Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

Not Applicable

Recruiting

• Conditions: Diabetic Neuropathies; Chronic Pain

• Registration Number: NCT03625752
• Lead Sponsor: Case Western Reserve University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-7-27
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Able to provide informed consent to participate in the study.<br><br> 2. Subjects between 40 to 80 years old.<br><br> 3. Having diabetic neuropathic pain, involving at least 1 foot, with existing pain for<br> at least 6 months, and having pain on at least half the days in the past 6 months<br> with an average of at least a 4 on a 0-10 VAS scale).<br><br> 4. Having pain resistant to common analgesics and medications for first-line therapy of<br> chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex,<br> Codeine, etc.<br><br> 5. Must have the ability to feel pain as self-reported.<br><br>Exclusion Criteria:<br><br> 1. Subject is pregnant.<br><br> 2. Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the<br> brain or implanted brain medical devices<br><br> 3. History of alcohol or drug abuse within the past 6 months as self-reported.<br><br> 4. Use of carbamazepine within the past 6 months as self-reported.<br><br> 5. Suffering from severe depression (with a PHQ 9 score of = 10).<br><br> 6. History of neurological disorders as self-reported.<br><br> 7. History of unexplained fainting spells as self-reported.<br><br> 8. History of severe head injury resulting in more than a momentary loss of<br> consciousness as self-reported.<br><br> 9. History of neurosurgery as self-reported.<br><br> 10. Unstable pain (defined as pain intensities that vary by more than 4 points on 0-10<br> VAS scale over the 1-week period of trial run-in).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in pain as measured by the Visual Analog Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Changes in the Verbal Rating Scale (VRS) for Pain;Changes in Conditional Pain Modulation;Changes in Visual Analog Scalefor Mood (VAMS);Montreal Cognitive Assessment;4-choice reaction time;N-back tests;Electroencephalography;Walking test;Functional reach test;Study 36-Item Short Form (SF-36);Patient Health Questionnaire (PHQ-9);American Pain Foundation Pain and Medication Diary;Multidimensional Pain Inventory (MPI);Brief Pain Inventory-DPN;Adverse events