Recruiting
Not applicable
Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) for Neuropathic Pain in Neuromyelitis Optica Spectrum Disorder (NMOSD)
Condition(s) studied
NMO Spectrum Disorder
Investigational drug(s) / intervention(s)
10Hz tTIS (2-4mA) Intervention
10Hz tTIS (2-4mA) Intervention: tTIS (10Hz envelope field, current intensity 2-4mA)
Study 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
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.
Primary outcome measure(s)
- Change from baseline in numerical rating scale (NRS) score — Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment
Patients are followed up and NRS score is determined. In general, the minimum and maximum scores of NRS are 0 and 10, respectively, with higher scores meaning a worse outcome.
Trial sites (1)
| Facility | City | Region | Status |
| Tangdu Hospital |
Xi'an |
Shaanxi |
Recruiting |
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