Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetic Peripheral Neuropathy
- Lower Extremity Amputee
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The project will take the form of a series of controlled single-subject feasibility and proof-of-concept studies with repeated measures. Subjects will act as their own concurrent controls with and without sensory stimulation, as well as their own longitudinal (historical) controls pre- and post-implementation of the Sensory Neuroprosthesis.Masking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The goal of this project is to enhance the mobility and daily function of Veterans who have lost a lower limb due to diabetic peripheral neuropathy by providing feedback of foot-floor interactions via a Sensory Neuroprosthesis employing neural stimulation. In parallel, the investigators aim to asses...
The goal of this project is to enhance the mobility and daily function of Veterans who have lost a lower limb due to diabetic peripheral neuropathy by providing feedback of foot-floor interactions via a Sensory Neuroprosthesis employing neural stimulation. In parallel, the investigators aim to assess the potential of this intervention to impact reports of phantom pain and improve the health and viability of the tissue of the residual limb in all recipients of the system regardless of the etiology of their limb loss. Electrodes are surgically implanted on one to four nerves of the residual limb. An external stimulation device will send pulses to the electrodes. The participant will be asked what they feel, and to draw the location of any perceived sensation on schematic maps. A sensorized prosthesis will be worn and stimulation will be administered while the participant is engaging in various functional tasks, such as standing, walking or climbing stairs or with visual or mental distractions. The investigators will apply standard subjective pain inventories and objective physiological measures of tissue health (e.g., temperature or oxygen perfusion) to document systemic changes related to context-appropriate electrically induced sensory input.
Tracking Information
- NCT #
- NCT04658693
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ronald Triolo, PhD Louis Stokes VA Medical Center, Cleveland, OH
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