Effect of Anodal Transcranial Direct Current Stimulation on Postdural Puncture Headache: Results of Two Randomized Sham - Controlled Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
Post-dural puncture headache (PDPH) is the most prevalent complication in patients undergoing diagnostic or therapeutic lumbar puncture (LP). The pathophysiology of PDPH is primarily attributed to the mechanical traction on pain-sensitive intracranial nerves (e.g., the upper cervical, 5th, 9th, and 10th cranial nerves) and vascular structures, mediated by persistent dural damage leading to cerebrospinal fluid (CSF) leakage and subsequent CSF pressure reduction.
According to the International Classification of Headache Disorders 3rd edition (ICHD3), PDPH is classified as a headache subtype due to low CSF pressure. It typically manifests as an orthostatic headache within a few days post-LP, accompanied by symptoms such as neck pain, tinnitus, auditory changes, photophobia, and nausea. While PDPH usually resolves within 7-10 days, it can result in extended hospital stays and increased need for medication. The use of atraumatic needles is the most effective preventive measure for PDPH, though other commonly recommended practices such as bed rest, fluid administration, and caffeine have questionable efficacy.
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation (NIBS) technique that applies low-voltage electrical currents through surface electrodes on the scalp. Depending on the stimulation type-anodal or cathodal-tDCS can induce long-lasting increases or decreases in neuronal excitability and vascular-neuronal activity coupling. Research has shown that anodal tDCS (a-tDCS) applied to the primary motor cortex (M1) can alleviate various pain conditions, including fibromyalgia, neuropathic pain, and headaches. The pain-relieving effects of M1 a-tDCS are believed to follow the modulation of intracortical inhibitory GABAergic transmission, and the descending connections from M1 to the thalamus and periaqueductal gray.
Although short-term a-tDCS treatment has shown promise in preventing migraines and medication-overuse headaches, its role in preventing and treating PDPH remains unexplored. This study aims to evaluate the efficacy of preventive and therapeutic a-tDCS applied to M1 in patients undergoing diagnostic LP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •age between 18 and 75 years;
- •indication to undergo diagnostic lumbar puncture LP.
排除标准
- •any prior exposure to brain stimulation;
- •contraindications to tDCS;
- •a previous diagnosis of migraine or chronic headache;
- •usage of preventive medication at the baseline assessment;
- •history of depression
- •multiple lumbar puncture LP attempts.
- •cognitive impairment
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: From enrollment to the end of treatment at 1 week
The primary outcome was to assess differences between the two groups in PDPH-related pain, evaluated using the Visual Analogue Scale (VAS) and referred to pain intensity at that specific moment. The VAS is a self administered scale in which patients indicate the intensity of pain experienced by selecting a point on a continuous line ranging from 0 to 100 mm, representing the absence of pain to the worst pain, respectively. This scale is widely used in pain studies, with demonstrated validity and reproducibility. In the Th-tDCS study, VAS was administered at T0, before starting tDCS, and two hours before and two hours after the tDCS sessions (T1, T2, T3, T4, and T5). In the Pr-tDCS study, VAS was administered each day at the end of tDCS sessions (T0, T1, and T2).
次要结局
- Brief Pain Inventory (BPI)(From enrollment to the end of treatment at one week)
研究者
Diego Centonze
Head of Neurology Unit
Neuromed IRCCS