Migraine Without AuraACU-BRAINNCT04157192
Brain Connectome for Acupuncture-treated Migraine Patients
A study testing Real acupuncture in people with Migraine Without Aura and Acupuncture Therapy, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Without Aura, Acupuncture Therapy
- What is being tested?
- Real acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2022to 24 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Migraine Without Aura, Acupuncture Therapy
- Being tested
- Real acupuncture, Sham acupuncture (placebo group)
- Keywords
- Acupuncture
- Medical subject headings
- Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real acupunctureOther
The patient will be treated for migraine with real acupuncture.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving real acupuncture treatment | Active comparator | Treatment with needle insertion Receives: Other: Real acupuncture |
| Patients receiving sham acupuncture treatment | Sham comparator | Treatment without needle insertion Receives: Other: Sham acupuncture (placebo group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
The mean diffusivity of White Matter of Interventional group patients is computed with diffusion-weighted magnetic resonance imaging
Measured: 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
The mean diffusivity of White Matter of Interventional group patients is computed with diffusion-weighted magnetic resonance imaging
Measured: 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
The mean diffusivity of White Matter of Placebo group patients is computed with diffusion-weighted magnetic resonance imaging
Measured: 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
The mean diffusivity of White Matter of Placebo group patients is computed with diffusion-weighted magnetic resonance imaging
Measured: 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
The mean diffusivity of White Matter in patients treated with real acupuncture (Interventional group) is computed with diffusion-weighted magnetic resonance imaging
Measured: 60 days after the initial inclusion visit (Day 60) - end of therapy
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
Measured: 60 days after the initial inclusion visit (Day 60) - end of therapy
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
Measured: 60 days after the initial inclusion visit (Day 60) - end of therapy
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
Measured: 60 days after the initial inclusion visit (Day 60) - end of therapy
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
Measured: At the inclusion visit (Vinc) on Day 0 - start of therapy
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
Measured: At the inclusion visit (Vinc) on Day 0 - start of therapy
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
Measured: At the inclusion visit (Vinc) on Day 0 - start of therapy
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
Measured: At the inclusion visit (Vinc) on Day 0 - start of therapy
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
Measured: 60 days after the initial inclusion visit (Day 60) - end of therapy
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
Measured: 60 days after the initial inclusion visit (Day 60) - end of therapy
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
Measured: 60 days after the initial inclusion visit (Day 60) - end of therapy
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
Measured: 60 days after the initial inclusion visit (Day 60) - end of therapy
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
Measured: At the inclusion visit (Vinc) on Day 0 - start of therapy
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
Measured: At the inclusion visit (Vinc) on Day 0 - start of therapy
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
Measured: At the inclusion visit (Vinc) on Day 0 - start of therapy
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
Measured: At the inclusion visit (Vinc) on Day 0 - start of therapy
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
Measured: 60 days after the initial inclusion visit (Day 60) - end of therapy
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
Measured: 60 days after the initial inclusion visit (Day 60) - end of therapy
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
Measured: 60 days after the initial inclusion visit (Day 60) - end of therapy
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
Measured: 60 days after the initial inclusion visit (Day 60) - end of therapy
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
Measured: At the inclusion visit (Vinc) on Day 0
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
Measured: At the end of the study (on Day 90)
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
Measured: At the inclusion visit (Vinc) on Day 0
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
Measured: At the end of the study (on Day 90)
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.
Measured: At the inclusion visit (Vinc) on Day 0
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.
Measured: At the end of the study (on Day 90)
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.
Measured: At the inclusion visit (Vinc) on Day 0
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.
Measured: At the end of the study (on Day 90)
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.
Measured: At the inclusion visit (Vinc) on Day 0
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.
Measured: At the end of the study on Day 90
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.
Measured: At the inclusion visit (Vinc) on Day 0
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.
Measured: At the end of the study on Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start27 May 2022
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine Without AuraStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Mme., Study director, CHU de Nîmes (Nîmes University Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157192
- Sponsor's protocol ID
- RCB : 2019-A00588-49
- Acronym
- ACU-BRAIN
- Status last verified
- Jun 2026
- First submitted
- 6 Nov 2019
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04157192
- Acronym / sponsor ID
- ACU-BRAIN / RCB : 2019-A00588-49
- Conditions
- Migraine Without Aura, Acupuncture Therapy
- Keywords
- Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 27 May 2022 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients receiving real acupuncture treatment | Active comparator | Other: Real acupunctureTreatment with needle insertion |
| Patients receiving sham acupuncture treatment | Sham comparator | Other: Sham acupuncture (placebo group)Treatment without needle insertion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real acupunctureThe patient will be treated for migraine with real acupuncture. | Other | Patients receiving real acupuncture treatment |
| 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. | Other | Patients receiving sham acupuncture treatment |
Primary outcome
Regional homogeneity map in Interventional group patients BEFORE first real acupuncture session.
Time frame: At the inclusion visit (Vinc) on Day 0 - Start of therapy
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.
Time frame: At the inclusion visit (Vinc) on Day 0 - Start of therapy
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.
Time frame: At the inclusion visit (Vinc) on Day 0 - Start of therapy
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.
