Optimization of Non-Invasive Brain Stimulation for Diabetic Neuropathy

Status: Active_not_recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Illinois
Ciro Ramos Estebanez
Chicago
Ohio
University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit
Cleveland
Time Frame
Start Date: 2019-06-06
Completion Date: 2026-05-07
Participants
Target number of participants: 60
Treatments
Active_comparator: Active Comparator: Active tDCS + Active TUS
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
Sham_comparator: Sham
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Authors
Ciro Ramos Estebanez
Sponsors
Collaborators: Highland Instruments, Inc.
Leads: Case Western Reserve University

This content was sourced from clinicaltrials.gov