Brain Connectome for Acupuncture-treated Migraine Patients

NCT04157192 | Unknown

• 1 other identifier: RCB : 2019-A00588-49
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Without Aura; Acupuncture Therapy

Keywords

Acupuncture

Outcome Measures

Primary Outcomes (8)

• 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

  At the inclusion visit (Vinc) on Day 0 - Start of therapy

• 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

  At the inclusion visit (Vinc) on Day 0 - Start of therapy

• 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

  At the inclusion visit (Vinc) on Day 0 - Start of therapy

• 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

  At the inclusion visit (Vinc) on Day 0 - Start of therapy

• 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

  Sixty days after inclusion in the trial (Day 60) - end of therapy

• 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

  Sixty days after inclusion in the trial (Day 60) - end of therapy

• 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

  Sixty days after inclusion in the trial (Day 60) - end of therapy

• 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

  Sixty days after inclusion in the trial (Day 60) - end of therapy

Secondary Outcomes (36)

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

  At the inclusion visit (Vinc) on Day 0 - start of therapy

• Mean diffusivity of White Matter of Interventional group patients AFTER first real acupuncture session

  At the inclusion visit (Vinc) on Day 0 - start of therapy

• Mean diffusivity of White Matter of Placebo group patients BEFORE first placebo acupuncture session

  At the inclusion visit (Vinc) on Day 0 - start of therapy

• Mean diffusivity of White Matter of Placebo group patients AFTER first placebo acupuncture session

  At the inclusion visit (Vinc) on Day 0 - start of therapy

• Mean diffusivity of White Matter of Interventional group patients BEFORE last real acupuncture session

  60 days after the initial inclusion visit (Day 60) - end of therapy

Study Arms (2)

Patients receiving real acupuncture treatment

ACTIVE COMPARATOR

Treatment with needle insertion

Other: Real acupuncture

Patients receiving sham acupuncture treatment

SHAM COMPARATOR

Treatment without needle insertion

Other: Sham acupuncture (placebo group)

Interventions

Real acupuncture OTHER

The patient will be treated for migraine with real acupuncture.

Patients receiving real acupuncture treatment

Sham acupuncture (placebo group) OTHER

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.

Patients receiving sham acupuncture treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Marc FREARD

Nîmes, France

RECRUITING

MeSH Terms

Conditions

Migraine without Aura

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Anissa MEGZARI, Mme.

  CHU de Nîmes (Nîmes University Hospital)

  STUDY DIRECTOR

Central Study Contacts

Marc FREARD, Dr.

CONTACT

06.19.42.18.37; marc.freard@chu-nimes.fr

Fabricio PEREIRA, Dr.

CONTACT

07.85.92.64.02; fabricio.pereira@umontpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: May 27, 2022
• Primary Completion: May 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

FR (1)