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

Recruiting now · Not applicable

Conditions studied: NMO Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT07377305

Run by

Tang-Du Hospital

People needed

12

Starts

2025-12-08

Expected to finish

2026-09-30

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tangdu Hospital — Xi'an, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

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