RECRUITING

Spinal Cord Stimulation and Small Fiber 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

This is a prospective randomized control trial. Participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group. A time course of measurements before and after spinal cord stimulation (SCS) treatment (where applicable) will assess pain, DPN severity, small fiber nerve activity, and metabolic health markers.

Official Title

A Novel Neuromodulation Approach to Target Small Fiber Neuropathy Early in Diabetes and Measure Functional Recovery

Quick Facts

Study Start:2024-04-17
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06287736

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. * Over 18 years old
  2. * Diagnosis of diabetic peripheral neuropathy refractory to treatment with gabapentin or pregabalin and at least 1 other class of analgesic
  3. * Diagnosis of medically refractory pain secondary to diabetic neuropathy
  4. * Presence of pain for 12 months
  5. * Lower limb pain intensity score ≥4 on a visual analog scale
  6. * DN4 ≥4
  7. * Pass pre-operative neuropsychological assessment (surgical group only)
  8. * Capable of providing informed consent
  1. * Severe medical comorbidities that, in the opinion of the surgeon, exclude the patient from surgical intervention
  2. * Spinal disease with severe spinal stenosis or spinal cord compression in the region of the proposed spinal cord stimulator lead placement
  3. * Coagulopathy that cannot be corrected
  4. * Unable to discontinue blood thinning medications
  5. * Hemoglobin A1c level greater than 10
  6. * Presence of systemic infection
  7. * Pregnancy

Contacts and Locations

Study Contact

Destiny West
CONTACT
614-366-7822
Destiny.West@osumc.edu
Uchechi Okafor
CONTACT
614.293.4876
Uchechi.Okafor@osumc.edu

Principal Investigator

Brian Dalm, MD
PRINCIPAL_INVESTIGATOR
The Ohio State University Wexner Medical Center

Study Locations (Sites)

The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University

  • Brian Dalm, MD, PRINCIPAL_INVESTIGATOR, The Ohio State University Wexner Medical Center

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 Date2024-04-17
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-04-17
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetic Peripheral Neuropathy