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Brain Connectome for Acupuncture-treated Migraine Patients (ACU-BRAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04157192
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Migraine Without Aura Acupuncture Therapy Other: Real acupuncture Other: Sham acupuncture (placebo group) Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 40 patients will be randomly assigned to one of two groups (1) The Interventional Group: 20 Patients will receive 5 real acupuncture sessions each spaced 15 days apart. At the first and last sessions of acupuncture, an MRI scan will be performed before and after the acupuncture session and (2) The Placebo Group : 20 patients will receive 5 sham sessions of acupuncture (i.e. using a simulated acupuncture technique) each spaced 15 days apart. At the first and last sham sessions, an MRI scan will be performed before and after the sham acupuncture session.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: 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)
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Migraine

Arm Intervention/treatment
Active Comparator: Patients receiving real acupuncture treatment
Treatment with needle insertion
Other: Real acupuncture
The patient will be treated for migraine with real acupuncture.

Sham Comparator: Patients receiving sham acupuncture treatment
Treatment without needle insertion
Other: Sham acupuncture (placebo group)
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.




Primary Outcome Measures :
  1. Regional homogeneity map in Interventional group patients BEFORE first real acupuncture session. [ Time Frame: 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

  2. Regional homogeneity map in Interventional group patients AFTER first real acupuncture session. [ Time Frame: 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

  3. Regional homogeneity map in Placebo group patients BEFORE first real acupuncture session. [ Time Frame: 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

  4. Regional homogeneity map in Placebo group patients AFTER first real acupuncture session. [ Time Frame: 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

  5. Regional homogeneity map in Interventional group patients BEFORE last real acupuncure session [ Time Frame: 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

  6. Regional homogeneity map in Interventional group patients AFTER last real acupuncure session [ Time Frame: 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

  7. Regional homogeneity map of Placebo group patients BEFORE last placebo acupuncture session [ Time Frame: 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

  8. Regional homogeneity map of Placebo group patients AFTER last placebo acupuncture session [ Time Frame: 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


Secondary Outcome Measures :
  1. Mean diffusivity of White Matter of Interventional group patients BEFORE first real acupuncture session [ Time Frame: At the inclusion visit (Vinc) on Day 0 - start of therapy ]
    The mean diffusivity of White Matter of Interventional group patients is computed with diffusion-weighted magnetic resonance imaging

  2. Mean diffusivity of White Matter of Interventional group patients AFTER first real acupuncture session [ Time Frame: At the inclusion visit (Vinc) on Day 0 - start of therapy ]
    The mean diffusivity of White Matter of Interventional group patients is computed with diffusion-weighted magnetic resonance imaging

  3. Mean diffusivity of White Matter of Placebo group patients BEFORE first placebo acupuncture session [ Time Frame: At the inclusion visit (Vinc) on Day 0 - start of therapy ]
    The mean diffusivity of White Matter of Placebo group patients is computed with diffusion-weighted magnetic resonance imaging

  4. Mean diffusivity of White Matter of Placebo group patients AFTER first placebo acupuncture session [ Time Frame: At the inclusion visit (Vinc) on Day 0 - start of therapy ]
    The mean diffusivity of White Matter of Placebo group patients is computed with diffusion-weighted magnetic resonance imaging

  5. Mean diffusivity of White Matter of Interventional group patients BEFORE last real acupuncture session [ Time Frame: 60 days after the initial inclusion visit (Day 60) - end of therapy ]
    The mean diffusivity of White Matter in patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging

  6. Mean diffusivity of White Matter of Interventional group patients AFTER last real acupuncture session [ Time Frame: 60 days after the initial inclusion visit (Day 60) - end of therapy ]
    The mean diffusivity of White Matter in patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging

  7. Mean diffusivity of White Matter of Placebo group patients BEFORE last placebo acupuncture session [ Time Frame: 60 days after the initial inclusion visit (Day 60) - end of therapy ]
    The mean diffusivity of White Matter in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging

  8. Mean diffusivity of White Matter of Placebo group patients AFTER last placebo acupuncture session [ Time Frame: 60 days after the initial inclusion visit (Day 60) - end of therapy ]
    The mean diffusivity of White Matter in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging

  9. Radial diffusivity of the White Matter in Interventional group patients BEFORE first real acupuncture session [ Time Frame: At the inclusion visit (Vinc) on Day 0 - start of therapy ]
    Radial diffusivity of the White Matter of Interventional group patients is computed with diffusion-weighted magnetic resonance imaging

