Evaluation of Transcranial Temporal Interference Stimulation for Neuropathic Pain in Neuromyelitis Optica Spectrum Disorder A Single-center, Prospective, Single-arm Clinical Study

What this Trial Is About

Neuromyelitis optica spectrum disorder NMOSD is a rare but serious condition mainly affecting adults, often accompanied by neuropathic pain which can be chronic and difficult to treat. This study aims to evaluate the safety and effectiveness of transcranial temporal interference stimulation tTIS, a non-invasive brain stimulation technique, in patients with NMOSD who experience this type of pain. The study is an open-label, single-arm, single-center pilot trial conducted in China to explore this emerging therapy as an alternative to current limited pain treatments. Participants will receive tTIS targeting the ventral posterolateral nucleus on the side opposite to their pain. The stimulation uses a 10Hz envelope field with a current intensity ranging from 2 to 4mA, applied for 20 minutes daily over 5 consecutive days. This intervention is designed to assess potential improvements in pain and neurological function by comparing several clinical pain and mood scales before and after treatment. During the study, patients will undergo assessments including the Numerical Rating Scale NRS for pain, Visual Analog Scale VAS, Global Impression Scales, Short-Form McGill Pain Questionnaire, Painful Spasm Frequency Scale, and Hamilton Anxiety and Depression Scales. These measurements will be taken at baseline, immediately after treatment, and at 1- and 2-week follow-ups. Researchers will monitor adverse events throughout to evaluate the safety of tTIS. The total study duration extends from treatment through two weeks of follow-up to observe changes and potential benefits in neuropathic pain management.

Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) for Neuropathic Pain in Neuromyelitis Optica Spectrum Disorder (NMOSD)