RecruitingNot ApplicableNCT07377305

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)

Sponsor

Tang-Du Hospital

Enrollment

12 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

NMO Spectrum Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

Patients diagnosed with NMOSD in accordance with the criteria of the International Panel for Neuromyelitis Optica Diagnosis (IPND).
Patients were complicated with neuropathic pain, with a DN4 score ≥ 4.
NRS score for pain ≥ 4 points, and neuropathic pain has persisted for more than 3 months.
Patients receiving biological therapy and/or prednisone at a stable dose, with no adjustment of the treatment plan within 30 days before enrollment.
Patients who have not adjusted any combination of standard analgesic drugs (including antiepileptic drugs, antidepressants, and opioid drugs) within 30 days before enrollment.
Patients or their family members who have signed a written informed consent form.

Exclusion Criteria12

Subjects participating in other clinical studies.
Subjects who have used investigational drugs for pain control within 30 days before enrollment.
Subjects with a concurrent diagnosis of peripheral neuropathy.
Subjects with concurrent active central nervous system diseases.
Subjects with cognitive or mental disorders.
Subjects who are pregnant, lactating, or planning to become pregnant during the study period.
Subjects with severe diseases related to the heart, liver, kidneys, or hematopoietic system.
Subjects with implanted devices in the body (such as cardiac pacemakers, nerve stimulators, etc.).
Subjects with a history of transcutaneous electrical nerve stimulation (TENS) allergy, latex allergy, or previous intolerance.
Subjects with contraindications to MRI examination.
Subjects with head skin lesions.
Other medical conditions or situations that the researcher deems may affect the achievement of the study objectives.