RECRUITING

Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy

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 evaluate the effectiveness of providing sensation of the missing limb to individuals with above and below the knee limb loss. The investigators will implanted stimulating electrodes to send small electrical currents to the remaining nerves. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how the information about your foot and lower limb used to be transferred to the brain prior to your limb loss. Additionally, there is the option to have muscle recording electrodes implanted within the muscles of the lower limb with the goal to develop a motor controller that would allow the user to have intuitive control of a robotic prosthetic leg.

Official Title

Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy

Quick Facts

Study Start:2021-03-02
Study Completion:2027-09-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04658693

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. * Chronic, medically stable lower limb amputation due to diabetes or insensate foot due to Diabetic peripheral neuropathy
  2. * Being ambulatory and ability to stand or walk with prosthesis or orthosis
  3. * 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
  4. * Good skin integrity and personal hygiene
  5. * Absence of autoimmune deficiencies, seizure disorders or cardiac abnormalities contraindicating stimulation
  6. * Sufficient social support and personal ability to tolerate study procedures and comply with follow-up schedule
  1. * Active pressure ulcers or chronic skin ulcerations
  2. * Uncontrolled diabetes with HbA1c greater than or equal to 69 mmol/mol (8.5%)
  3. * Significant vascular disease
  4. * Significant history of poor wound healing
  5. * Significant history of uncontrolled infections
  6. * Active infection
  7. * Significant pain in the foot, residual or phantom limb
  8. * Pregnancy
  9. * Inability to speak English: The study design requires the subject to communicate and describe the elicited sensations in their lower limb
  10. * History of vestibular or movement disorders that would compromise balance or walking
  11. * Class II or III obesity (Body Mass Index \> 35)
  12. * Uncontrolled depression, psychoses or cognitive impairments. Subjects with unstable mental illness or severe cognitive impairments may be unable to comply with a long term study schedule
  13. * Expectation that MRI will be required at any point for the duration of study or while percutaneous leads are in place. At this time MRI is contraindicated, subjects who require regular MRI should not enroll
  14. * Arthritis in the area of implant- Inflammation or stiffness in the area of implant could limit placement of the electrodes

Contacts and Locations

Study Contact

Ronald Triolo, PhD
CONTACT
(216) 791-3800
ronald.triolo@va.gov
Aarika Sheehan, DPT
CONTACT
(216) 791-3800
Aarika.Sheehan@va.gov

Principal Investigator

Ronald Triolo, 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

  • Ronald Triolo, 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 Date2021-03-02
Study Completion Date2027-09-02

Study Record Updates

Study Start Date2021-03-02
Study Completion Date2027-09-02

Terms related to this study

Keywords Provided by Researchers

  • Sensory Feedback
  • Limb Loss
  • Prosthesis User

Additional Relevant MeSH Terms

  • Lower Extremity Amputee
  • Diabetic Peripheral Neuropathy