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.
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.
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.
Single group
10Hz tTIS (2-4mA) Intervention
DevicetTIS (10Hz envelope field, current intensity 2-4mA)
Change from baseline in numerical rating scale (NRS) score
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.
Change from baseline in visual analog scale (VAS) score
Patients are followed up and VAS score is determined. In general, the minimum and maximum scores of VAS are 0 and 10, respectively, with higher scores meaning a worse outcome.
Change from baseline in patient global impression of change (PGIC) score
Patients are followed up and PGIC score is determined. In general, the minimum and maximum scores of PGIC are 1 and 7, respectively, with higher scores meaning a worse outcome.
Change from baseline in short-form McGill pain questionnaire (SF-MPQ) score
Patients are followed up and SF-MPQ score is determined. In general, the minimum and maximum scores of SF-MPQ are 0 and 45, respectively, with higher scores meaning a worse outcome.
Change from baseline in Penn spasm frequency scale (PSFS) score
Patients are followed up and PSFS score is determined. In general, spasm frequency and spasm severity are evaluated. The minimum and maximum scores of spasm frequency are 0 and 4, respectively, with higher scores meaning a worse outcome. The minimum and maximum scores of spasm severity are 1 and 3, respectively, with higher scores meaning a worse outcome.
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