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)
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Tang-Du Hospital
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change from baseline in numerical rating scale (NRS) score
概览
简要总结
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.
详细描述
Neuromyelitis optica spectrum disorder (NMOSD) is a rare but severe demyelinating condition that affects mainly adult patients. In the course of NMOSD, pain is a common accompanying symptom, aside from other symptoms such as visual impairment, limb weakness, limb numbness, and urinary and fecal dysfunction. Among these, neuropathic pain is the most common, affecting over 80% of patients with NMOSD. It occurs not only during the acute phase of NMOSD but also serves as the main form of chronic pain. Currently, there is no standard clinical protocol for the treatment of neuropathic pain, and the efficacy of analgesic drugs is limited. Transcranial temporal interference stimulation (tTIS) is emerging as a non-invasive therapeutic alternative to deep brain stimulation (DBS). Studies have shown that tTIS exerts a positive impact on neural function, including enhancing memory function and improving motor function. While it still remains underdeveloped about tTIS in the field of pain management. Based on this, we intend to conduct a small-sample prospective self-controlled study. By analyzing the baseline clinical characteristics, we will compare the changes in pain scale scores (Numerical Rating Scale [NRS], Visual Analog Scale [VAS]), Global Impression Scales, Short-Form McGill Pain Questionnaire, Painful Spasm Frequency Scale, and Hamilton Anxiety/Depression Scale scores before and after tTIS treatment. Through this, we aim to evaluate the efficacy and safety of this therapeutic approach in subjects suffered from NMOSD-related neuropathic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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.
排除标准
- •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.
研究组 & 干预措施
Transcranial Current Stimulation (tTIS) Targeting Ventral Posterolateral Nucleus for Pain Treatment
tTIS (10Hz envelope field, current intensity 2-4mA) targeted at ventral posterolateral nucleus (contralateral to the pain side) for 5 consecutive days (20 minutes/ day)
干预措施: 10Hz tTIS (2-4mA) Intervention (Device)
结局指标
主要结局
Change from baseline in numerical rating scale (NRS) score
时间窗: 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.
次要结局
- Change from baseline in visual analog scale (VAS) score(Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment)
- Change from baseline in patient global impression of change (PGIC) score(Immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment)
- Change from baseline in short-form McGill pain questionnaire (SF-MPQ) score(Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment)
- Change from baseline in Penn spasm frequency scale (PSFS) score(Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment)
- Change from baseline in Hamilton anxiety rating scale (HAMA) score(Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment)
- Change from baseline in Hamilton depression rating scale (HAMD) score(Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment)
- Adverse events(Baseline up to 2 weeks after treatment)
研究者
Jun Guo, MD
Associate Professor
Tang-Du Hospital