Anodal Transcranial Direct Current Stimulation in Chronic Migraine With and Medication Overuse Headache: a Pilot Randomized Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Headache frequency
研究概览
简要总结
Non-invasive neuromodulation has been applied in several forms of primary headaches, and its usefulness has been suggested for both episodic and chronic migraine (CM). Transcranial direct current stimulation (tDCS) represents a non-invasive electrical stimulation technique that modulates neural brain activity by means of low amplitude direct current trough surface electrodes.
Very little evidence is available on the potential effect of tDCS in medication overuse and in the management of medication overuse headache (MOH), a condition frequently associated to CM.
CM associated to MOH still represents a challenge for physicians and patients due to the high prevalence in the general population, the associated severe disability, and the high costs imposed by the treatment.
The aim of the study was to investigate the possible application of tDCS in the management of CM associated to MOH. The primary objective of this pilot study was therefore to investigate the efficacy of anodal tDCS delivered on the primary motor cortex (M1) as add-on therapy to an in-hospital detoxification protocol in subjects affected by CM and MOH. The secondary objective was to evaluate the possible changes induced by tDCS on conventional EEG in order to obtain further clues about the effects of tDCS on brain activity.
详细描述
The study was a randomized, double-blind, controlled trial aimed at assessing the efficacy of five daily sessions of anodal t-DCS in add-on to a standardized in-hospital detoxification protocol in patients suffering from CM+MOH.
Twenty patients were enrolled among those consecutively attending the outpatient clinic of the IRCCS Mondino Foundation. All subjects underwent a screening visit with a physician of the Headache Science Centre of Mondino Institute. During the screening visit, a complete neurological and general examination was performed , and the inclusion/exclusion criteria were revised. Patients fulfilling criteria were enrolled in the baseline observation period for a month after an adequate training to monitor and record migraine and headache days, type and amount of acute medications and days of acute drug intake in an ad hoc diary. At the end of the baseline observation period, if inclusion/exclusion criteria were still satisfied, patients were randomized to the double-blind phase of the study (T0). To this end, patients were hospitalized on Mondays at the IRCCS Mondino Foundation for a 7-day detoxification protocol, that included: acute withdrawal of the overused drug and e.v. treatment with isotonic 0.9% NaCl saline 500 ml + cyanocobalamin 2500 mcg + folic acid 0.70 mg + nicotinamide 12 mg + ascorbic acid 150 mg + sodic glutathione 600 mg + delorazepam 0.5 mg administered b.i.d.
The day of hospital admission (T0), before the first infusion, patients were tested with a complete set of clinical scales and they completed the baseline EEG recording. After these procedures, the patients were randomized (1:1) to two different treatment groups: "tDCS group" or "sham group" and received 1 daily session of tDCS/sham stimulation for 5 consequent days (see below).
On day 5 (T1) patients underwent a follow-up EEG recording, administration of clinic scales for sleepiness, and attentional functions, evaluation of adverse events.
On day 7 patients were discharged from the hospital with or without the prescription of preventive medication (based on the physician judgement) and returned for a follow-up visit after 1 month (T2) and 6 months (T3). An addition EEG recording was obtained at T2.
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)
盲法说明
Transcranial direct current stimulation (tDCS) was delivered by a technician that was not otherwise involved in the management of patients. The managing physician and the patient were instead blind to the type of stimulation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 to 65 years;
- •chronic migraine according to the criteria of the InternationaI Classification of Headache Disorders (code 1.3 ICHD-III) and Medication Overuse Headache (code 8.2 ICHD-III) present for at least 6 months at inclusion;
- •previous failure of at least three prophylactic treatments.
排除标准
- •other neurologic or neuropsychiatric diseases;
- •other chronic painful syndromes;
- •other types of primary or secondary headaches;
- •use of a preventive medication at baseline;
- •use of central nervous system modulating drugs;
- •epilepsy;
- •metallic head implants or use of a cardiac pacemaker;
- •pregnancy or lactation.
结局指标
主要结局
Headache frequency
时间窗: Change in number of migraine days from T0 (baseline) to T2 (1 month after hospital discharge)
Headache frequency measured by number of migraine days per month recorded in a headache diary.
次要结局
- Migraine Disability Assessment (MIDAS)(Baseline (T0), after 1 month from hospital discharge (T2))
- Headache Impact Test-6 (HIT-6).(Baseline (T0), after 1 month from hospital discharge (T2))
- Visual Analogue Scale (VAS)(Baseline (T0), after 1 month from hospital discharge (T2))
- Zung scale for anxiety(Baseline (T0), after 1 month from hospital discharge (T2))
- Pittsburgh Sleep Quality Index (PSQI)(Baseline (T0), after 1 month from hospital discharge (T2))
- Zung scale for depression(Baseline (T0), after 1 month from hospital discharge (T2))
- Sleep Condition Indicator (SCI)(Baseline (T0), after 1 month from hospital discharge (T2))
- EEG power spectrum (µV2) of theta frequencies(Percentage modification of EEG power spectrum of theta frequencies from T0 (baseline) to T2 (1 month after hospital discharge))
- Migraine-Specific Quality-of-Life Questionnaire (MSQ)(Baseline (T0), after 1 month from hospital discharge (T2))
- Short Form Health Survey (SF-36).(Baseline (T0), after 1 month from hospital discharge (T2))
- EEG power spectrum (µV2) of alpha frequencies(Percentage modification of EEG power spectrum of alpha frequencies from T0 (baseline) to T2 (1 month after hospital discharge))
- EEG power spectrum (µV2) of beta frequencies(Percentage modification of EEG power spectrum of beta frequencies from T0 (baseline) to T2 (1 month after hospital discharge))
- EEG power spectrum (µV2) of delta frequencies(Percentage modification of EEG power spectrum of delta frequencies from T0 (baseline) to T2 (1 month after hospital discharge))