低强度经颅聚焦超声刺激治疗神经病理性疼痛：随机单盲安慰剂对照三臂平行组试验方案
Effect of Low-Intensity Transcranial Focused Ultrasound Stimulation on Neuropathic Pain: Protocol for a Randomized, Single-Blind, Placebo-Controlled, 3-Arm, Parallel-Group Trial
神经病理性疼痛（由神经损伤引起的慢性疼痛）常对药物反应不佳且副作用明显，无创脑刺激中高频rTMS对运动皮层有轻度镇痛作用，但难以刺激深部脑区。低强度经颅聚焦超声刺激（TUS）可精准作用于深部结构。该研究将纳入39名疼痛持续≥3个月、评分≥4的患者，随机分入运动皮层TUS、后上岛叶TUS或假刺激三组，每周一次共8周，主要看疼痛日记中每周平均疼痛强度变化。这是首个检验重复TUS长期疗效的随机对照试验，目前仍在招募中。
为什么推荐给您：首个检验重复经颅聚焦超声治疗神经病理性疼痛长期疗效的RCT，但为方案且样本小
不需要生物学背景，多打比方
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摘要Abstract
BACKGROUND: Neuropathic pain (NP) remains difficult to manage because conventional pharmacological therapies often have limited efficacy and intolerable side effects. Noninvasive neuromodulation techniques have emerged as potential alternatives with fewer adverse effects. Meta-analyses of randomized controlled trials suggest that high-frequency repetitive transcranial magnetic stimulation over the primary motor cortex has analgesic effects; however, its efficacy is modest and restricted by the inability to stimulate deeper brain regions. Low-intensity transcranial focused ultrasound stimulation (TUS) is a novel approach that enables precise targeting of deep brain structures and modulation of neural activity. Although promising in preclinical and preliminary human studies, its long-term therapeutic efficacy for NP remains unknown.
OBJECTIVE: This trial aims to explore the therapeutic effects and safety of repeated TUS sessions in patients with NP.
METHODS: This randomized, participant-blinded, placebo-controlled, 3-arm, parallel-group clinical trial will enroll 39 participants with NP (pain duration ≥3 months; pain intensity ≥4 on the numerical rating scale). Participants will be randomly allocated to one of three groups: (1) TUS targeting the primary motor cortex, (2) TUS targeting the posterior superior insula, or (3) sham stimulation. Each participant will undergo weekly sessions for 8 weeks. The primary outcome is change in weekly average pain intensity scores recorded in a pain diary. Secondary outcomes include additional pain scales, quality of life measures, psychological assessments, quantitative sensory testing, motor cortical excitability, and adverse events.
RESULTS: The first participant was enrolled on April 30, 2025, and 20 participants had been enrolled as of February 28, 2026, with enrollment ongoing. The final analysis will be conducted after completion of follow-up and data verification.
CONCLUSIONS: To our knowledge, this will be the first randomized controlled trial to examine the long-term therapeutic effects of repeated low-intensity TUS for NP. It will provide exploratory proof-of-concept data regarding its clinical efficacy and safety.