Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

Launched by CASE WESTERN RESERVE UNIVERSITY · Aug 9, 2018

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for people suffering from diabetic neuropathic pain, which is a type of chronic pain caused by diabetes. The researchers want to see if combining two techniques, called Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS), can help reduce pain and improve daily functioning for those affected. The trial is currently looking for participants who are between 40 to 80 years old, have had diabetic neuropathic pain for at least 6 months, and find that common pain medications are not helping.

If you join this trial, you can expect to receive the experimental treatment and be monitored closely by healthcare professionals. To be eligible, you should be able to provide consent, have pain in at least one foot, and must experience that pain frequently. However, certain individuals, such as pregnant women or those with specific medical conditions (like a history of severe depression or certain neurological disorders), will not be able to participate. This trial offers hope for better pain management in diabetic neuropathy, and your involvement could contribute to important findings in this area.

Gender

ALL

Eligibility criteria

• 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).