Neuromodulation in Patients With Neuropathic Pain and Depression: a Cross-over Study Between Two Targets in Transcranial Magnetic Stimulation, the Primary Motor Cortex and the Dorsolateral Prefrontal Cortex.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparison of pain relief rates between the two stimulation targets (M1 and DLPFC)
研究概览
简要总结
High-frequency repetitive transcranial magnetic stimulation of the primary motor cortex has shown its effect on refractory neuropathic pain, and rTMS of the dorsolateral prefrontal cortex is commonly used for treatment-resistant depression.
The treatment for patients suffering from neuropathic pain and depression, concomitantly, still needs to be studied, as there are some specificities in both symptoms and brain functional MRI.
详细描述
This project is a cross-over study for these patients, including 4 sessions of either M1 or DLPFC rTMS, a wash-out period, followed by 4 sessions of the other stimulation site, to assess the efficiency of a DLPFC rTMS for neuropathic pain with a comorbid depression. Besides pain intensity and quality, patient's mood, quality of life, and catastrophizing will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Central or peripheral neuropathic pain
- •Chronic pain (present for more than 6 months) with intensity greater than or equal to 4/10 on the numerical scale
- •Pain present on a daily or near-daily basis (at least 4 days a week)
- •Patient not completely relieved by recommended drug treatments for first- and second-line neuropathic pain
- •Stable analgesic treatment (no new treatment or dosage adjustment) for at least one month, and will not need to be modified for the duration of the study.
- •Patient with a depressive episode characterized according to DSM V criteria
- •Indication for motor cortex rTMS by a neurologist
- •Patient can be followed for the entire duration of the study
- •Patient having received informed consent to participate in the study, and having co-signed a consent form with the investigator
- •Member or beneficiary of a social security scheme
排除标准
- •Industrial accident or litigation
- •Contraindication to rTMS or MRI (seismotherapy treatment since the previous month; epilepsy and/or history of epilepsy; history of head trauma; neurosurgical lesion; intracranial hypertension; intracerebral metal clip; piercing; pacemaker; insulin pump; metal prosthesis; pregnant or breast-feeding woman; claustrophobia)
- •Drug or psychoactive substance abuse
- •Neuropathic pain in the context of a progressive pathology (HIV, cancer, systemic disease disease)
- •Presence of other pain more severe than that justifying inclusion
- •Patient unable to understand informed consent
- •Patient unwilling or unable to stop treatments prohibited during the study
- •Patient participating in another research protocol involving a drug within the 30 days prior to inclusion
- •Patient deprived of liberty or under legal protection (guardianship, curatorship, safeguard of justice safeguard, family safeguard)
- •Minor patient
结局指标
主要结局
Comparison of pain relief rates between the two stimulation targets (M1 and DLPFC)
时间窗: 2 weeks after the last rTMS session for each arm
Patients are asked how much pain relief they have experienced since the last session.
次要结局
- Evolution of catastrophism(2 weeks after rTMS sessions)
- Change in perceived quality of life(2 weeks after rTMS sessions)
- Evolution of affective and sensory components of pain(2 weeks after rTMS sessions)
- Pain evolution(Up to 26 weeks)
- Neuropathic dimension(Up to 26 weeks)
- Progression of depression (Beck Depression Inventory - BDI)(2 weeks after rTMS sessions)
- Progression of depression (Montgomery Asberg Depression Rating Scale - MADRS)(2 weeks after rTMS sessions)
- Changes in mean pain intensity(2 weeks after rTMS sessions)
- Adverse events(Up to 26 weeks)