Migraine Without Aura Clinical Trial
— ACU-BRAINOfficial 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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | October 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Marc FREARD | Nîmes |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | At the inclusion visit (Vinc) on Day 0 - start of therapy | |
Secondary | 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 | At the inclusion visit (Vinc) on Day 0 - start of therapy | |
Secondary | 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 | At the inclusion visit (Vinc) on Day 0 - start of therapy | |
Secondary | 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 | At the inclusion visit (Vinc) on Day 0 - start of therapy | |
Secondary | 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 | 60 days after the initial inclusion visit (Day 60) - end of therapy | |
Secondary | 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 | 60 days after the initial inclusion visit (Day 60) - end of therapy | |
Secondary | 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 | 60 days after the initial inclusion visit (Day 60) - end of therapy | |
Secondary | 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 | 60 days after the initial inclusion visit (Day 60) - end of therapy | |
Secondary | 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 | At the inclusion visit (Vinc) on Day 0 - start of therapy | |
Secondary | 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 | At the inclusion visit (Vinc) on Day 0 - start of therapy | |
Secondary | 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 | At the inclusion visit (Vinc) on Day 0 - start of therapy | |
Secondary | 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 | At the inclusion visit (Vinc) on Day 0 - start of therapy | |
Secondary | 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 | 60 days after the initial inclusion visit (Day 60) - end of therapy | |
Secondary | 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 | 60 days after the initial inclusion visit (Day 60) - end of therapy | |
Secondary | 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 | 60 days after the initial inclusion visit (Day 60) - end of therapy | |
Secondary | 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 | 60 days after the initial inclusion visit (Day 60) - end of therapy | |
Secondary | 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 | At the inclusion visit (Vinc) on Day 0 - start of therapy | |
Secondary | 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 | At the inclusion visit (Vinc) on Day 0 - start of therapy | |
Secondary | 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 | At the inclusion visit (Vinc) on Day 0 - start of therapy | |
Secondary | 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 | At the inclusion visit (Vinc) on Day 0 - start of therapy | |
Secondary | 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 | 60 days after the initial inclusion visit (Day 60) - end of therapy | |
Secondary | 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 | 60 days after the initial inclusion visit (Day 60) - end of therapy | |
Secondary | 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 | 60 days after the initial inclusion visit (Day 60) - end of therapy | |
Secondary | 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 | 60 days after the initial inclusion visit (Day 60) - end of therapy | |
Secondary | 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 | At the inclusion visit (Vinc) on Day 0 | |
Secondary | 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 | At the end of the study (on Day 90) | |
Secondary | 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 | At the inclusion visit (Vinc) on Day 0 | |
Secondary | 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 | At the end of the study (on Day 90) | |
Secondary | 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. | At the inclusion visit (Vinc) on Day 0 | |
Secondary | 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. | At the end of the study (on Day 90) | |
Secondary | 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. | At the inclusion visit (Vinc) on Day 0 | |
Secondary | 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. | At the end of the study (on Day 90) | |
Secondary | 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. | At the inclusion visit (Vinc) on Day 0 | |
Secondary | 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. | At the end of the study on Day 90 | |
Secondary | 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. | At the inclusion visit (Vinc) on Day 0 | |
Secondary | 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. | At the end of the study on Day 90 |
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