Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-01 @ 1:09 PM
Study NCT ID:
NCT04658693
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2020-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: