Feasibility of Neural Feedback for Lower Limb Amputees

ConditionAmputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLouis Stokes VA Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Uncontrolled diabetes to a degree that would preclude surgery

Significant vascular disease

Chronic skin ulcerations

Significant history of poor wound healing

Trial design

Design model

Single group

Treatments tested in this trial

  • Stimulating nerve electrodes and intramuscular recording electrodes

    Device

    See Arm Description

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Stimulating nerve electrodes & intramuscular recording electrodesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Stimulation Thresholds

Quantify the minimum stimulation required to evoke electrically induced sensations on the phantom limb.

Time frame
9 months post implant
2

Functional Gait Assessment (FGA)

The Functional Gait Assessment is a 10 task test that measures postural stability. Each task is scored from 0 -3 with 0 indicating severe impairment in the task and 3 indicating normal ambulation. The scores are combined to give a total score. The maximum score is 30. A higher score indicates a better outcome.

Time frame
1 year post implant

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Louis Stokes VA Medical Center

Lead sponsor

Case Western Reserve University

Collaborator

United States Department of Defense

Collaborator