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

NCT ID: NCT04658693

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-02
• Study Completion Date: 2027-09-02

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.

Conditions

Lower Extremity Amputee; Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode

Intervention Type: DEVICE

See arm description

Interventions

Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode

See arm description

Intervention Type: DEVICE

Other Intervention Names

Sensory Neuroprosthesis

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Triolo, PhD

Role: PRINCIPAL_INVESTIGATOR

Louis Stokes VA Medical Center, Cleveland, OH

Locations

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ronald Triolo, PhD

Role: CONTACT

ronald.triolo@va.gov

(216) 791-3800

Aarika Sheehan, DPT

Role: CONTACT

Aarika.Sheehan@va.gov

(216) 791-3800 ext. 65832

Facility Contacts

Neal S Peachey, PhD

Role: primary

neal.peachey@va.gov

216-421-3221

Holly B Henry

Role: backup

holly.henry@va.gov

(216) 791-3800 ext. 64657

Related Links

https://www.aptcenter.research.va.gov/

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

Other Identifiers

1583890

Identifier Type: OTHER

Identifier Source: secondary_id

RX003566-01A1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

A3566-R

Identifier Type: -

Identifier Source: org_study_id