Time frame: At the inclusion visit (Vinc) on Day 0 - Start of therapy
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
Time frame: Sixty days after inclusion in the trial (Day 60) - end of therapy
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
Time frame: Sixty days after inclusion in the trial (Day 60) - end of therapy
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
Time frame: Sixty days after inclusion in the trial (Day 60) - end of therapy
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
Time frame: Sixty days after inclusion in the trial (Day 60) - end of therapy
Regional homogeneity in patients treated via simulated, sham-type acupuncture (Placebo group) is computed with functional magnetic resonance imaging
36 secondary outcomes
Mean diffusivity of White Matter of Interventional group patients BEFORE first real acupuncture session
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 60 days after the initial inclusion visit (Day 60) - end of therapy
Mean diffusivity of White Matter of Interventional group patients AFTER last real acupuncture session
Time frame: 60 days after the initial inclusion visit (Day 60) - end of therapy
Mean diffusivity of White Matter of Placebo group patients BEFORE last placebo acupuncture session
Time frame: 60 days after the initial inclusion visit (Day 60) - end of therapy
Mean diffusivity of White Matter of Placebo group patients AFTER last placebo acupuncture session
Time frame: 60 days after the initial inclusion visit (Day 60) - end of therapy
Radial diffusivity of the White Matter in Interventional group patients BEFORE first real acupuncture session
Time frame: At the inclusion visit (Vinc) on Day 0 - start of therapy
Radial diffusivity of the White Matter in Interventional group patients AFTER first real acupuncture session
Time frame: At the inclusion visit (Vinc) on Day 0 - start of therapy
Radial diffusivity of the White Matter in Placebo group patients BEFORE first placebo acupuncture session
Time frame: At the inclusion visit (Vinc) on Day 0 - start of therapy
Radial diffusivity of the White Matter in Placebo group patients AFTER first placebo acupuncture session
Time frame: At the inclusion visit (Vinc) on Day 0 - start of therapy
Radial diffusivity of the White Matter in Interventional group patients BEFORE last real acupuncture session
Time frame: 60 days after the initial inclusion visit (Day 60) - end of therapy
Radial diffusivity of the White Matter in Placebo group patients AFTER last real acupuncture session
Time frame: 60 days after the initial inclusion visit (Day 60) - end of therapy
Radial diffusivity of the White Matter in Interventional group patients BEFORE last placebo acupuncture session
Time frame: 60 days after the initial inclusion visit (Day 60) - end of therapy
Radial diffusivity of the White Matter in Placebo group patients AFTER last placebo acupuncture session
Time frame: 60 days after the initial inclusion visit (Day 60) - end of therapy
Fractional anisotropy of the White Matter in Interventional group patients BEFORE first real acupuncture session
Time frame: At the inclusion visit (Vinc) on Day 0 - start of therapy
Fractional anisotropy of the White Matter in Interventional group patients AFTER first real acupuncture session
Time frame: At the inclusion visit (Vinc) on Day 0 - start of therapy
Fractional anisotropy of the White Matter in Placebo group patients BEFORE first placebo acupuncture session
Time frame: At the inclusion visit (Vinc) on Day 0 - start of therapy
Fractional anisotropy of the White Matter in Placebo group patients AFTER first placebo acupuncture session
Time frame: At the inclusion visit (Vinc) on Day 0 - start of therapy
Fractional anisotropy of the White Matter in Interventional group patients BEFORE last real acupuncture session
Time frame: 60 days after the initial inclusion visit (Day 60) - end of therapy
Fractional anisotropy of the White Matter in Interventional group patients AFTER last real acupuncture session
Time frame: 60 days after the initial inclusion visit (Day 60) - end of therapy
Fractional anisotropy of the White Matter in Placebo group patients BEFORE last placebo acupuncture session
Time frame: 60 days after the initial inclusion visit (Day 60) - end of therapy
Fractional anisotropy of the White Matter in Placebo group patients AFTER first placebo acupuncture session
Time frame: 60 days after the initial inclusion visit (Day 60) - end of therapy
Change in number of days with migraine per month - Interventional group BEFORE treatment
Time frame: At the inclusion visit (Vinc) on Day 0
Change in number of days with migraine per month - Interventional group AFTER treatment
Time frame: At the end of the study (on Day 90)
Change in number of days with migraine per month - Placebo group BEFORE treatment
Time frame: At the inclusion visit (Vinc) on Day 0
Change in number of days with migraine per month - Placebo group AFTER treatment
Time frame: At the end of the study (on Day 90)
Pain BEFORE treatment in the Interventional group
Time frame: At the inclusion visit (Vinc) on Day 0
Pain AFTER treatment in the Interventional group
Time frame: At the end of the study (on Day 90)
Pain BEFORE treatment in the Placebo group
Time frame: At the inclusion visit (Vinc) on Day 0
Pain AFTER treatment in the Placebo group
Time frame: At the end of the study (on Day 90)
Impact of migraine on the Interventional group patients' Quality of Life (QOL) BEFORE treatment
Time frame: At the inclusion visit (Vinc) on Day 0
Impact of migraine on the Interventional group patients' Quality of Life (QOL) AFTER treatment
Time frame: At the end of the study on Day 90
Impact of migraine on the Placebo group patients' Quality of Life (QOL) BEFORE treatment.
Time frame: At the inclusion visit (Vinc) on Day 0
Impact of migraine on the Placebo group patients' Quality of Life (QOL) AFTER treatment.
Time frame: At the end of the study on Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anissa MEGZARI, Mme. study director
CHU de Nîmes (Nîmes University Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real acupuncture in people with Migraine Without Aura and Acupuncture Therapy, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional homogeneity map in Interventional group patients BEFORE first real acupuncture session. (time frame: At the inclusion visit (Vinc) on Day 0 - Start of therapy). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.