Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Diabetic Neuropathies, Chronic Pain

In brief

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.

Key facts

Study ID

NCT03625752

Run by

Case Western Reserve University

People needed

60

Starts

2019-06-06

Expected to finish

2027-05-07

Last updated by the study team

2026-06-29

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to provide informed consent to participate in the study.
• Subjects between 40 to 80 years old.
• 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).
• 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.
• Must have the ability to feel pain as self-reported.

You may not qualify if…

• Subject is pregnant.
• Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices
• History of alcohol or drug abuse within the past 6 months as self-reported.
• Use of carbamazepine within the past 6 months as self-reported.
• Suffering from severe depression (with a PHQ 9 score of ≥ 10).
• History of neurological disorders as self-reported.
• History of unexplained fainting spells as self-reported.
• History of severe head injury resulting in more than a momentary loss of consciousness as self-reported.
• History of neurosurgery as self-reported.
• 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).

Where it is running

• Ciro Ramos Estebanez — Chicago, Illinois, United States
• University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.