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

NCT04658693 | Recruiting DMC FDA Device

• 3 other identifiers: A3566-R1583890RX003566-01A1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Amputee; Diabetic Peripheral Neuropathy

Keywords

Sensory Feedback; Limb Loss; Prosthesis User

Outcome Measures

Primary Outcomes (2)

• Stimulation thresholds

  Quantify the minimum stimulation required to evoke electrically induced sensations on the phantom limb.

  9 months post implant

• Functional Gait Assessment (FGA)

  The Functional Gait Assessment is a 10 task test that measures postural stability. Each task is scored from 0 -3 with 0 indicating severe impairment in the task and 3 indicating normal ambulation. The scores are combined to give a total score. The maximum score is 30. A higher score indicates a better outcome.

  6 months post implant

Secondary Outcomes (1)

• Neuropathic Pain Syndrome Inventory (NPSI)

  4 years post implant

Study Arms (1)

Multi contact electrode implant and implanted electromyography recording electrodes

EXPERIMENTAL

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.

Device: Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode

Interventions

Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode DEVICE

See arm description

Also known as: Sensory Neuroprosthesis

Multi contact electrode implant and implanted electromyography recording electrodes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic, medically stable lower limb amputation due to diabetes or insensate foot due to Diabetic peripheral neuropathy
• Being ambulatory and ability to stand or walk with prosthesis or orthosis
• Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials (SEP) and the like
• Good skin integrity and personal hygiene
• Absence of autoimmune deficiencies, seizure disorders or cardiac abnormalities contraindicating stimulation
• Sufficient social support and personal ability to tolerate study procedures and comply with follow-up schedule

You may not qualify if:

• Active pressure ulcers or chronic skin ulcerations
• Uncontrolled diabetes with HbA1c greater than or equal to 69 mmol/mol (8.5%)
• Significant vascular disease
• Significant history of poor wound healing
• Significant history of uncontrolled infections
• Active infection
• Significant pain in the foot, residual or phantom limb
• Pregnancy
• Inability to speak English: The study design requires the subject to communicate and describe the elicited sensations in their lower limb
• History of vestibular or movement disorders that would compromise balance or walking
• Class II or III obesity (Body Mass Index \> 35)
• Uncontrolled depression, psychoses or cognitive impairments. Subjects with unstable mental illness or severe cognitive impairments may be unable to comply with a long term study schedule
• Expectation that MRI will be required at any point for the duration of study or while percutaneous leads are in place. At this time MRI is contraindicated, subjects who require regular MRI should not enroll
• Arthritis in the area of implant- Inflammation or stiffness in the area of implant could limit placement of the electrodes

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

RECRUITING

Related Links

• VA Center of Excellence website listing this and other ongoing studies.

Study Officials

• Ronald Triolo, PhD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronald Triolo, PhD

CONTACT

(216) 791-3800; ronald.triolo@va.gov

Aarika Sheehan, DPT

CONTACT

(216) 791-3800; Aarika.Sheehan@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 8, 2020
• Study Start: March 2, 2021
• Primary Completion (Estimated): September 2, 2027
• Study Completion (Estimated): September 2, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)