Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

Last updated: June 26, 2025
Sponsor: Case Western Reserve University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

Active Comparator: Active tDCS + Active TUS

Sham

Clinical Study ID

NCT03625752
STUDY20180314-2/20201584
  • Ages 40-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion 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 forat least 6 months, and having pain on at least half the days in the past 6 monthswith 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 ofchronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex,Codeine, etc.

  5. Must have the ability to feel pain as self-reported.

Exclusion

Exclusion Criteria:

  1. Subject is pregnant.

  2. Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in thebrain 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 ofconsciousness 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 0-10VAS scale over the 1-week period of trial run-in).

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Active Comparator: Active tDCS + Active TUS
Phase:
Study Start date:
June 06, 2019
Estimated Completion Date:
May 07, 2026

Study Description

Active stimulation will be compared with compared to SHAM stimulation in DNP patients.

20 DNP patients, 10 per group, receive stimulation or sham for 5 consecutive days, 20 min/day, followed by 2, 4, and 6 weeks post-therapy. 9 visits plus screening/baseline (total 10 visits).

Subsequently, 40 DNP patients will be enrolled, 20 per group, giving 5 consecutive days, 20 min/day, followed by 2 weeks of bi-weekly stimulation or sham for 20 min/day (total stimulations n=9) and follow-ups at 2, 4, 6, & 8 weeks post-stim): 13 visits plus screening/ baseline (total 14 visits).

Connect with a study center

  • Ciro Ramos Estebanez

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit

    Cleveland, Ohio 44106-1716
    United States

    Site Not Available

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