Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

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.

Conditions

Diabetic Neuropathies, Chronic Pain

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Study Overview

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Study Details

Study overview

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.

Optimization of Non-Invasive Brain Stimulation for Diabetic Neuropathy

Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

Condition
Diabetic Neuropathies
Intervention / Treatment

-

Contacts and Locations

Chicago

Ciro Ramos Estebanez, Chicago, Illinois, United States, 60612

Cleveland

University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit, Cleveland, Ohio, United States, 44106-1716

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Able to provide informed consent to participate in the study.
  • 2. Subjects between 40 to 80 years old.
  • 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. 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. Must have the ability to feel pain as self-reported.
  • 1. Subject is pregnant.
  • 2. Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices
  • 3. History of alcohol or drug abuse within the past 6 months as self-reported.
  • 4. Use of carbamazepine within the past 6 months as self-reported.
  • 5. Suffering from severe depression (with a PHQ 9 score of ≥ 10).
  • 6. History of neurological disorders as self-reported.
  • 7. History of unexplained fainting spells as self-reported.
  • 8. History of severe head injury resulting in more than a momentary loss of consciousness as self-reported.
  • 9. History of neurosurgery as self-reported.
  • 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).

Ages Eligible for Study

40 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Case Western Reserve University,

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

Study Record Dates

2025-05-07