search
Back to results

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

Primary Purpose

Migraine Without Aura, Acupuncture Therapy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Real acupuncture
Sham acupuncture (placebo group)
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Without Aura focused on measuring Acupuncture

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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
  • 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

Sites / Locations

  • Marc FREARDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Patients receiving real acupuncture treatment

Patients receiving sham acupuncture treatment

Arm Description

Treatment with needle insertion

Treatment without needle insertion

Outcomes

Primary Outcome Measures

Regional homogeneity map in Interventional group patients BEFORE first real acupuncture session.
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.
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.
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.
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
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
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
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
Regional homogeneity in patients treated via simulated, sham-type acupuncture (Placebo group) is computed with functional magnetic resonance imaging

Secondary Outcome Measures

Mean diffusivity of White Matter of Interventional group patients BEFORE first real acupuncture session
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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.

Full Information

First Posted
November 6, 2019
Last Updated
April 14, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
search

1. Study Identification

Unique Protocol Identification Number
NCT04157192
Brief Title
Brain Connectome for Acupuncture-treated Migraine Patients
Acronym
ACU-BRAIN
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Without Aura, Acupuncture Therapy
Keywords
Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients receiving real acupuncture treatment
Arm Type
Active Comparator
Arm Description
Treatment with needle insertion
Arm Title
Patients receiving sham acupuncture treatment
Arm Type
Sham Comparator
Arm Description
Treatment without needle insertion
Intervention Type
Other
Intervention Name(s)
Real acupuncture
Intervention Description
The patient will be treated for migraine with real acupuncture.
Intervention Type
Other
Intervention Name(s)
Sham acupuncture (placebo group)
Intervention Description
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 Measure Information:
Title
Regional homogeneity map in Interventional group patients BEFORE first real acupuncture session.
Description
Regional homogeneity in patients treated via real acupuncture (Interventional group) is computed with functional magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - Start of therapy
Title
Regional homogeneity map in Interventional group patients AFTER first real acupuncture session.
Description
Regional homogeneity in patients treated via real acupuncture (Interventional group) is computed with functional magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - Start of therapy
Title
Regional homogeneity map in Placebo group patients BEFORE first real acupuncture session.
Description
Regional homogeneity in patients treated via simulated, sham-type acupuncture (Placebo group) is computed with functional magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - Start of therapy
Title
Regional homogeneity map in Placebo group patients AFTER first real acupuncture session.
Description
Regional homogeneity in patients treated via simulated, sham-type acupuncture (Placebo group) is computed with functional magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - Start of therapy
Title
Regional homogeneity map in Interventional group patients BEFORE last real acupuncure session
Description
Regional homogeneity in patients treated via acupuncture (Interventional group) is is computed with functional magnetic resonance imaging
Time Frame
Sixty days after inclusion in the trial (Day 60) - end of therapy
Title
Regional homogeneity map in Interventional group patients AFTER last real acupuncure session
Description
Regional homogeneity in patients treated via acupuncture (Interventional group) is computed with functional magnetic resonance imaging
Time Frame
Sixty days after inclusion in the trial (Day 60) - end of therapy
Title
Regional homogeneity map of Placebo group patients BEFORE last placebo acupuncture session
Description
Regional homogeneity in patients treated via simulated, sham-type acupuncture (Placebo group) is computed with functional magnetic resonance imaging
Time Frame
Sixty days after inclusion in the trial (Day 60) - end of therapy
Title
Regional homogeneity map of Placebo group patients AFTER last placebo acupuncture session
Description
Regional homogeneity in patients treated via simulated, sham-type acupuncture (Placebo group) is computed with functional magnetic resonance imaging
Time Frame
Sixty days after inclusion in the trial (Day 60) - end of therapy
Secondary Outcome Measure Information:
Title
Mean diffusivity of White Matter of Interventional group patients BEFORE first real acupuncture session
Description
The mean diffusivity of White Matter of Interventional group patients is computed with diffusion-weighted magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - start of therapy
Title
Mean diffusivity of White Matter of Interventional group patients AFTER first real acupuncture session
Description
The mean diffusivity of White Matter of Interventional group patients is computed with diffusion-weighted magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - start of therapy
Title
Mean diffusivity of White Matter of Placebo group patients BEFORE first placebo acupuncture session
Description
The mean diffusivity of White Matter of Placebo group patients is computed with diffusion-weighted magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - start of therapy
Title
Mean diffusivity of White Matter of Placebo group patients AFTER first placebo acupuncture session
Description
The mean diffusivity of White Matter of Placebo group patients is computed with diffusion-weighted magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - start of therapy
Title
Mean diffusivity of White Matter of Interventional group patients BEFORE last real acupuncture session
Description
The mean diffusivity of White Matter in patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
60 days after the initial inclusion visit (Day 60) - end of therapy
Title
Mean diffusivity of White Matter of Interventional group patients AFTER last real acupuncture session
Description
The mean diffusivity of White Matter in patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
60 days after the initial inclusion visit (Day 60) - end of therapy
Title
Mean diffusivity of White Matter of Placebo group patients BEFORE last placebo acupuncture session
Description
The mean diffusivity of White Matter in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
60 days after the initial inclusion visit (Day 60) - end of therapy
Title
Mean diffusivity of White Matter of Placebo group patients AFTER last placebo acupuncture session
Description
The mean diffusivity of White Matter in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
60 days after the initial inclusion visit (Day 60) - end of therapy
Title
