Brain Connectome for Acupuncture-treated Migraine Patients
关键词
抽象
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.
日期
| 最后验证: | 01/31/2019 |
| 首次提交: | 11/05/2019 |
| 提交的预估入学人数: | 11/05/2019 |
| 首次发布: | 11/07/2019 |
| 上次提交的更新: | 02/05/2020 |
| 最近更新发布: | 02/06/2020 |
| 实际学习开始日期: | 03/31/2020 |
| 预计主要完成日期: | 09/30/2020 |
| 预计完成日期: | 05/31/2021 |
状况或疾病
干预/治疗
Other: Patients receiving real acupuncture treatment
Other: Patients receiving sham acupuncture treatment
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Patients receiving real acupuncture treatment Treatment with needle insertion | Other: Patients receiving real acupuncture treatment The patient will be treated for migraine with real acupuncture. |
| Sham Comparator: Patients receiving sham acupuncture treatment Treatment without needle insertion | Other: Patients receiving sham acupuncture treatment Sham acupuncture is used as a control in scientific studies to test the efficacy of acupuncture in the treatment of various disorders, in this case, migraine. In this study, the subjects will not know whether they are getting true acupuncture or not. In the placebo group, the acupuncture needles will not actually be inserted into the skin. Placebo needles consisting of a sliding tube and a retractible needle are applied to the acupunture reference point (marked by a pastille stuck on the skin). The patient should not be able to feel the difference between real acupuncture and sham acupuncture. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
结果
主要结果指标
1. Regional homogeneity map in Interventional group patients BEFORE first real acupuncture session. [At the inclusion visit (Vinc) on Day 0 - Start of therapy]
2. Regional homogeneity map in Interventional group patients AFTER first real acupuncture session. [At the inclusion visit (Vinc) on Day 0 - Start of therapy]
3. Regional homogeneity map in Placebo group patients BEFORE first real acupuncture session. [At the inclusion visit (Vinc) on Day 0 - Start of therapy]
4. Regional homogeneity map in Placebo group patients AFTER first real acupuncture session. [At the inclusion visit (Vinc) on Day 0 - Start of therapy]
5. Regional homogeneity map in Interventional group patients BEFORE last real acupuncure session [Sixty days after inclusion in the trial (Day 60) - end of therapy]
6. Regional homogeneity map in Interventional group patients AFTER last real acupuncure session [Sixty days after inclusion in the trial (Day 60) - end of therapy]
7. Regional homogeneity map of Placebo group patients BEFORE last placebo acupuncture session [Sixty days after inclusion in the trial (Day 60) - end of therapy]
8. Regional homogeneity map of Placebo group patients AFTER last placebo acupuncture session [Sixty days after inclusion in the trial (Day 60) - end of therapy]
次要成果指标
1. 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]
2. 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]
3. 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]
4. 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]
5. 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]
6. 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]
7. 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]
8. 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]
9. 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]
10. 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]
11. 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]
12. 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]
13. 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]
14. 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]
15. 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]
16. 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]
17. 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]
18. 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]
19. 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]
20. Fractional anisotropy of the White Matter in Placebo group patients AFTER first placebo acupuncture session [At the inclusion visit (Vinc) on Day 0 - start of therapy]
21. 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]
22. 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]
23. 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]
24. 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]
25. Change in number of days with migraine per month - Interventional group BEFORE treatment [At the inclusion visit (Vinc) on Day 0]
26. Change in number of days with migraine per month - Interventional group AFTER treatment [At the end of the study (on Day 90)]
27. Change in number of days with migraine per month - Placebo group BEFORE treatment [At the inclusion visit (Vinc) on Day 0]
28. Change in number of days with migraine per month - Placebo group AFTER treatment [At the end of the study (on Day 90)]
29. Pain BEFORE treatment in the Interventional group [At the inclusion visit (Vinc) on Day 0]
30. Pain AFTER treatment in the Interventional group [At the end of the study (on Day 90)]
31. Pain BEFORE treatment in the Placebo group [At the inclusion visit (Vinc) on Day 0]
32. Pain AFTER treatment in the Placebo group [At the end of the study (on Day 90)]
33. Impact of migraine on the Interventional group patients' Quality of Life (QOL) BEFORE treatment [At the inclusion visit (Vinc) on Day 0]
34. Impact of migraine on the Interventional group patients' Quality of Life (QOL) AFTER treatment [At the end of the study on Day 90]
35. Impact of migraine on the Placebo group patients' Quality of Life (QOL) BEFORE treatment. [At the inclusion visit (Vinc) on Day 0]
36. Impact of migraine on the Placebo group patients' Quality of Life (QOL) AFTER treatment. [At the end of the study on Day 90]
