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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
VA Office of Research and Development
Study ID
NCT04658693
Status
Recruiting
Apply to this trial

Conditions

  • Diabetic Peripheral Neuropathy
  • Lower Extremity Amputee

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode — DEVICE
    See arm description

Study Details

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.

Key Dates

Start date
Mar 2, 2021
Status verified
Jun 2026
Primary completion
Sep 2, 2027
Completion
May 30, 2031

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Multi contact electrode implant and implanted electromyography recording electrodes
    Fifteen subjects with lower limb amputation will receive implanted multicontact stimulating nerve cuff electrodes connected to temporary percutaneous leads. During experimental testing, a small amount of stimulation will be applied to the nerves through the contacts of the multichannel cuff electrode.

Primary Outcome Measure

Stimulation thresholds [ Time Frame: 9 months post implant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Louis Stokes VA Medical Center, Cleveland, OHClevelandOhio44106-1702
Aarika Sheehan, DPT
[email protected]
(216) 791-3800
Jessica R Jarvela, MS BS
[email protected]
(216) 791-3800
Ronald Triolo, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Louis Stokes VA Medical Center, Cleveland, OH· Cleveland, OH

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