Recruiting

Proprioceptive IntegrationProprioceptive Sensorimotor Integration With Neural Interfaces for Hand Prostheses

Sponsor:

VA Office of Research and Development

Code:

NCT04947462

Conditions

Upper Limb Amputees

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chronically Implanted Neural and Muscular Interface

Study Details

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

Study ID

NCT04947462

Start date

Dec 1, 2021

Status verified date

Aug, 2026

Completion date

May 31, 2030

Anticipated

Primary completion date

May 31, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Veteran
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

Exclusion Criteria:

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 (Hemoglobin A1c (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

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Chronically Implanted Neural and Muscular Interface

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

Interventions

Chronically Implanted Neural and Muscular Interface

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

Primary outcome measure

Magnitude of change in perceived joint position [ Time Frame: This metric will be measured approximately each month for two years. ]

Central Contacts and Locations

Central contacts

Emily L Graczyk, PhD

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

Jessica R Jarvela, MS BS

(216) 791-3800 Jessica.Jarvela@va.gov

Locations

Louis Stokes VA Medical Center, Cleveland, OH

Recruiting

Cleveland, Ohio, United States, 44106-1702

Contacts

Jessica R Jarvela, MS BS

(216) 791-3800 Jessica.Jarvela@va.gov

Melissa S Schmitt

(216) 791-3800 Melissa.Schmitt@va.gov

Principal Investigator:

Emily L Graczyk, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-08-21.