Status:
RECRUITING
Feasibility of Neural Feedback for Lower Limb Amputees
Lead Sponsor:
Louis Stokes VA Medical Center
Collaborating Sponsors:
Case Western Reserve University
United States Department of Defense
Conditions:
Amputation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with lower limb loss, including above and below knee amputees. The approach involve...
Detailed Description
Electrodes are surgically implanted on one to four nerves of the residual limb. An external wearable device controls the delivery of electrical pulses to the implanted system. The participant will be ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 5 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03409133
Start Date
November 5 2015
End Date
September 1 2027
Last Update
March 6 2025
Active Locations (1)
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1
Louis Stokes VA Medical Center
Cleveland, Ohio, United States, 44106