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

Exclusion Criteria21

• 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.
• Subjects must not have uncontrolled insulin dependent diabetes mellitus.
• Subjects who have had a seizure in the last two years will be excluded.
• Subjects who have attempted suicide in the past 12 months will be excluded.
• 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.
• 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.
• 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.