What this study is
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 involves delivering small electrical currents directly to remaining nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how information about the foot and lower limb used to be transferred to your brain prior to the amputation.
Individuals also have the option to have recording electrodes implanted within muscles of the lower limb(s) in an attempt to develop a motor controller that would enable the user to have intuitive control of a robotic prosthetic leg.
What's being tested
- Stimulating nerve electrodes and intramuscular recording electrodes
Intervention · DEVICE
See Arm Description
Study details
- Sponsor
- Louis Stokes VA Medical Center
- Conditions
- Amputation
- Enrolling
- 15 people
- Starts
- 2015-11-05
- Est. completion
- 2027-09-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openLouis Stokes VA Medical Center
Cleveland, Ohio, United States
- Aarika Sheehan, PT, DPT · Contact216-791-3800 ext. 65832Aarika.Sheehan@va.gov
- Ronald Triolo, PhD · Principal investigator
Recruiting
Study team
Sponsor
Louis Stokes VA Medical Center
Study ID 15046-H27
Principal investigator
Ronald Triolo, PhD
Louis Stokes VA Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.