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Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

Active, not recruitingNot applicableNCT03625752
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Optimization of Non-Invasive Brain Stimulation for Diabetic Neuropathy
Interventions
  • Device: Active Comparator: Active tDCS + Active TUS
  • Device: Sham
Sponsor
Case Western Reserve University
Collaborators
Highland Instruments, Inc.
Start date
2019-06-06
Primary completion
2027-05-01
Sex
All
Age range
from 40 Years to 80 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 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. Exclusion Criteria: 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).

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03625752