Innovative Neuromodulation Treatments for Chronic Pain: Assessing and Predicting the Effects of Personalized High-Definition Protocols for Transcranial Direct Current Stimulation (HD-tDCS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- Reduction of perceived pain
研究概览
简要总结
This study aims to examine the use of neurostimulation as a potential adjuvant treatment for chronic pain. Among neurostimulation techniques, transcranial direct current stimulation (tDCS) represents a promising, yet not fully exploited, option. Recent methodological advances allow for increased intensity and focality of its effects through personalized high-definition tDCS protocols (HD-tDCS), enabling targeted stimulation of specific brain regions involved in pain and analgesia processing, such as the dorsal anterior cingulate cortex (dACC).
Based on this evidence, the specific objective of the study is to investigate the effect of an innovative HD-tDCS protocol (personalized using structural and functional magnetic resonance imaging (fMRI)), with stimulation applied to the dACC. The experimental design involves randomly assigning 144 patients with chronic pain to three groups, who will undergo an intensive treatment (five sessions in the same week) with cathodal, anodal, or sham (placebo) HD-tDCS.
Patient recruitment and treatment will be equally distributed between sites located in Lombardy (IRCCS Maugeri-Pavia; University of Milano-Bicocca; n=72) and Palermo (IRCCS ISMETT-Palermo; University of Palermo; n=72).
The effects of neurostimulation will be: a) evaluated using self-reported measures of physical and social functioning (Brief Pain Inventory, BPI; primary outcome) before and after treatment, and at follow-up assessments at 3 weeks and 3 months; b) interpreted in relation to underlying neurophysiological changes, as revealed by the high spatial and temporal resolution provided, respectively, by fMR) and by transcranial magnetic stimulation-evoked potentials combined with electroencephalographic recording (TMS-EEG) before and after treatment (secondary outcome).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Diagnosis of chronic pain lasting for at least six months
- •Pain scores equal to or greater than 4 on Numerical Rating Scale (NRS) 0-10 on most days for the last 3 months
- •Pain unresponsive to conservative treatment such as pharmacological therapy and physiotherapy, and unresponsive to minimally invasive treatments such as peripheral nerve blocks or neuromodulation or steroid epidural injections, when appropriate
- •Age between 18 and 75
- •Stable pain levels and willingness not to modify any ongoing pain management therapies during the study period (1 week)
排除标准
- •History of seizure disorders
- •Active malignancy
- •Implanted medical devices and/or metallic implants in the head or neck region
- •Cranial abnormalities
- •Severe cognitive impairment (Montreal Cognitive Assessment (MoCA)<15.5)
- •Neurological or psychiatric conditions, or significant comorbidities, that may interfere with tDCS
- •Pregnancy
- •Incompatibility with MRI and/or TMS
研究组 & 干预措施
Anodal
Anodal HD-tDCS
干预措施: Anodal High-Definition transcranial Direct Current Stimulation (Device)
Cathodal
Cathodal HD-tDCS
干预措施: Cathodal High-Definition transcranial Direct Current Stimulation (Device)
Sham
Sham HD-tDCS
干预措施: Sham (No Treatment) (Device)
结局指标
主要结局
Reduction of perceived pain
时间窗: Baseline; Up to 3 weeks; After 3 months
We aim to assess the effect of a personalized (MRI-based) HD-tDCS protocol targeting dACC on clinical measures of perceived chronic pain. To this purpose, patients will be randomly assigned to 3 groups, each undergoing either cathodal, anodal or sham HD-tDCS treatment. Neurostimulation effects will be assessed with self-reported measures of perceived pain, collected via validated subjective functional questionnaires at 3 timepoints: before and after a 1-week (5 sessions) treatment, and at a 3 months follow-up assessment. The BPI score will be indeed considered the primary outcome measure for assessing the effect of HD-tDCS treatment, which will be deemed effective if a 30% reduction of pain intensity and interference on the BPI will be reached. The same statistical approach will be applied to the other clinical scales administered. In case of normality violations, data will be analyzed by means of non-parametric tests.
次要结局
- Change in pain-related neural sensitivity measured with fMRI and TMS-EEG(Baseline; Up to 3 weeks)