Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline in moderate to severe headache days over 1 month follow-up
研究概览
简要总结
This study investigates whether unilateral and bilateral non-invasive brain stimulation, given for 20 minutes/once per day for twenty days (M-F) can reduce migraine pain. Fourty patients will receive treatment (20 unilateral treatment, and 20 bilateral treatment), while twenty will receive a "sham" procedure. Another 20 Episodic Migraine patients will be recruited for the observational aim of the study which does not include brain stimulation.
详细描述
Clinical Trial:
This is a phase 2, single center, three-arm, double-masked, randomized investigation and modulation of the µ-opioid and D2/D3 mechanisms in chronic migraine (in vivo). We will enroll 60 patients with Chronic Migraine divided into 3 Lab/Home-Based groups: 20 for the active unilateral M11-2 HD-tDCS group, 20 for the active bilateral M11-2 HD-tDCS group, and 20 for the sham M11-2 HD-tDCS group. Patients will complete a screening visit, baseline visit with MRI and PET session, 20 days of HD-tDCS brain stimulation treatments, as well as follow-up visits with an MRI and PET session.
Observational Study Arm:
20 additional patients with low frequency EM (<8 attacks/month) patients (that did not undergo neuromodulation) will be recruited for the study. Historical data may be used in place of recruiting new participants. Data from these 20 EM volunteers will be compared to that of CM patients at baseline; however, they will not be part of the clinical trial.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients will not know if they are receiving active or sham treatment
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
- •Male or female, aged 18 to 65 (inclusive)
- •Patients must have Episodic migraines that started before the age of 50, and currently experience:
- •Chronic migraine (ICHD-3-beta), headache occurring on 15 days/month for more than six months, which, on at least eight days/month, has the features of a migraine headache.
- •Episodic migraine (low frequency), specifically those with headache occurring less than 8 days/month.
- •Willing to limit the introduction of new treatments and medications during the study period.
排除标准
- •Significantly greater pain in body sites other than the head
- •Active, untreated major concurrent systemic illness other than migraine
- •Medical conditions that can impair health status independent of migraine (including cardiopulmonary disorders, malignancy, uncontrolled endocrine or allergies)
- •Systemic rheumatic disorders (i.e., rheumatoid arthritis, systemic lupus erythematosus, gout, and fibromyalgia);
- •History or current evidence of a psychotic disorder (e.g., bipolar disorder, schizophrenia) or severe major depression, as evidenced by Beck Depression score of >30*
- •History of neurological disorder (e.g., epilepsy, stroke, neuropathy, neuropathic pain)
- •Medication overuse headache (ICHD-3), regular intake for ≥10 days per month of ergotamine, triptans, combination analgesics, or any combination thereof OR ≥15 days per month of simple analgesics (acetaminophen, aspirin, NSAID), for more than 3 months
- •Current use of opioid or dopaminergic drugs (or use within the last 3 months) or substance abuse (self-reported)
- •Drug test positive for opioid or recreational drug (e.g., cannabis) at the time of the PET scan visits
- •Allergic response to study radiotracers or chemically related drugs
- •Excluded by MRI Center or PET Center safety screening checklist (as administered by study staff)
- •Pregnant or lactating (negative urine pregnancy test must be available before any PET procedures are initiated)
- •Prior use of tDCS
研究组 & 干预措施
Active Unilateral Treatment
Chronic migraine patients will be randomized (Taves method) to receive UNILATERAL high-definition transcranial direct current stimulation (HD-tDCS*) as 20 minute sessions, once daily for 20 days (M-F for 4 weeks).
干预措施: HD-tDCS Active Protocol (Device)
Active Bilateral Treatment
Chronic migraine patients will be randomized (Taves method) to receive BILATERAL high-definition transcranial direct current stimulation (HD-tDCS*) as 20 minute sessions, once daily for 20 days (M-F for 4 weeks).
干预措施: HD-tDCS Active Protocol (Device)
Sham Treatment
Chronic migraine patients will be randomized (Taves method) to receive SHAM high-definition transcranial direct current stimulation (HD-tDCS*) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 20 days (M-F for 4 weeks).
干预措施: HD-tDCS Sham Protocol (Device)
No Treatment
Episodic Migraine Patients will not receive study treatment. These patients will complete observational study components (Screening visit, baseline visit, MRI and PET scan only).
结局指标
主要结局
Change from baseline in moderate to severe headache days over 1 month follow-up
时间窗: baseline to 1 month follow-up
Headache Day: day with a headache that causes moderate or severe pain (at its peak, defined as NRS ≥ 4) that lasts at least 4 hours, OR day with a headache that is treated by an acute headache medication.
次要结局
- Intensity of headache over 1-month follow-up(baseline to 1 month follow-up)
- Responder rate over 1-month follow-up(baseline to 1 month follow-up)
- Change from baseline in headache days over 1-month follow-up(baseline to 1 month follow-up)
- Changes from baseline in medication use days over 1-month follow-up(baseline to 1 month follow-up)
研究者
Alexandre DaSilva, DDS, DMedSc
Director of the Headache and Orafacial Pain Effort Lab
University of Michigan