Clinical trial NCT04157192: Brain Connectome for Acupuncture-treated Migraine Patients
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
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine Without Aura
Acupuncture Therapy
Keywords: Acupuncture
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Regional homogeneity map in Interventional group patients BEFORE first real acupuncture session.
timeFrame: At the inclusion visit (Vinc) on Day 0 - Start of therapy
measure: Regional homogeneity map in Interventional group patients AFTER first real acupuncture session.
timeFrame: At the inclusion visit (Vinc) on Day 0 - Start of therapy
measure: Regional homogeneity map in Placebo group patients BEFORE first real acupuncture session.
timeFrame: At the inclusion visit (Vinc) on Day 0 - Start of therapy
measure: Regional homogeneity map in Placebo group patients AFTER first real acupuncture session.
timeFrame: At the inclusion visit (Vinc) on Day 0 - Start of therapy
measure: Regional homogeneity map in Interventional group patients BEFORE last real acupuncure session
timeFrame: Sixty days after inclusion in the trial (Day 60) - end of therapy
measure: Regional homogeneity map in Interventional group patients AFTER last real acupuncure session
timeFrame: Sixty days after inclusion in the trial (Day 60) - end of therapy
measure: Regional homogeneity map of Placebo group patients BEFORE last placebo acupuncture session
timeFrame: Sixty days after inclusion in the trial (Day 60) - end of therapy
measure: Regional homogeneity map of Placebo group patients AFTER last placebo acupuncture session
timeFrame: Sixty days after inclusion in the trial (Day 60) - end of therapy
Secondary outcomes:
measure: Mean diffusivity of White Matter of Interventional group patients BEFORE first real acupuncture session
timeFrame: At the inclusion visit (Vinc) on Day 0 - start of therapy
measure: Mean diffusivity of White Matter of Interventional group patients AFTER first real acupuncture session
timeFrame: At the inclusion visit (Vinc) on Day 0 - start of therapy
measure: Mean diffusivity of White Matter of Placebo group patients BEFORE first placebo acupuncture session
timeFrame: At the inclusion visit (Vinc) on Day 0 - start of therapy
measure: Mean diffusivity of White Matter of Placebo group patients AFTER first placebo acupuncture session
timeFrame: At the inclusion visit (Vinc) on Day 0 - start of therapy
measure: Mean diffusivity of White Matter of Interventional group patients BEFORE last real acupuncture session
timeFrame: 60 days after the initial inclusion visit (Day 60) - end of therapy
measure: Mean diffusivity of White Matter of Interventional group patients AFTER last real acupuncture session
timeFrame: 60 days after the initial inclusion visit (Day 60) - end of therapy
measure: Mean diffusivity of White Matter of Placebo group patients BEFORE last placebo acupuncture session
timeFrame: 60 days after the initial inclusion visit (Day 60) - end of therapy
measure: Mean diffusivity of White Matter of Placebo group patients AFTER last placebo acupuncture session
timeFrame: 60 days after the initial inclusion visit (Day 60) - end of therapy
measure: Radial diffusivity of the White Matter in Interventional group patients BEFORE first real acupuncture session
timeFrame: At the inclusion visit (Vinc) on Day 0 - start of therapy
measure: Radial diffusivity of the White Matter in Interventional group patients AFTER first real acupuncture session
timeFrame: At the inclusion visit (Vinc) on Day 0 - start of therapy
measure: Radial diffusivity of the White Matter in Placebo group patients BEFORE first placebo acupuncture session
timeFrame: At the inclusion visit (Vinc) on Day 0 - start of therapy
measure: Radial diffusivity of the White Matter in Placebo group patients AFTER first placebo acupuncture session
timeFrame: At the inclusion visit (Vinc) on Day 0 - start of therapy
measure: Radial diffusivity of the White Matter in Interventional group patients BEFORE last real acupuncture session
