Feasibility of Neural Feedback for Lower Limb Amputees

NCT03409133 | Recruiting FDA Device

• 1 other identifier: 15046-H27
• 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 lower limb loss, including above and below knee amputees. The approach involves delivering small electrical currents directly to remaining nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how information about the foot and lower limb used to be transferred to your brain prior to the amputation. Individuals also have the option to have recording electrodes implanted within muscles of the lower limb(s) in an attempt to develop a motor controller that would enable the user to have intuitive control of a robotic prosthetic leg.

Conditions

Amputation

Keywords

prosthesis user; phantom sensation; sensory feedback; prosthesis; amputee; amputation; limb loss; robotic prosthesis; neuroprosthesis; sensory restoration; robotic; electromyography; EMG; sensation; myoelectric

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.

  1 year post implant

Study Arms (1)

Stimulating nerve electrodes & intramuscular recording electrodes

EXPERIMENTAL

Fifteen subjects with lower limb amputation will have multi-contact stimulating nerve cuff electrodes implanted around the nerves in their residual limb. These electrodes will be connected to temporary percutaneous leads. During experimental testing, a small amount of electrical current will be delivered to the nerves through multi-contact nerve cuff electrodes. Participants also have the option to have recording electrodes implanted within muscles in their lower limb(s). These muscles are associated with prosthetic movement, and recordings from these muscles will be used to develop a controller for a robotic myoelectric prosthesis.

Device: Stimulating nerve electrodes and intramuscular recording electrodes

Interventions

Stimulating nerve electrodes and intramuscular recording electrodes DEVICE

See Arm Description

Stimulating nerve electrodes & intramuscular recording electrodes

Eligibility Criteria

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

You may qualify if:

• Adults age 18 or greater
• Chronic, medically stable ( \> 3 months) trans-tibial or trans-femoral amputation at the time of implant surgery.
• Potential user of trans-tibial or trans-femoral prostheses for standing or walking
• Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials 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:

• Uncontrolled diabetes to a degree that would preclude surgery
• Significant vascular disease
• Chronic skin ulcerations
• Significant history of poor wound healing
• Significant history of uncontrolled infections
• Active infection
• Significant pain in the residual or phantom limb
• Pregnancy
• Inability to speak English
• Expectation that MRI will be required at any point for the duration of study or while percutaneous leads are in place
• Severe neurological conditions that significantly impair balance or mobility to an extent that independent ambulation is impossible without assistance ( as determined by a healthcare provider)
• Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
• Poor surgical candidate
• Psychiatric or cognitive conditions that could affect cooperation or understanding of instructions and willingness to undergo psychological evaluation, if recommended by study surgeons or investigators.

Sponsors & Collaborators

• Louis Stokes VA Medical Center: lead
• Case Western Reserve University: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Louis Stokes VA Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Related Publications (1)

• Sheehan A, Siu R, Schmitt M, Vala J, Wright J, Kim D, Li S, Graczyk E, Triolo RJ, Charkhkar H. Impact of Long-Term Home and Community Use of a Lower Limb Sensory Neuroprosthesis. Res Sq [Preprint]. 2025 Sep 19:rs.3.rs-7412528. doi: 10.21203/rs.3.rs-7412528/v1.

  PMID: 41001531 DERIVED

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Ronald Triolo, PhD

  Louis Stokes VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aarika Sheehan, PT, DPT

CONTACT

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

jessica jarvela, MS

CONTACT

216-769-0531; jessica.jarvela@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: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Career Scientist, US Department of Veterans Affairs,

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: January 24, 2018
• Study Start: November 5, 2015
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Upon request, IPD sharing will begin 6 months after publication and will be available for up to 1 year. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of the request. Based on the extent of the request, written approvals from local IRB and execution of a Data Sharing Agreement (DSA) might be prerequisite. For more information or to submit a request, please contact Aarika.Sheehan@va.gov.

Locations

US (1)