BridgeMD
New treatment option for Amputation
Official title Feasibility of Neural Feedback for Lower Limb Amputees
ClinicalTrials.gov ID: NCT03409133
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults age 18 or greater
- Chronic, medically stable ( \> 3 months) 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...
- Good skin integrity and personal hygiene
You likely 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
See the full eligibility criteria
- Adults age 18 or greater
- Chronic, medically stable ( \> 3 months) 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, 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.