ACTIVE_NOT_RECRUITING

Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

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Conditions

Diabetic NeuropathiesChronic Pain

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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 study is to assess the effects of Transcranial Direct Current Stimulation (tDCS) in combination with Transcranial ultrasound (TUS) for the treatment of pain and functional limitations in subjects with Diabetic Neuropathic Pain.

Official Title

Optimization of Non-Invasive Brain Stimulation for Diabetic Neuropathy

Quick Facts

Study Start:2019-06-06
Study Completion:2026-05-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03625752

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:40 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Able to provide informed consent to participate in the study.
  2. 2. Subjects between 40 to 80 years old.
  3. 3. Having diabetic neuropathic pain, involving at least 1 foot, with existing pain for at least 6 months, and having pain on at least half the days in the past 6 months with an average of at least a 4 on a 0-10 VAS scale).
  4. 4. Having pain resistant to common analgesics and medications for first-line therapy of chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, Codeine, etc.
  5. 5. Must have the ability to feel pain as self-reported.
  1. 1. Subject is pregnant.
  2. 2. Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices
  3. 3. History of alcohol or drug abuse within the past 6 months as self-reported.
  4. 4. Use of carbamazepine within the past 6 months as self-reported.
  5. 5. Suffering from severe depression (with a PHQ 9 score of ≥ 10).
  6. 6. History of neurological disorders as self-reported.
  7. 7. History of unexplained fainting spells as self-reported.
  8. 8. History of severe head injury resulting in more than a momentary loss of consciousness as self-reported.
  9. 9. History of neurosurgery as self-reported.
  10. 10. Unstable pain (defined as pain intensities that vary by more than 4 points on 0-10 VAS scale over the 1-week period of trial run-in).

Contacts and Locations

Principal Investigator

Salim Hayek, MD PhD
PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center/ Case Western Reserve University

Study Locations (Sites)

Ciro Ramos Estebanez
Chicago, Illinois, 60612
United States
University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit
Cleveland, Ohio, 44106-1716
United States

Collaborators and Investigators

Sponsor: Case Western Reserve University

  • Salim Hayek, MD PhD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center/ Case Western Reserve University

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 Date2019-06-06
Study Completion Date2026-05-07

Study Record Updates

Study Start Date2019-06-06
Study Completion Date2026-05-07

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetic Neuropathies
  • Chronic Pain