timeFrame: 60 days after the initial inclusion visit (Day 60) - end of therapy
measure: Radial diffusivity of the White Matter in Placebo group patients AFTER last real acupuncture session
timeFrame: 60 days after the initial inclusion visit (Day 60) - end of therapy
measure: Radial diffusivity of the White Matter in Interventional group patients BEFORE last placebo acupuncture session
timeFrame: 60 days after the initial inclusion visit (Day 60) - end of therapy
measure: Radial diffusivity of the White Matter in Placebo group patients AFTER last placebo acupuncture session
timeFrame: 60 days after the initial inclusion visit (Day 60) - end of therapy
measure: Fractional anisotropy of the White Matter in Interventional group patients BEFORE first real acupuncture session
timeFrame: At the inclusion visit (Vinc) on Day 0 - start of therapy
measure: Fractional anisotropy of the White Matter in Interventional group patients AFTER first real acupuncture session
timeFrame: At the inclusion visit (Vinc) on Day 0 - start of therapy
measure: Fractional anisotropy of the White Matter in Placebo group patients BEFORE first placebo acupuncture session
timeFrame: At the inclusion visit (Vinc) on Day 0 - start of therapy
measure: Fractional anisotropy of the White Matter in Placebo group patients AFTER first placebo acupuncture session
timeFrame: At the inclusion visit (Vinc) on Day 0 - start of therapy
measure: Fractional anisotropy of the White Matter in Interventional group patients BEFORE last real acupuncture session
timeFrame: 60 days after the initial inclusion visit (Day 60) - end of therapy
measure: Fractional anisotropy of the White Matter in Interventional group patients AFTER last real acupuncture session
timeFrame: 60 days after the initial inclusion visit (Day 60) - end of therapy
measure: Fractional anisotropy of the White Matter in Placebo group patients BEFORE last placebo acupuncture session
timeFrame: 60 days after the initial inclusion visit (Day 60) - end of therapy
measure: Fractional anisotropy of the White Matter in Placebo group patients AFTER first placebo acupuncture session
timeFrame: 60 days after the initial inclusion visit (Day 60) - end of therapy
measure: Change in number of days with migraine per month - Interventional group BEFORE treatment
timeFrame: At the inclusion visit (Vinc) on Day 0
measure: Change in number of days with migraine per month - Interventional group AFTER treatment
timeFrame: At the end of the study (on Day 90)
measure: Change in number of days with migraine per month - Placebo group BEFORE treatment
timeFrame: At the inclusion visit (Vinc) on Day 0
measure: Change in number of days with migraine per month - Placebo group AFTER treatment
timeFrame: At the end of the study (on Day 90)
measure: Pain BEFORE treatment in the Interventional group
timeFrame: At the inclusion visit (Vinc) on Day 0
measure: Pain AFTER treatment in the Interventional group
timeFrame: At the end of the study (on Day 90)
measure: Pain BEFORE treatment in the Placebo group
timeFrame: At the inclusion visit (Vinc) on Day 0
measure: Pain AFTER treatment in the Placebo group
timeFrame: At the end of the study (on Day 90)
measure: Impact of migraine on the Interventional group patients' Quality of Life (QOL) BEFORE treatment
timeFrame: At the inclusion visit (Vinc) on Day 0
measure: Impact of migraine on the Interventional group patients' Quality of Life (QOL) AFTER treatment
timeFrame: At the end of the study on Day 90
measure: Impact of migraine on the Placebo group patients' Quality of Life (QOL) BEFORE treatment.
timeFrame: At the inclusion visit (Vinc) on Day 0
measure: Impact of migraine on the Placebo group patients' Quality of Life (QOL) AFTER treatment.
timeFrame: At the end of the study on Day 90
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Marc FREARD
Study officials:
affiliation: CHU de Nîmes (Nîmes University Hospital)
name: Anissa MEGZARI, Mme.
role: STUDY_DIRECTOR
References: