Proprioceptive Sensorimotor Integration With Neural Interfaces for Hand Prostheses

NCT04947462 | Recruiting DMC FDA Device

• 3 other identifiers: A3699-RRX003699-011624763-1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize proprioceptive sensations in the missing limb of upper limb amputees using nerve stimulation, and to develop advanced controllers for moving a prosthesis. Proprioceptive sensations are the sensations that tell individuals where their hand is in space, and if it is moving. The research team uses Functional Electrical Stimulation (FES), which involves applying small electric currents to the nerves. These signals are then transferred to the brain just like the information about the individual's intact hand used to be transferred to their brain. This study will test different placements for stimulation and determine which one(s) provide the individual with proprioceptive sensations. The investigators want to know what the participants feel and if the investigators can use proprioceptive sensation to give the participants information about limb movement and position.

Conditions

Upper Limb Amputees

Keywords

Proprioception; Prosthesis; Upper Extremity Limb Loss; Peripheral Nerve Stimulation; Embodiment; Sensorimotor; Neuroprostheses

Outcome Measures

Primary Outcomes (1)

• Magnitude of change in perceived joint position

  Magnitude of change in perceived joint position, as measured by joint angle transducers in the Cyberglove.

  This metric will be measured approximately each month for two years.

Study Arms (1)

Chronically Implanted Neural and Muscular Interface

EXPERIMENTAL

6 eligible participants will be chronically implanted with neural and muscular interfaces to characterize proprioceptive sensations using Functional Electrical Stimulation (FES).

Device: Chronically Implanted Neural and Muscular Interface

Interventions

Chronically Implanted Neural and Muscular Interface DEVICE

Participants will be chronically implanted with neural and muscular interfaces to characterize proprioceptive sensations using Functional Electrical Stimulation (FES).

Chronically Implanted Neural and Muscular Interface

Eligibility Criteria

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

You may qualify if:

• Unilateral upper limb amputation above or below the elbow with fully healed and healthy surgical sites
• Viable peripheral nerve function in the residual nerves serving the limb
• Volitional activity of the residual muscles in the amputated limb or actuating movement of the limb
• Medically fit to undergo general anesthesia
• Fitted with a prosthesis by a certified prosthetic and orthotic specialist (CPO) and at least one month of experience using a prosthesis
• Willingness and availability to follow the study protocol
• Willingness to undergo psychological evaluation, if recommended by study surgeons or investigators, to determine that the participant is mentally competent and capable of completing the study-related activities

You may not qualify if:

• Bilateral upper limb amputation, unless the amputation on the contralateral side only involves missing digits but does not qualify as a partial hand amputation
• Inability to speak English
• Medically unfit to undergo surgery
• Pregnancy, or those who are of childbearing potential, unwilling to prevent pregnancy during the trial
• Uncontrolled diabetes (HgbA1c\>8.0%)
• History of neuropathy and/or radiculopathy in the target limb
• Active infection or open sores on the residual limb
• History of frequent infection or sores with unknown cause
• Inability to provide informed consent or follow experimental protocols
• Severe pain that would prevent the participant from completing study-related activities
• Poor surgical candidate

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

• E. Gardner, J. Martin, in Principles of neural science (2000;

Study Officials

• Emily L Graczyk, PhD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily L Graczyk, PhD

CONTACT

(216) 791-3800; Emily.Graczyk@va.gov

Melissa S Schmitt

CONTACT

(216) 791-3800; Melissa.Schmitt@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

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 1, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)