Brain Connectome for Acupuncture-treated Migraine Patients
NCT ID: NCT04157192
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-05-27
2024-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The imager is also unaware of whether the patient has had sham or real acupuncture.
Study Groups
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Patients receiving real acupuncture treatment
Treatment with needle insertion
Real acupuncture
The patient will be treated for migraine with real acupuncture.
Patients receiving sham acupuncture treatment
Treatment without needle insertion
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.
Interventions
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Real acupuncture
The patient will be treated for migraine with real acupuncture.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
60 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Anissa MEGZARI, Mme.
Role: STUDY_DIRECTOR
CHU de Nîmes (Nîmes University Hospital)
Locations
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Marc FREARD
Nîmes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RCB : 2019-A00588-49
Identifier Type: -
Identifier Source: org_study_id
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