NCT04658693 Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 15 participants in total. It began in 2021-03-02 with a primary completion date of 2027-09-02.

Brief Summary

The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with above and below the knee limb loss. The investigators will implanted stimulating electrodes to send small electrical currents to the remaining nerves. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how the information about your foot and lower limb used to be transferred to the brain prior to your limb loss. Additionally, there is the option to have muscle recording electrodes implanted within the muscles of the lower limb with the goal to develop a motor controller that would allow the user to have intuitive control of a robotic prosthetic leg.

Eligibility Criteria

Inclusion Criteria: * Chronic, medically stable lower limb amputation due to diabetes or insensate foot due to Diabetic peripheral neuropathy * Being ambulatory and ability to stand or walk with prosthesis or orthosis * Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials (SEP) 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: * Active pressure ulcers or chronic skin ulcerations * Uncontrolled diabetes with HbA1c greater than or equal to 69 mmol/mol (8.5%) * Significant vascular disease * Significant history of poor wound healing * Significant history of uncontrolled infections * Active infection * Significant pain in the foot, residual or phantom limb * Pregnancy * Inability to speak English: The study design requires the subject to communicate and describe the elicited sensations in their lower limb * History of vestibular or movement disorders that would compromise balance or walking * Class II or III obesity (Body Mass Index \> 35) * Uncontrolled depression, psychoses or cognitive impairments. Subjects with unstable mental illness or severe cognitive impairments may be unable to comply with a long term study schedule * Expectation that MRI will be required at any point for the duration of study or while percutaneous leads are in place. At this time MRI is contraindicated, subjects who require regular MRI should not enroll * Arthritis in the area of implant- Inflammation or stiffness in the area of implant could limit placement of the electrodes

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