  10. Radial diffusivity of the White Matter in Interventional group patients AFTER first real acupuncture session [ Time Frame: At the inclusion visit (Vinc) on Day 0 - start of therapy ]
    Radial diffusivity of the White Matter in the Interventional group patients is computed with diffusion-weighted magnetic resonance imaging

  11. Radial diffusivity of the White Matter in Placebo group patients BEFORE first placebo acupuncture session [ Time Frame: At the inclusion visit (Vinc) on Day 0 - start of therapy ]
    Radial diffusivity of the White Matter in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging

  12. Radial diffusivity of the White Matter in Placebo group patients AFTER first placebo acupuncture session [ Time Frame: At the inclusion visit (Vinc) on Day 0 - start of therapy ]
    Radial diffusivity of the White Matter in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging

  13. Radial diffusivity of the White Matter in Interventional group patients BEFORE last real acupuncture session [ Time Frame: 60 days after the initial inclusion visit (Day 60) - end of therapy ]
    Radial diffusivity of the White Matter in patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging

  14. Radial diffusivity of the White Matter in Placebo group patients AFTER last real acupuncture session [ Time Frame: 60 days after the initial inclusion visit (Day 60) - end of therapy ]
    Radial diffusivity of the White Matter in patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging

  15. Radial diffusivity of the White Matter in Interventional group patients BEFORE last placebo acupuncture session [ Time Frame: 60 days after the initial inclusion visit (Day 60) - end of therapy ]
    Radial diffusivity of the White Matter in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging

  16. Radial diffusivity of the White Matter in Placebo group patients AFTER last placebo acupuncture session [ Time Frame: 60 days after the initial inclusion visit (Day 60) - end of therapy ]
    Radial diffusivity of the White Matter in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging

  17. Fractional anisotropy of the White Matter in Interventional group patients BEFORE first real acupuncture session [ Time Frame: At the inclusion visit (Vinc) on Day 0 - start of therapy ]
    Fractional anisotropy of patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging

  18. Fractional anisotropy of the White Matter in Interventional group patients AFTER first real acupuncture session [ Time Frame: At the inclusion visit (Vinc) on Day 0 - start of therapy ]
    Fractional anisotropy of patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging

  19. Fractional anisotropy of the White Matter in Placebo group patients BEFORE first placebo acupuncture session [ Time Frame: At the inclusion visit (Vinc) on Day 0 - start of therapy ]
    Fractional anisotropy in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging

  20. Fractional anisotropy of the White Matter in Placebo group patients AFTER first placebo acupuncture session [ Time Frame: At the inclusion visit (Vinc) on Day 0 - start of therapy ]
    Fractional anisotropy in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging

  21. Fractional anisotropy of the White Matter in Interventional group patients BEFORE last real acupuncture session [ Time Frame: 60 days after the initial inclusion visit (Day 60) - end of therapy ]
    Fractional anisotropy in patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging

  22. Fractional anisotropy of the White Matter in Interventional group patients AFTER last real acupuncture session [ Time Frame: 60 days after the initial inclusion visit (Day 60) - end of therapy ]
    Fractional anisotropy in patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging

  23. Fractional anisotropy of the White Matter in Placebo group patients BEFORE last placebo acupuncture session [ Time Frame: 60 days after the initial inclusion visit (Day 60) - end of therapy ]
    Fractional anisotropy in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging

  24. Fractional anisotropy of the White Matter in Placebo group patients AFTER first placebo acupuncture session [ Time Frame: 60 days after the initial inclusion visit (Day 60) - end of therapy ]
    Fractional anisotropy in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging

  25. Change in number of days with migraine per month - Interventional group BEFORE treatment [ Time Frame: At the inclusion visit (Vinc) on Day 0 ]
    The number of days with migraine per month will be measured according to the days noted on a calendar

  26. Change in number of days with migraine per month - Interventional group AFTER treatment [ Time Frame: At the end of the study (on Day 90) ]
    The number of days with migraine per month will be measured according to the days noted on a calendar

  27. Change in number of days with migraine per month - Placebo group BEFORE treatment [ Time Frame: At the inclusion visit (Vinc) on Day 0 ]
    The number of days with migraine per month will be measured according to the days noted on a calendar

  28. Change in number of days with migraine per month - Placebo group AFTER treatment [ Time Frame: At the end of the study (on Day 90) ]
    The number of days with migraine per month will be measured according to the days noted on a calendar

  29. Pain BEFORE treatment in the Interventional group [ Time Frame: At the inclusion visit (Vinc) on Day 0 ]
    The change in pain will be measured according to the Visual Analogue Scale (VAS) described by Huskisson. The VAS is a simple numerical scale for measuring the intensity of pain. It is represented in the form of a 100 mm continuous line ranging from "Absence of pain" (0 mm) to "Maximum Imaginable Pain" (100 mm). The patient slides the cursor to give the intensity of pain that he/she feels. The amount of pain felt will be reported on the migraine calendar.