Radial diffusivity of the White Matter in Interventional group patients BEFORE first real acupuncture session
Description
Radial diffusivity of the White Matter of Interventional group patients is computed with diffusion-weighted magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - start of therapy
Title
Radial diffusivity of the White Matter in Interventional group patients AFTER first real acupuncture session
Description
Radial diffusivity of the White Matter in the Interventional group patients is computed with diffusion-weighted magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - start of therapy
Title
Radial diffusivity of the White Matter in Placebo group patients BEFORE first placebo acupuncture session
Description
Radial diffusivity of the White Matter in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - start of therapy
Title
Radial diffusivity of the White Matter in Placebo group patients AFTER first placebo acupuncture session
Description
Radial diffusivity of the White Matter in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - start of therapy
Title
Radial diffusivity of the White Matter in Interventional group patients BEFORE last real acupuncture session
Description
Radial diffusivity of the White Matter in patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
60 days after the initial inclusion visit (Day 60) - end of therapy
Title
Radial diffusivity of the White Matter in Placebo group patients AFTER last real acupuncture session
Description
Radial diffusivity of the White Matter in patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
60 days after the initial inclusion visit (Day 60) - end of therapy
Title
Radial diffusivity of the White Matter in Interventional group patients BEFORE last placebo acupuncture session
Description
Radial diffusivity of the White Matter in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
60 days after the initial inclusion visit (Day 60) - end of therapy
Title
Radial diffusivity of the White Matter in Placebo group patients AFTER last placebo acupuncture session
Description
Radial diffusivity of the White Matter in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
60 days after the initial inclusion visit (Day 60) - end of therapy
Title
Fractional anisotropy of the White Matter in Interventional group patients BEFORE first real acupuncture session
Description
Fractional anisotropy of patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - start of therapy
Title
Fractional anisotropy of the White Matter in Interventional group patients AFTER first real acupuncture session
Description
Fractional anisotropy of patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - start of therapy
Title
Fractional anisotropy of the White Matter in Placebo group patients BEFORE first placebo acupuncture session
Description
Fractional anisotropy in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - start of therapy
Title
Fractional anisotropy of the White Matter in Placebo group patients AFTER first placebo acupuncture session
Description
Fractional anisotropy in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
At the inclusion visit (Vinc) on Day 0 - start of therapy
Title
Fractional anisotropy of the White Matter in Interventional group patients BEFORE last real acupuncture session
Description
Fractional anisotropy in patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
60 days after the initial inclusion visit (Day 60) - end of therapy
Title
Fractional anisotropy of the White Matter in Interventional group patients AFTER last real acupuncture session
Description
Fractional anisotropy in patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
60 days after the initial inclusion visit (Day 60) - end of therapy
Title
Fractional anisotropy of the White Matter in Placebo group patients BEFORE last placebo acupuncture session
Description
Fractional anisotropy in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
60 days after the initial inclusion visit (Day 60) - end of therapy
Title
Fractional anisotropy of the White Matter in Placebo group patients AFTER first placebo acupuncture session
Description
Fractional anisotropy in patients treated with simulated, sham-type acupuncture (Placebo group) is computed with diffusion-weighted magnetic resonance imaging
Time Frame
60 days after the initial inclusion visit (Day 60) - end of therapy
Title
Change in number of days with migraine per month - Interventional group BEFORE treatment
Description
The number of days with migraine per month will be measured according to the days noted on a calendar
Time Frame
At the inclusion visit (Vinc) on Day 0
Title
Change in number of days with migraine per month - Interventional group AFTER treatment
Description
The number of days with migraine per month will be measured according to the days noted on a calendar
Time Frame
At the end of the study (on Day 90)
Title
Change in number of days with migraine per month - Placebo group BEFORE treatment
Description
The number of days with migraine per month will be measured according to the days noted on a calendar
Time Frame
At the inclusion visit (Vinc) on Day 0
Title
Change in number of days with migraine per month - Placebo group AFTER treatment
Description
The number of days with migraine per month will be measured according to the days noted on a calendar
Time Frame
At the end of the study (on Day 90)
Title
Pain BEFORE treatment in the Interventional group
Description
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.
Time Frame
At the inclusion visit (Vinc) on Day 0
Title
Pain AFTER treatment in the Interventional group
Description
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.
Time Frame
At the end of the study (on Day 90)
Title
Pain BEFORE treatment in the Placebo group
Description
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.
Time Frame
At the inclusion visit (Vinc) on Day 0
Title
Pain AFTER treatment in the Placebo group
Description
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.
Time Frame
At the end of the study (on Day 90)
Title
Impact of migraine on the Interventional group patients' Quality of Life (QOL) BEFORE treatment
Description
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.
Time Frame
At the inclusion visit (Vinc) on Day 0
Title
Impact of migraine on the Interventional group patients' Quality of Life (QOL) AFTER treatment
Description
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.
Time Frame
At the end of the study on Day 90
Title
Impact of migraine on the Placebo group patients' Quality of Life (QOL) BEFORE treatment.
Description
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.
Time Frame
At the inclusion visit (Vinc) on Day 0
Title
Impact of migraine on the Placebo group patients' Quality of Life (QOL) AFTER treatment.
Description
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.
Time Frame
At the end of the study on Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc FREARD, Dr.
Phone
06.19.42.18.37
Email
marc.freard@chu-nimes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fabricio PEREIRA, Dr.
Phone
07.85.92.64.02
Email
fabricio.pereira@umontpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anissa MEGZARI, Mme.
Organizational Affiliation
CHU de Nîmes (Nîmes University Hospital)
Official's Role
Study Director
Facility Information:
Facility Name
Marc FREARD
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc FREARD
Phone
0619421837
Email
marc.freard@chu-nimes.fr

12. IPD Sharing Statement

Learn more about this trial

Brain Connectome for Acupuncture-treated Migraine Patients

We'll reach out to this number within 24 hrs