RECRUITING

Proprioceptive Sensorimotor Integration With Neural Interfaces for Hand Prostheses

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Proprioceptive Sensorimotor Integration With Neural Interfaces for Hand Prostheses

Quick Facts

Study Start:2021-12-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04947462

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Unilateral upper limb amputation above or below the elbow with fully healed and healthy surgical sites
  2. * Viable peripheral nerve function in the residual limb
  3. * Volitional activity of the residual muscles in the amputated limb
  4. * Medically fit to undergo general anesthesia
  5. * Fitted with a prosthesis by a certified prosthetic and orthotic specialist (CPO) and at least one month of experience using a prosthesis
  6. * Willingness and availability to follow the study protocol
  7. * Recommendation of a psychologist that the subject is mentally competent and capable of completing the study-related activities
  1. * Bilateral upper limb amputation
  2. * Inability to speak English
  3. * Medically unfit to undergo surgery
  4. * Pregnancy, or those who are of childbearing potential, unwilling to prevent pregnancy during the trial
  5. * Uncontrolled diabetes
  6. * Active infection or open sores on the residual limb
  7. * History of frequent infection or sores with unknown cause
  8. * Inability to provide informed consent or follow experimental protocols
  9. * Severe pain that would prevent the subject from completing study-related activities

Contacts and Locations

Study Contact

Emily L Graczyk, PhD
CONTACT
(216) 791-3800
Emily.Graczyk@va.gov
Melissa S Schmitt
CONTACT
(216) 791-3800
Melissa.Schmitt@va.gov

Principal Investigator

Emily L Graczyk, PhD
PRINCIPAL_INVESTIGATOR
Louis Stokes VA Medical Center, Cleveland, OH

Study Locations (Sites)

Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Emily L Graczyk, PhD, PRINCIPAL_INVESTIGATOR, Louis Stokes VA Medical Center, Cleveland, OH

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 Registration Dates

Study Start Date2021-12-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-12-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Upper Limb Amputees