Noninvasive Brain Stimulation for Diabetic Neuropathy

This trial explores whether non-invasive brain stimulation can reduce pain from diabetic neuropathy, a condition causing nerve damage and pain, often in the feet. Participants will receive either real brain stimulation (Active tDCS + Active TUS, which stands for Transcranial Direct Current Stimulation and Transcranial Ultrasound) or a sham (placebo-like) treatment to compare effects. Individuals who have experienced diabetic nerve pain for at least six months and find common painkillers unhelpful might be suitable candidates for this trial. The study aims to discover a new method to ease pain that doesn't respond to usual treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial does not specify if you need to stop taking your current medications, but it does mention that your pain should be resistant to common pain relievers like Tylenol, Aspirin, and Ibuprofen. It also states that you should not have used carbamazepine in the past 6 months.

Research has shown that using transcranial direct current stimulation (tDCS) and transcranial ultrasound (TUS) together is generally safe. In past studies, a 20-minute session with a current of 2 milliamps proved both effective and safe for individuals with nerve pain. The treatment is manageable, with no serious side effects reported when following standard guidelines. Overall, tDCS and similar low-intensity treatments are considered safe, with no major negative effects noted in previous research.¹²³⁴⁵

Researchers are excited about the combination of transcranial direct current stimulation (tDCS) and transcranial ultrasound (TUS) for treating diabetic neuropathy because it offers a noninvasive approach that targets the brain's neural pathways. Unlike current standard treatments that often involve medications to manage symptoms, this method directly influences brain activity without drugs. This innovative approach could provide a new avenue for relief with potentially fewer side effects, making it a promising option for those who haven't found success with traditional therapies.

In this trial, participants will receive either an active or sham treatment. Research has shown that transcranial direct current stimulation (tDCS), administered to participants in the active treatment arm, can reduce pain in individuals with diabetic nerve pain. One study found that five daily sessions of tDCS on a specific brain area called M1 provided immediate pain relief lasting up to four weeks. Animal studies have also shown positive results, suggesting that tDCS can ease nerve pain. Researchers are exploring the combination of tDCS with transcranial ultrasound (TUS), also included in the active treatment arm, to determine if it enhances pain-relieving effects. These findings suggest that this noninvasive brain treatment could be a promising option for managing diabetic nerve pain.¹²³⁴⁵