Phase
Condition
Chronic Pain
Pain
Treatment
Active Comparator: Active tDCS + Active TUS
Sham
Clinical Study ID
Ages 40-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 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).
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.
Must have the ability to feel pain as self-reported.
Exclusion
Exclusion Criteria:
Subject is pregnant.
Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in thebrain 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 ofconsciousness as self-reported.
History of neurosurgery as self-reported.
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
Study Description
Connect with a study center
Ciro Ramos Estebanez
Chicago, Illinois 60612
United StatesSite Not Available
University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit
Cleveland, Ohio 44106-1716
United StatesSite Not Available
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