NCT04658693

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Electrodes are surgically implanted on one to four nerves of the residual limb. Intramuscular recording electrodes can be implanted in the lower limbs and hip muscles in order to obtain electromyography (EMG) signals. The EMG recordings will be used to develop an algorithm which can operate an advanced robotic prosthesis in which the prosthesis joint(s) movements could be controlled. An external wearable stimulation device controls the delivery of electrical pulses to the implanted system. An instrumented prosthesis will be developed such that perceived sensations would correspond to prosthesis interactions with the floor. The instrumented prosthesis will be worn while the participant is engaging in various functional tasks, such as standing, walking or climbing stairs or with visual or mental distractions.

Conditions

• Lower Extremity Amputee
• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode	See arm description

Timeline

• Start date: 2021-03-02
• Primary completion: 2027-09-02
• Completion: 2027-09-02
• First posted: 2020-12-08
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study