Noninvasive transcranial temporal interference stimulation for neuropathic pain in NMOSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tangdu Hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Jun GUO, Dr
• Email: guojun_81@163.com
• Phone: (86)13991269132

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.