  30. Pain AFTER treatment in the Interventional group [ Time Frame: At the end of the study (on Day 90) ]
    The change in pain will be measured according to the Visual Analogue Scale (VAS) described by Huskisson. The VAS is a simple numerical scale for measuring the intensity of pain. It is represented in the form of a 100 mm continuous line ranging from "Absence of pain" (0 mm) to "Maximum Imaginable Pain" (100 mm). The patient slides the cursor to give the intensity of pain that he/she feels. The amount of pain felt will be reported on the migraine calendar.

  31. Pain BEFORE treatment in the Placebo group [ Time Frame: At the inclusion visit (Vinc) on Day 0 ]
    The change in pain will be measured according to the Visual Analogue Scale (VAS) described by Huskisson. The VAS is a simple numerical scale for measuring the intensity of pain. It is represented in the form of a 100 mm continuous line ranging from "Absence of pain" (0 mm) to "Maximum Imaginable Pain" (100 mm). The patient slides the cursor to give the intensity of pain that he/she feels. The amount of pain felt will be reported on the migraine calendar.

  32. Pain AFTER treatment in the Placebo group [ Time Frame: At the end of the study (on Day 90) ]
    The change in pain will be measured according to the Visual Analogue Scale (VAS) described by Huskisson. The VAS is a simple numerical scale for measuring the intensity of pain. It is represented in the form of a 100 mm continuous line ranging from "Absence of pain" (0 mm) to "Maximum Imaginable Pain" (100 mm). The patient slides the cursor to give the intensity of pain that he/she feels. The amount of pain felt will be reported on the migraine calendar.

  33. Impact of migraine on the Interventional group patients' Quality of Life (QOL) BEFORE treatment [ Time Frame: At the inclusion visit (Vinc) on Day 0 ]
    The evolution of the impact of migraine on the patient's Quality of Life (QOL) before and after treatment will be measured on a score of 36 to 78 points by means of the Headache Impact Test-6 (HIT-6). This is a tool used to measure the impact of headaches on the patient's ability to function at work, at school, at home and in social situations.

  34. Impact of migraine on the Interventional group patients' Quality of Life (QOL) AFTER treatment [ Time Frame: At the end of the study on Day 90 ]
    The evolution of the impact of migraine on the patient's Quality of Life (QOL) before and after treatment will be measured on a score of 36 to 78 points by means of the Headache Impact Test-6 (HIT-6). This is a tool used to measure the impact of headaches on the patient's ability to function at work, at school, at home and in social situations.

  35. Impact of migraine on the Placebo group patients' Quality of Life (QOL) BEFORE treatment. [ Time Frame: At the inclusion visit (Vinc) on Day 0 ]
    The evolution of the impact of migraine on the patient's Quality of Life (QOL) before and after treatment will be measured on a score of 36 to 78 points by means of the Headache Impact Test-6 (HIT-6). This is a tool used to measure the impact of headaches on the patient's ability to function at work, at school, at home and in social situations.

  36. Impact of migraine on the Placebo group patients' Quality of Life (QOL) AFTER treatment. [ Time Frame: At the end of the study on Day 90 ]
    The evolution of the impact of migraine on the patient's Quality of Life (QOL) before and after treatment will be measured on a score of 36 to 78 points by means of the Headache Impact Test-6 (HIT-6). This is a tool used to measure the impact of headaches on the patient's ability to function at work, at school, at home and in social situations.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157192


Contacts
Layout table for location contacts
Contact: Brigitte DARDALHON, Dr. 06.60.73.83.58 brigitte.dardalhon@chu-nimes.fr
Contact: Fabricio PEREIRA, Dr. 07.85.92.64.02 fabricio.pereira@umontpellier.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Layout table for investigator information
Study Director: Anissa MEGZARI, Mme. CHU de Nîmes (Nîmes University Hospital)

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04157192     History of Changes
Other Study ID Numbers: RCB : 2019-A00588-49
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Acupuncture
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases