent must be obtained from the subject.	1. 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. 2. Subjects must not have visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses. 3. 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. 4. Subjects must not have phantom limb pain that is self-reported to be severe (options are no pain, mild pain, moderate pain, severe pain). 5. 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. 6. Female subjects of childbearing age must not be pregnant, lactating, or plan to become pregnant during the next 25 months. 7. Subjects must have no history of peripheral vascular disease that could impact wound healing. 8. Subjects who require routine MRI, therapeutic ultrasound, or diathermy as part of their ongoing care will be excluded. 9. Subjects must not have osteomyelitis. 10. Subjects must have no history of intractable clinically relevant cardiac arrhythmias. 11. Subjects must have no active infection(s) or unexplained fever(s) (verified during pre-op anesthesia evaluation to determine surgical risk status). 12. Subject must have no history of ongoing untreated alcoholism. 13. Subject must not be receiving chronic oral or intravenous steroids or immunosuppressive therapy. 14. Subjects must not be receiving medications that affect blood coagulation. 15. 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. 16. Subjects must not have uncontrolled insulin dependent diabetes mellitus. 17. Subjects who have had a seizure in the last two years will be excluded. 18. Subjects who have attempted suicide in the past 12 months will be excluded. 19. Subjects who are immunosuppressed or who have conditions that typically result in immunocompromise (including, but not limited to: ataxia-telangiectasia, cancer, Chediak-Higashi syndrome, combined immunodeficiency disease, complement deficiencies, DiGeorge syndrome, HIV/AIDS, hypogammaglobulinemia, Job syndrome, leukocyte adhesion defects, malnutrition, panhypogammaglobulinemia, Bruton disease, congenital agammaglobulinemia, selective deficiency of IgA and Wiscott-Aldrich syndrome) will be excluded. 20. Subjects with active psychiatric concerns, including but not limited to major depression, bipolar disorder, schizophrenia or other psychotic disorder and post-traumatic stress disorder. Individuals undergoing effective treatment for any of these disorders will not be excluded, but will be evaluated by a rehabilitation psychologist. 21. Subjects who report use of controlled, non-prescribed substances other than cannabis/marijuana will be excluded. If a subject reports use of cannabis, we will use the DAST-10 questionnaire to screen for level of abuse. An individual may be included if the score is 5 or less and if the neuropsychologist deems that they are eligible. Subjects reporting use of cannabis will also undergo a urine drug test to screen for other nonprescribed drugs. Subjects will be excluded if they test positive for any non-prescribed substance other than cannabis.

Inclusion Criteria

Exclusion Criteria

1. Subjects must have a unilateral transradial amputation or wrist disarticulation.
2. Subjects must demonstrate independent voluntary control of muscles in the flexor and extensor compartments of the forearm
3. Subjects must be over 1-year post-amputation at time of implantation.
4. 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.
5. Subjects must be able to communicate with the investigators in English because of the need to follow the instructions of the study team.
6. Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators.
7. Subjects must pass a neuropsychological and psychosocial assessment.
8. Documentation of informed consent must be obtained from the subject.

1. 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.
2. Subjects must not have visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses.
3. 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.
4. Subjects must not have phantom limb pain that is self-reported to be severe (options are no pain, mild pain, moderate pain, severe pain).
5. 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.
6. Female subjects of childbearing age must not be pregnant, lactating, or plan to become pregnant during the next 25 months.
7. Subjects must have no history of peripheral vascular disease that could impact wound healing.
8. Subjects who require routine MRI, therapeutic ultrasound, or diathermy as part of their ongoing care will be excluded.
9. Subjects must not have osteomyelitis.
10. Subjects must have no history of intractable clinically relevant cardiac arrhythmias.
11. Subjects must have no active infection(s) or unexplained fever(s) (verified during pre-op anesthesia evaluation to determine surgical risk status).
12. Subject must have no history of ongoing untreated alcoholism.
13. Subject must not be receiving chronic oral or intravenous steroids or immunosuppressive therapy.
14. Subjects must not be receiving medications that affect blood coagulation.
15. 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.
16. Subjects must not have uncontrolled insulin dependent diabetes mellitus.
17. Subjects who have had a seizure in the last two years will be excluded.
18. Subjects who have attempted suicide in the past 12 months will be excluded.
19. Subjects who are immunosuppressed or who have conditions that typically result in immunocompromise (including, but not limited to: ataxia-telangiectasia, cancer, Chediak-Higashi syndrome, combined immunodeficiency disease, complement deficiencies, DiGeorge syndrome, HIV/AIDS, hypogammaglobulinemia, Job syndrome, leukocyte adhesion defects, malnutrition, panhypogammaglobulinemia, Bruton disease, congenital agammaglobulinemia, selective deficiency of IgA and Wiscott-Aldrich syndrome) will be excluded.
20. Subjects with active psychiatric concerns, including but not limited to major depression, bipolar disorder, schizophrenia or other psychotic disorder and post-traumatic stress disorder. Individuals undergoing effective treatment for any of these disorders will not be excluded, but will be evaluated by a rehabilitation psychologist.
21. Subjects who report use of controlled, non-prescribed substances other than cannabis/marijuana will be excluded. If a subject reports use of cannabis, we will use the DAST-10 questionnaire to screen for level of abuse. An individual may be included if the score is 5 or less and if the neuropsychologist deems that they are eligible. Subjects reporting use of cannabis will also undergo a urine drug test to screen for other nonprescribed drugs. Subjects will be excluded if they test positive for any non-prescribed substance other than cannabis.

Contacts and Locations

Study Contact

Sydney Bader, MS

CONTACT

412-648-4196

syb17@pitt.edu

Debbie Harrington, BS

CONTACT

412-383-1355

debbie.harrington@pitt.edu

Principal Investigator

Robert Gaunt, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

Robert Gaunt, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01

Study Completion Date2029-12

Study Record Updates

Study Start Date2025-01

Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

hand amputation
wrist amputation
transradial amputation

Additional Relevant MeSH Terms

Amputation
Amputation; Traumatic, Hand