NCT07377305 Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) for Neuropathic Pain in Neuromyelitis Optica Spectrum Disorder (NMOSD)
| NCT ID | NCT07377305 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tang-Du Hospital |
| Condition | NMO Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-12-08 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2025-12-08 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07377305 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying NMO Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07377305 currently recruiting?
Yes, NCT07377305 is actively recruiting participants. Contact the research team at guojun_81@163.com for enrollment information.
Where is the NCT07377305 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT07377305 clinical trial?
NCT07377305 is sponsored by Tang-Du Hospital. The trial plans to enroll 12 participants.