RECRUITING

Peripheral Interfaces in Amputees for Sensorimotor Integration

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Conditions

Upper Extremity AmputeeSensory FeedbackAdvanced ControlSensorimotor feedbackProstheses and implants

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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 research is to gather information on the safety and effectiveness of an implanted wireless sensory enabled highly intuitive controlled prosthetic device.

Official Title

Peripheral Interfaces in Amputees for Sensorimotor Integration

Quick Facts

Study Start:2020-08-18
Study Completion:2032-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04430218

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:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 21 or greater
  2. * Acquired upper limb amputation
  3. * Unilateral or bilateral amputation, Above or below elbow
  4. * At least 6 months since time of amputation
  5. * Current user of a myoelectric prosthesis or prescribed to use one
  6. * Viable target nerves in the upper extremity \*
  7. * Recommendation from a psychologist following a psychological assessment that the subject is mentally competent and capable of completing the study related activities
  1. * A contraindication preventing surgery
  2. * Uncontrolled diabetes
  3. * Chronic skin ulcerations
  4. * History of poor wound healing without specific cause
  5. * History of uncontrolled infection without specific cause
  6. * Active infection
  7. * Pregnancy or women of childbearing potential unwilling to prevent pregnancy during participation in the study
  8. * Inability to speak English
  9. * Expectation that MRI will be required at any point for duration of study or while device is implanted.
  10. * Arthritis in the area of implant
  11. * Individuals with active implantable medical devices or individuals that use external active medical devices that are medically necessary and/or life-supporting or life-sustaining (e.g. insulin pumps, ventilators)
  12. * Presence of auto immune diseases, or conditions requiring immunosuppression.

Contacts and Locations

Study Contact

Dustin J Tyler, PhD
CONTACT
(216) 791-3800
dustin.tyler@va.gov
Melissa S Schmitt
CONTACT
(216) 791-3800
Melissa.Schmitt@va.gov

Principal Investigator

Dustin J. Tyler, 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

  • Dustin J. Tyler, 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 Date2020-08-18
Study Completion Date2032-06-30

Study Record Updates

Study Start Date2020-08-18
Study Completion Date2032-06-30

Terms related to this study

Keywords Provided by Researchers

  • Sensory Feedback
  • Advanced Control
  • Sensorimotor feedback
  • Prostheses and implants

Additional Relevant MeSH Terms

  • Upper Extremity Amputee