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

Centre Hospitalier Universitaire de Nīmes

Status: Enrolling

Conditions: Migraine Without Aura; Acupuncture Therapy

Treatments: Other: Real acupuncture; Other: Sham acupuncture (placebo group)

Study type: Interventional

Funder types: Other

Identifiers

NCT04157192

RCB : 2019-A00588-49

Details and patient eligibility

About

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 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Patients receiving real acupuncture treatment

Active Comparator group

Description:

Treatment with needle insertion

Treatment:

Other: Real acupuncture

Patients receiving sham acupuncture treatment

Sham Comparator group

Description:

Treatment without needle insertion

Treatment:

Other: Sham acupuncture (placebo group)