Comparison of Neuromodulatory Treatment of Migraine Headache with Acupuncture and Transcranial Direct Current Stimulation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of days with migraine headache per month
研究概览
简要总结
The goal of this clinical trial is to compare effects of the treatment with acupuncture and transcranial direct current stimulation (tDCS) in patients with migraine headache. The main questions it aims to answer are:
- is tDCS more effective than acupuncture/placebo?
- is there any difference in venous blood inflammatory parameters (CGRP (calcitonin gene related peptide), IL (interleukine) -6, IL-8. IL-10, SAA (serum amyloid A) and ESR (erythrocyte sedimentation rate) before/after treatment?
- could these inflammatory parameters function as biomarkers of disease and/or indicators of treatment's efficacy?
Participants will regularly fill out questionnaires (migraine diary) and their venous blood before/after treatment will be taken for analysis.
Researchers will compare the effects of sham and verus treatment of both methods before and after 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •4 migraine days per month
- •no acupuncture in the past
- •understanding of study design and ability to give informed consent
排除标准
- •severe psychiatric disorders
- •pacemaker
- •status post brain surgery with open skull
- •brain stimulators
- •metal implants
- •biologic drugs
- •pregnancy
研究组 & 干预措施
Sham Acupuncture
Patients receive sham acupuncture (skin remains intact, away from standard acupuncture points)
干预措施: Acupuncture (Procedure)
Verus Acupuncture
Patients receive acupuncture treatment over semistandardized acupuncture points for migraine headache.
干预措施: Acupuncture (Procedure)
Sham tDCS
Device will provide only placebo stimulation (study mode)
干预措施: Transcranial direct current stimulation (Device)
verus tDCS
Device will stimulate with direct current (study mode)
干预措施: Transcranial direct current stimulation (Device)
结局指标
主要结局
Number of days with migraine headache per month
时间窗: 4 months
Evaluation of migraine days before study, at 1 nad 3 months after comleted therapy.
次要结局
- Change of inflammatory parameters(4 months)
- Severity of migraine headache(4 months)
研究者
Alenka Spindler-Vesel
MD, PhD, Principal Investigator
University Medical Centre Ljubljana