NCT07377305

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

A Single-center, Prospective, Single-arm Clinical Study: Evaluation of the Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) for Neuropathic Pain in Neuromyelitis Optica Spectrum Disorder (NMOSD)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, single-center prospective pilot study to assess the efficacy and safety of transcranial temperol interference stimulation in patients with neuromyelitis optica spectrum disorder (NMOSD) complicated by neuropathic pain in China.

Detailed description

Neuromyelitis optica spectrum disorder (NMOSD) is a rare but severe demyelinating condition that affects mainly adult patients. In the course of NMOSD, pain is a common accompanying symptom, aside from other symptoms such as visual impairment, limb weakness, limb numbness, and urinary and fecal dysfunction. Among these, neuropathic pain is the most common, affecting over 80% of patients with NMOSD. It occurs not only during the acute phase of NMOSD but also serves as the main form of chronic pain. Currently, there is no standard clinical protocol for the treatment of neuropathic pain, and the efficacy of analgesic drugs is limited. Transcranial temporal interference stimulation (tTIS) is emerging as a non-invasive therapeutic alternative to deep brain stimulation (DBS). Studies have shown that tTIS exerts a positive impact on neural function, including enhancing memory function and improving motor function. While it still remains underdeveloped about tTIS in the field of pain management. Based on this, we intend to conduct a small-sample prospective self-controlled study. By analyzing the baseline clinical characteristics, we will compare the changes in pain scale scores (Numerical Rating Scale \[NRS\], Visual Analog Scale \[VAS\]), Global Impression Scales, Short-Form McGill Pain Questionnaire, Painful Spasm Frequency Scale, and Hamilton Anxiety/Depression Scale scores before and after tTIS treatment. Through this, we aim to evaluate the efficacy and safety of this therapeutic approach in subjects suffered from NMOSD-related neuropathic pain.

Conditions

• NMO Spectrum Disorder

Interventions

Type	Name	Description
DEVICE	10Hz tTIS (2-4mA) Intervention	tTIS (10Hz envelope field, current intensity 2-4mA)

Timeline

• Start date: 2025-12-08
• Primary completion: 2026-06-01
• Completion: 2026-09-30
• First posted: 2026-01-29
• Last updated: 2026-01-29

Locations

1 site across 1 country: China