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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01985-42 | Other Identifier | ANSM |
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This is a prospective clinical study evaluating the analgesic efficacy of a non-medicated treatment: repeated transcranial magnetic stimulation (rTMS) of the primary motor cortex in chronic migraine (> 7 headache days per month and failure of at least 3 drug treatments).
To this end, the study involves a double-blind, randomized, comparative experimental protocol against a sham control condition via 2 parallel groups comprising 60 patients each (N= 120 in total). Randomized block design with stratification by center and type of migraine (episodic or chronic).
5 rTMS sessions will be performed, with one stimulation session every 2 weeks. One group will receive active stimulation at each session (high-frequency stimulation of the left primary motor cortex, 2000 pulses per session, 80% of resting motor threshold) and the other group placebo stimulation (sham).
Depending on the randomization group, rTMS sessions will be carried out by trained experimenters in the investigating center where the patient has been included. The study is multicentric, with five centers, four of which are in the Auvergne-Rhône-Alpes region. Data will be centralized at the Clermont-Ferrand University Hospital, and statistical analysis will be carried out by the Clermont-Ferrand University Hospital's Clinical Research and Innovation Department. Principal difference analysis (active vs sham) performed in ITT; missing data processed by multiple imputation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS stimulation | Experimental |
| |
| sham rTMS stimulation | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive Transcranial Magnetic Stimulation (rTMS) | Device | robot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variation of headaches days number per month | difference between the 4 weeks prior to initiation of treatment and the last 4 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| variation in the number of headache (days per month) of at least 50% | between the 4 weeks prior to initiation of treatment and the last 4 weeks post-treatment | |
| variation in the number of headache (days per month) of at least 30%. | between the 4 weeks prior to initiation of treatment and the last 4 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Bang blinding index | The patient will be asked what he thinks he received after the treatment, rTMS neuromodulation or sham neuromodulation | week 0, week 2, week 4, week 6, week 8, week 12 |
| Variation of blood cytokine levels |
Inclusion criteria :
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise LACLAUTRE | Contact | 04.73.75.49.63 | promo_interne_drci@chu-clermontferrand.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | France | France |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| sham repetitive Magnetic Transcranial Stimulation (rTMS) | Device | sham robot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex |
|
| Patient Global Impression of Change (PGIC) | The score varies from 1 to 7 . A score of 1 means a better outcome and a score of 7 means a worse outcome | at week 12 |
Following cytokines levels will be assessed : IL-6, IL-10, IL-17, IL-18, IL-1α, IL-1β, IL-21, IL-22, IL-23, IL-33, IL-35, CCL-20, IL-36β, IL-37, IL-38, IL-1Ra, TNFa, TGFβ, IL-2, INF-γ
| Before (Week 0) and after treatment (Weeks 8 and 12) |
| Variation of headaches days number per month | Every each 4-week period post-treatment, compared to 4 weeks before treatment initiation |
| Migraine Hypersensitivity Assessment Questionnaire (MHQ-8 scale, ex-MIGAL) score | This scale assesses the frequency and intensity of disturbances related to noise, light, skin stimulation, and odors during migraines | Pre-treatment period (inclusion visit at W0 - 4) and at week 12 |
| Improvement in Quality of life by migraine rescue medication intakes | Improvement in quality of life will be assessed by use of migraine rescue medication before and after neurostimulation | Week0 - 4 to week0 -1 period compared to Week 9 - week 12 period |
| Improvement in Quality of life by European Quality of Life 5 dimensions (EQ- 5D) scale score | Improvement in quality of life will be assessed by the change of EQ-5D score | At week 0, week 8 and week 12 |
| Improvement in Quality of life by relief subjective rate | A relief subjective rate since last neurostimulation will be asked to patient before each new neurostimulation session . A rate of 0% means "no relief" and 100% means a complete relief . | At Week 2, week 4, week 6, week 8 and week 12 |
| Improvement in Quality of life by anxiety and depression scores | Anxiety and depression will be assessed by Hospital Anxiety and Depression Scale (HADS) | At screening visit (Week 0 - 4) and week 12 |
| Improvement in Quality of life by resilience score | Resilience score will be assessed by Connor-Davidson Resilience Scale (CD-RISC) in 25 items. The score ranges from 0 to 100 and a higher score means a higher resilience | At screening visit (Week 0-4) and week 12 |
| Improvement in Quality of life by catastrophizing score | Catastrophism will be assessed by Pain Catastrophizing Scale (PCS) . Score ranges from 0 to 52. A higher score indicates a higher level of catastrophizing of pain. | At screening visit (Week 0-4) and week 12 |
| Improvement in Quality of life by intensity and emotional experience of pain | A visual analogue scale (VAS) ranging from 0 to 100 for pain intensity and affective experience will be used. | At screening visit (week 0- 4) and week 12 |
| Brain activity (resting-state fMRI) | MRI recording is routinely carried out before any rTMS session. This involves acquiring a 3D image of the participants' brains, which is necessary for targeting cortical area stimulated by rTMS using a neuronavigation system. Functional imaging (fMRI) in a resting state (i.e., without a 'resting-state' task) will allow to measure the basal state of activity and connectivity in the participants' brains. | At screening visit (week 0- 4) and week 12 |
| Cortical excitability | measured during rTMS motor threshold with paired pulse stimulation measurements | At week 0 and week 12 |
| Evaluation of side effects | up to 4 weeks post-treatment (at week 12) |
| Changes in prognostic markers of response | Following blood parameters will be assessed : Blood count, CRP, Venous glycemia, Insulin, prolactin, estradiol, FSH, LH, progesterone, testosterone, β-hCG, CGRP, VIP, PACAP-38, IL-6, IL-10, IL-17, IL-18, IL-1α, IL-1β, IL-21, IL-22, IL-23, IL-33, IL-35, CCL-20, IL-36β, IL-37, IL-38, IL-1Ra, TNFa, TGFβ, IL-2, INF-γ, T lymphocyte immunophenotyping (CD3, CD4, CD25, FoxP3, CTLA-4, ICOS, TNFR2, CD45, CD45RA, CD8, CD14, 4-1-BB, NKp46, CD19, CD197, CD39, CD73, GITR, TCRaβ, CD127, CD56, CD62L) | At week 0, week 8 and week 12 |
| Patient Global Impression of Change (PGIC) | The score ranges from 1 to 7. A score of 1 means a better outcome and a score of 7 means a worse outcome | week 2, week 4, week 6, week 8 |
| D009422 | Nervous System Diseases |