Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT03409133
Eligibility Criteria:
Inclusion Criteria:
* Adults age 18 or greater
* Chronic, medically stable ( \> 3 months) unilateral trans-tibial or trans-femoral amputation at the time of implant surgery.
* Potential user of trans-tibial or trans-femoral prostheses for standing or walking
* Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials and the like
* Good skin integrity and personal hygiene
* Absence of autoimmune deficiencies, seizure disorders or cardiac abnormalities contraindicating stimulation
* Sufficient social support and personal ability to tolerate study procedures and comply with follow-up schedule
Exclusion Criteria:
* Uncontrolled diabetes to a degree that would preclude surgery
* Significant vascular disease
* Chronic skin ulcerations
* Significant history of poor wound healing
* Significant history of uncontrolled infections
* Active infection
* Significant pain in the residual or phantom limb
* Pregnancy
* Inability to speak English
* Expectation that MRI will be required at any point for the duration of study or while percutaneous leads are in place
* Severe neurological conditions that significantly impair balance or mobility to an extent that independent ambulation is impossible without assistance ( as determined by a healthcare provider)
* Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
* Poor surgical candidate
* Psychiatric or cognitive conditions that could affect cooperation or understanding of instructions and willingness to undergo psychological evaluation, if recommended by study surgeons or investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03409133
Study Brief:
Protocol Section:
NCT03409133