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New treatment option for Amputation
Official title Evaluation of Myoelectric Implantable Recording Array (MIRA) in Participants With Transradial Amputation
ClinicalTrials.gov ID: NCT05768802
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70
You may be able to join if
- people must have a unilateral transradial amputation or wrist disarticulation.
- people must demonstrate independent voluntary control of muscles in the flexor and extensor compartments of the forearm
- people must be over 1-year post-amputation at time of implantation.
- people must be between the ages of 22 and 70 years old. people outside this age range may be at an increased surgical risk and increased risk of...
- people must be able to communicate with the investigators in English because of the need to follow the instructions of the study team.
You likely can't join if
- people 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...
- people must not have visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses.
- people who have another serious disease(s) or disorder(s) that could affect their ability to participate in this study (verified during pre-op...
- people must not have phantom limb pain that is self-reported to be severe (options are no pain, mild pain, moderate pain, severe pain).
- people must not have any type of implantable generator such as a pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator (DBS) or...
- Female people of childbearing age must not be pregnant, lactating, or plan to become pregnant during the next 25 months.
See the full eligibility criteria
Who can join
- people must have a unilateral transradial amputation or wrist disarticulation.
- people must demonstrate independent voluntary control of muscles in the flexor and extensor compartments of the forearm
- people must be over 1-year post-amputation at time of implantation.
- people must be between the ages of 22 and 70 years old. people outside this age range may be at an increased surgical risk and increased risk of fatigue during prosthetic training.
- people must be able to communicate with the investigators in English because of the need to follow the instructions of the study team.
- people must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators.
- people must pass a neuropsychological and psychosocial assessment.
- Documentation of informed consent must be obtained from the subject.
What rules you out
- people 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.
- people must not have visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses.
- people 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.
- people must not have phantom limb pain that is self-reported to be severe (options are no pain, mild pain, moderate pain, severe pain).
- people 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 people of childbearing age must not be pregnant, lactating, or plan to become pregnant during the next 25 months.
- people must have no history of peripheral vascular disease that could impact wound healing.
- people who require routine MRI, therapeutic ultrasound, or diathermy as part of their ongoing care will be excluded.
- people must not have osteomyelitis.
- people must have no history of intractable clinically relevant cardiac arrhythmias.
- people 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.
- people must not be receiving medications that affect blood coagulation.
- people must not have had active cancer within the past year (other than adequately treated basal cell or squamous cell skin cancer) or require chemotherapy.
- people must not have uncontrolled insulin dependent diabetes mellitus.
- people who have had a seizure in the last two years will be excluded.
- people who have attempted suicide in the past 12 months will be excluded.
- people 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...
- people 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...
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.