Bilateral DLPC tDCS: a New Potential Neuromodulatory Strategy in Drug-resistant Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Headache Impact Test (HIT-6) score
研究概览
简要总结
The goal of this clinical trial is to study and describe the effects of bilateral tDCS applied to dorso-lateral-prefrontal cortex (DLPC) in patients with drug-resistant migraine in terms of reduction in frequency of pain, impact of pain in daily life, quality of sleep and psychological measures. We finally planned to include high frequency and chronic migraine patients.
The main questions it aims to answer are:
- Will bilateral DLPC tDCS be feasible, well tolerated and safe in drug resistant migraine patients?
- Will bilateral DLPC tDCS be effective in reducing pain frequency, intensity and its impact in daily life activities?
- Will bilateral DLPC tDCS be effective in ameliorating sleep and psychological associated symptoms?
- Will bilateral DLPC tDCS be such effective in reducing pain frequency, intensity and its impact in daily life activities as anti-CGRP treatments?
Participants will undergo 2 tDCS sessions daily for 2 consecutive weeks. Patients will be blinded to treatment and will be divided in two groups (real vs placebo). A third group of patients, age-matched to the other two, will undergo anti-CGRP treatment. Patients will be asked to complete Patient-Reported Outcomes (PROMs) scales at baseline, one week after the end of the treatment and at 6 months after the end of the treatment.
Researchers (blinded to the treatment) will compare the group that underwent real tDCS treatment vs the one that underwent placebo tDCS vs the one that underwent anti-CGRP drugs to see if bilateral DLPC tDCS is effective in reducing migraine frequency, intensity and impact and if bilateral DLPC tDCS is such effective as anti-CGRP treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of high-frequency and/or chronic migraines, according to the diagnostic criteria of the ICHD-III,
- •failure to more than 3 preventive drugs
- •stable pharmacological treatment (> 6 months without changes),
- •absence of other neurological or medical pathological conditions,
- •written informed consent.
排除标准
- •significant cognitive impairment that prevents following orders and understanding instructions (Mini-Mental State Examination < 23)
- •pregnancy
- •aphasia or limitations in communication,
- •metallic cranial implants
- •another neurological or psychiatric pathology
- •diagnosis of another type of migraine.
研究组 & 干预措施
Real tDCS
Patients will undergo real tDCS applied to both DLPC. Two daily sessions of 20 minutes each were administered (40 minutes a day in total), with a 5-minutes break in between, 5 days a week (Monday to Friday) and with 20 tDCS sessions in total for participant
干预措施: Transcranial direct current stimulation (tDCS) (Device)
Sham tDCS
Patients will undergo sham tDCS applied to both DLPC. Two daily sessions of 20 minutes each were administered (40 minutes a day in total), with a 5-minutes break in between, 5 days a week (Monday to Friday) and with 20 tDCS sessions in total for participant
干预措施: Transcranial direct current stimulation (tDCS) (Device)
anti-CGRP
Patients will undergo anti-CGRP treatment
干预措施: anti-CGRP-mAbs (Drug)
结局指标
主要结局
Headache Impact Test (HIT-6) score
时间窗: baseline, 2 weeks after the end of the treatment, 6 months
HIT-6 is a tool used to measure the impact headaches have on patient's ability to function on the job, at school, at home and in social situations.
Migraine attacks monthly frequency
时间窗: baseline, 2 weeks after the end of the treatment, 6 months
Patients will report migraine monthly frequency for the 3 different time-points
Pain killer drugs monthly taken
时间窗: baseline, 2 weeks after the end of the treatment, 6 months
Patients will report pain-killer drugs taken during a month for the 3 different time-points
次要结局
- The Pittsburgh Sleep Quality Index (PSQI)(baseline, 2 weeks after the end of the treatment, 6 months)
- Brief Symptom Inventory (BSI)(baseline, 2 weeks after the end of the treatment, 6 months)
研究者
Michele Dileone
MD, PhD, Principal Investigator, Neurologist
Clínica de Intervención en Neurociencias