Using brain stimulation techniques to treat diabetic neuropathic pain

Optimization of Non-Invasive Brain Stimulation for Diabetic Neuropathy

This study is testing if a new combination of brain stimulation techniques can help people with diabetic neuropathic pain feel less pain and improve their daily function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Case Western Reserve University (Academic / other)
• Locations: 2 sites (Chicago, Illinois and 1 other locations)
• Trial ID: NCT03625752 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Transcranial Direct Current Stimulation (tDCS) combined with Transcranial Ultrasound (TUS) in alleviating pain and improving function in patients suffering from diabetic neuropathic pain (DNP). Participants will be divided into two groups, receiving either active stimulation or sham treatment over a series of sessions. The study will involve 20 initial patients followed by an additional 40, with assessments conducted at multiple time points post-treatment to gauge the effects. The goal is to determine if this combined approach can provide significant relief for those with chronic pain resistant to standard therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 80 with diabetic neuropathic pain lasting at least six months and resistant to common pain medications.

Not a fit: Patients with severe depression, neurological disorders, or contraindications to tDCS and TUS may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, non-invasive option for patients suffering from chronic diabetic neuropathic pain.

How similar studies have performed: While the combination of tDCS and TUS is a novel approach, previous studies have shown promise in using tDCS for pain management.

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).

Where this trial is running

Chicago, Illinois and 1 other locations

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

Study contacts

• Principal investigator: Salim Hayek, MD PhD — University Hospitals Cleveland Medical Center/ Case Western Reserve University
• Study coordinator: Megan O'Neill Miller

Conditions Diabetic Neuropathies; Chronic Pain