Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
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- STATUS
- Recruiting
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- End date
- Jan 30, 2025
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- participants needed
- 10
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- sponsor
- VA Office of Research and Development
Summary
The study aims to apply implanted electrical stimulation to the residual nerves in Veterans who have lost lower limbs due to diabetic peripheral neuropathy. The goal would be to provide sensation to the missing limb to improve standing, walking and balance, and improve the health of the residual limb.
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 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.
Details
| Condition | Lower Extremity Amputee, Diabetic Peripheral Neuropathy |
|---|---|
| Treatment | Multi contact electrode implant |
| Clinical Study Identifier | NCT04658693 |
| Sponsor | VA Office of Research and Development |
| Last Modified on | 24 March 2022 |
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