Brain Connectome for Acupuncture-treated Migraine Patients

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: October 2020

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.

Interventions

  • Other: Real acupuncture
    • The patient will be treated for migraine with real acupuncture.
  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Patients receiving real acupuncture treatment
    • Treatment with needle insertion
  • Sham Comparator: Patients receiving sham acupuncture treatment
    • Treatment without needle insertion

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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 Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nīmes
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anissa MEGZARI, Mme., Study Director, CHU de Nîmes (Nîmes University Hospital)
  • Overall Contact(s)
    • Brigitte DARDALHON, Dr., 06.60.73.83.58, brigitte.dardalhon@chu-nimes.fr

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