Brain Connectome for Migraine Patients Treated Via Acupuncture: A Randomized, Controlled Study Under Single-blind Conditions, With a Placebo Group and Magnetic Resonance Imaging (MRI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Regional homogeneity map in Interventional group patients BEFORE last real acupuncure session
研究概览
简要总结
Acupuncture has been a means of treating headaches and migraine since 2002 and is now a World Health Organisation-recognized prophylactic treatment for migraine. Brain activation/de-activation via acupuncture modifies the haemodynamic responses in the brain which may impact the sensorial, cognitive and affective dimensions of pain. Randomized studies on patients suffering from aura-free migraine have shown that the painkilling effect of regular acupuncture sessions on the cerebral substratum, compared with simulated sham-type acupuncture, can reduce the frequency of bouts of migraine, number of days with headaches and also their intensity.
Modifications to the white matter (WM) and grey matter (GM) occur after repeated sessions of acupuncture treatment for pain and these are observable via magnetic resonance imaging (MRI). It is a very sensitive technique and often used to detect functional and structural brain changes.
详细描述
Since 2002, acupuncture has been employed as a method for treating headaches and migraine. It is recognized by the World Health Organisation (WHO), and is now part of the prophylactic treatments for migraine. Brain activations/de-activation via acupuncture lead to a modification of haemodynamic responses in the brain which may impact the sensorial, cognitive and affective dimensions of pain. Randomized studies on patients who suffer from migraine without aura have shown that the painkilling effect of repeated acupuncture sessions on the cerebral substratum, compared with simulated sham-type acupuncture, make it possible to reduce the frequency of bouts of migraine, the number of days of headaches, and the intensity of the bouts.
Following repeated sessions of acupuncture treatment for pain, modifications occur in the white matter (WM) and in the grey matter (GM) and these may be observed by magnetic resonance imaging (MRI) which is a highly sensitive technique and very often used to detect functional brain changes and/or subtle abnormalities.
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, Outcomes Assessor)
盲法说明
The patient is unaware of the study (and whether he/she is receiving the placebo or not).
The imager is also unaware of whether the patient has had sham or real acupuncture.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients with two to eight bouts of migraine without an aura per month
- •All patient aged (≥) 18 to (≤) 60 years old
- •All patients who have not had a bout of migraine in the last 24 hours
- •All patients who have given free informed consent and have signed the consent form.
- •All patients who are affiliated to or beneficiaries of a health insurance scheme
- •All patients available for a two-month follow-up
排除标准
- •All patients with migraine which is secondary to a neurological, neuropsychiatric, or vascular disorder
- •All patients suffering from diabetes
- •All patients with a past history of alcohol or drug abuse
- •All patients with contraindications for an MRI scan
- •All patients on antidepressants or Botox.
- •All patients already taking part in Category 1 research involving the human person
- •All patients on an exclusion period determined by another study
- •All patients placed under judicial protection, guardianship, or supervision
- •All patients for whom it is impossible to give the subject clear information
- •All patients who are pregnant, about to give birth or breastfeeding
- •All patient who have received botulinum toxin in the past year
- •All patient who have undergone antidepressant treatment in the last 2 months
- •All patient who have started a background migraine treatment for less than 3 months
- •All patient who have more than 14 migraine days per month
研究组 & 干预措施
Patients receiving real acupuncture treatment
Treatment with needle insertion
干预措施: Real acupuncture (Other)
Patients receiving sham acupuncture treatment
Treatment without needle insertion
干预措施: Sham acupuncture (placebo group) (Other)
结局指标
主要结局
Regional homogeneity map in Interventional group patients BEFORE last real acupuncure session
时间窗: Sixty days after inclusion in the trial (Day 60) - end of therapy
Regional homogeneity in patients treated via acupuncture (Interventional group) is is computed with functional magnetic resonance imaging
Regional homogeneity map in Interventional group patients BEFORE first real acupuncture session.
时间窗: At the inclusion visit (Vinc) on Day 0 - Start of therapy
Regional homogeneity in patients treated via real acupuncture (Interventional group) is computed with functional magnetic resonance imaging
Regional homogeneity map in Placebo group patients AFTER first real acupuncture session.
时间窗: At the inclusion visit (Vinc) on Day 0 - Start of therapy
Regional homogeneity in patients treated via simulated, sham-type acupuncture (Placebo group) is computed with functional magnetic resonance imaging
Regional homogeneity map in Interventional group patients AFTER first real acupuncture session.
时间窗: At the inclusion visit (Vinc) on Day 0 - Start of therapy
Regional homogeneity in patients treated via real acupuncture (Interventional group) is computed with functional magnetic resonance imaging
Regional homogeneity map in Placebo group patients BEFORE first real acupuncture session.
时间窗: At the inclusion visit (Vinc) on Day 0 - Start of therapy
Regional homogeneity in patients treated via simulated, sham-type acupuncture (Placebo group) is computed with functional magnetic resonance imaging
Regional homogeneity map in Interventional group patients AFTER last real acupuncure session
时间窗: Sixty days after inclusion in the trial (Day 60) - end of therapy
Regional homogeneity in patients treated via acupuncture (Interventional group) is computed with functional magnetic resonance imaging
Regional homogeneity map of Placebo group patients BEFORE last placebo acupuncture session
时间窗: Sixty days after inclusion in the trial (Day 60) - end of therapy
Regional homogeneity in patients treated via simulated, sham-type acupuncture (Placebo group) is computed with functional magnetic resonance imaging
Regional homogeneity map of Placebo group patients AFTER last placebo acupuncture session
时间窗: Sixty days after inclusion in the trial (Day 60) - end of therapy
Regional homogeneity in patients treated via simulated, sham-type acupuncture (Placebo group) is computed with functional magnetic resonance imaging
次要结局
- Radial diffusivity of the White Matter in Placebo group patients BEFORE first placebo acupuncture session(At the inclusion visit (Vinc) on Day 0 - start of therapy)
- Radial diffusivity of the White Matter in Placebo group patients AFTER first placebo acupuncture session(At the inclusion visit (Vinc) on Day 0 - start of therapy)
- Radial diffusivity of the White Matter in Placebo group patients AFTER last real acupuncture session(60 days after the initial inclusion visit (Day 60) - end of therapy)
- Radial diffusivity of the White Matter in Interventional group patients AFTER first real acupuncture session(At the inclusion visit (Vinc) on Day 0 - start of therapy)
- Fractional anisotropy of the White Matter in Interventional group patients BEFORE last real acupuncture session(60 days after the initial inclusion visit (Day 60) - end of therapy)
- Change in number of days with migraine per month - Interventional group BEFORE treatment(At the inclusion visit (Vinc) on Day 0)
- Change in number of days with migraine per month - Placebo group AFTER treatment(At the end of the study (on Day 90))
- Pain BEFORE treatment in the Placebo group(At the inclusion visit (Vinc) on Day 0)
- Mean diffusivity of White Matter of Interventional group patients BEFORE first real acupuncture session(At the inclusion visit (Vinc) on Day 0 - start of therapy)
- Mean diffusivity of White Matter of Interventional group patients AFTER first real acupuncture session(At the inclusion visit (Vinc) on Day 0 - start of therapy)
- Mean diffusivity of White Matter of Placebo group patients AFTER first placebo acupuncture session(At the inclusion visit (Vinc) on Day 0 - start of therapy)
- Radial diffusivity of the White Matter in Interventional group patients BEFORE last real acupuncture session(60 days after the initial inclusion visit (Day 60) - end of therapy)
- Fractional anisotropy of the White Matter in Interventional group patients AFTER first real acupuncture session(At the inclusion visit (Vinc) on Day 0 - start of therapy)
- Fractional anisotropy of the White Matter in Placebo group patients BEFORE first placebo acupuncture session(At the inclusion visit (Vinc) on Day 0 - start of therapy)
- Fractional anisotropy of the White Matter in Interventional group patients AFTER last real acupuncture session(60 days after the initial inclusion visit (Day 60) - end of therapy)
- Change in number of days with migraine per month - Placebo group BEFORE treatment(At the inclusion visit (Vinc) on Day 0)
- Impact of migraine on the Interventional group patients' Quality of Life (QOL) AFTER treatment(At the end of the study on Day 90)
- Mean diffusivity of White Matter of Placebo group patients BEFORE first placebo acupuncture session(At the inclusion visit (Vinc) on Day 0 - start of therapy)
- Mean diffusivity of White Matter of Interventional group patients AFTER last real acupuncture session(60 days after the initial inclusion visit (Day 60) - end of therapy)
- Mean diffusivity of White Matter of Interventional group patients BEFORE last real acupuncture session(60 days after the initial inclusion visit (Day 60) - end of therapy)
- Mean diffusivity of White Matter of Placebo group patients BEFORE last placebo acupuncture session(60 days after the initial inclusion visit (Day 60) - end of therapy)
- Mean diffusivity of White Matter of Placebo group patients AFTER last placebo acupuncture session(60 days after the initial inclusion visit (Day 60) - end of therapy)
- Radial diffusivity of the White Matter in Interventional group patients BEFORE first real acupuncture session(At the inclusion visit (Vinc) on Day 0 - start of therapy)
- Radial diffusivity of the White Matter in Interventional group patients BEFORE last placebo acupuncture session(60 days after the initial inclusion visit (Day 60) - end of therapy)
- Fractional anisotropy of the White Matter in Placebo group patients AFTER first placebo acupuncture session(60 days after the initial inclusion visit (Day 60) - end of therapy)
- Radial diffusivity of the White Matter in Placebo group patients AFTER last placebo acupuncture session(60 days after the initial inclusion visit (Day 60) - end of therapy)
- Fractional anisotropy of the White Matter in Interventional group patients BEFORE first real acupuncture session(At the inclusion visit (Vinc) on Day 0 - start of therapy)
- Fractional anisotropy of the White Matter in Placebo group patients BEFORE last placebo acupuncture session(60 days after the initial inclusion visit (Day 60) - end of therapy)
- Change in number of days with migraine per month - Interventional group AFTER treatment(At the end of the study (on Day 90))
- Pain AFTER treatment in the Interventional group(At the end of the study (on Day 90))
- Pain AFTER treatment in the Placebo group(At the end of the study (on Day 90))
- Impact of migraine on the Placebo group patients' Quality of Life (QOL) AFTER treatment.(At the end of the study on Day 90)
- Pain BEFORE treatment in the Interventional group(At the inclusion visit (Vinc) on Day 0)
- Impact of migraine on the Interventional group patients' Quality of Life (QOL) BEFORE treatment(At the inclusion visit (Vinc) on Day 0)
- Impact of migraine on the Placebo group patients' Quality of Life (QOL) BEFORE treatment.(At the inclusion visit (Vinc) on Day 0)