Noninvasive transcranial temporal interference stimulation for neuropathic pain in 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)

Researchers will try noninvasive transcranial temporal interference stimulation to reduce chronic neuropathic pain in adults with neuromyelitis optica spectrum disorder (NMOSD).

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tang-Du Hospital (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT07377305 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm, single-center prospective pilot at Tangdu Hospital delivers 10 Hz transcranial temporal interference stimulation (tTIS) at 2–4 mA to adults with NMOSD-related neuropathic pain. Patients serve as their own controls, with outcomes compared before and after the intervention using NRS, VAS, Global Impression Scales, the Short-Form McGill Pain Questionnaire, Painful Spasm Frequency Scale, and Hamilton Anxiety and Depression scales. Enrollment requires stable background immunotherapy and no recent changes to standard analgesics to limit confounding. The primary goals are to collect preliminary safety and efficacy data to inform the design of larger controlled trials.

Who should consider this trial

Good fit: Adults with clinician-diagnosed NMOSD who have persistent neuropathic pain (DN4 ≥ 4 and NRS ≥ 4 for more than 3 months) and stable immunotherapy/analgesic dosing are ideal candidates.

Not a fit: Patients with concurrent peripheral neuropathy, recent adjustments to pain or investigational therapies, or inability to attend the single center are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, tTIS could reduce chronic neuropathic pain and improve daily functioning without invasive surgery or major changes to existing drug regimens.

How similar studies have performed: Other noninvasive neuromodulation methods have shown mixed results for neuropathic pain, while tTIS itself is novel and largely untested for pain management.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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 this trial is running

Xi'an, Shaanxi

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

Study contacts

• Study coordinator: Jun GUO, Dr

Conditions NMO Spectrum Disorder