Feasibility of Sensory Feedback for Lower Limb Amputees

May 3, 2023 updated by: Ronald Triolo, Louis Stokes VA Medical Center

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.

Study Overview

Detailed Description

Electrodes are surgically implanted on one to four nerves of the residual limb. An external wearable device controls the delivery of electrical pulses to the implanted system. The participant will be asked to verbally describe the perceived sensations and highlight their locations on a drawing of a foot presented to them on an electronic screen. An instrumented prosthesis will be developed such that perceived sensations would correspond to prosthesis interactions with the floor. This instrumented prosthesis, also known as a sensory neuroprosthesis, 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.

Intramuscular recording electrodes can be implanted in the lower limb(s) and/or hip muscles in order to obtain electromyography (EMG) signals. The EMG recordings from the residual muscles will be used to develop an algorithm which can operate an advanced robotic prosthesis in which the movement of the joint(s) could be controlled.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Louis Stokes VA Medical Center
        • Principal Investigator:
          • Ronald Triolo, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults age 18 or greater
  • Chronic, medically stable ( > 3 months) unilateral trans-tibial or trans-femoral amputation
  • 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 (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:

  • Uncontrolled diabetes with HbA1c greater than or equal to 69 mmol/mol (8.5%).
  • 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
  • Arthritis in the area of implant
  • History of vestibular or movement disorders that would compromise balance or walking
  • Class II or III obesity (Body Mass Index > 35)
  • Poor surgical candidate
  • Uncontrolled depression, psychoses or cognitive impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stimulating nerve electrodes & intramuscular recording electrodes

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.

See Arm Description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stimulation Thresholds
Time Frame: 9 months post implant
Quantify the minimum stimulation required to evoke electrically induced sensations on the phantom limb.
9 months post implant
Functional Gait Assessment (FGA)
Time Frame: 1 year post implant
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ronald Triolo, PhD, Louis Stokes VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2015

Primary Completion (Anticipated)

September 1, 2027

Study Completion (Anticipated)

September 1, 2027

Study Registration Dates

First Submitted

December 15, 2017

First Submitted That Met QC Criteria

January 17, 2018

First Posted (Actual)

January 24, 2018

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained through this study may be provided to qualified researchers with academic interest in neuroprostheses and amputee research. The shared data will be coded, with no PHI included. Approval of the request by local IRB and review of the PI(s) are prerequisites to the sharing of data with the requesting party.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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