Evolution of the Cognitive Profile and Quality of Life of Adult Patients Suffering From Severe Migraines Under Preventive Treatment (CEREB)
In chronic migraine, we routinely use innovative treatments such as peri-cranial injections of botulinum toxin type A according to the PREEMPT protocol, or intravenous Eptinezumab, both targeting the Calcitonin Gene-Related Peptide (CGRP). We observe significant improvement in 70-80% of our patients after one year of treatment, corresponding to at least a 30-50% reduction in the number of migraines per month, together with improvements in anxiety and depression comorbidities (HADS), catastrophizing scores (PCS), and the impact of migraines on quality of life (HIT-6).
Our main hypothesis, based on our clinical experience and the literature, is that the cognitive profile of these adult patients-particularly attention and memory, as assessed by a validated self-report questionnaire-improves following treatment with botulinum toxin type A administered according to the PREEMPT protocol or intravenous anti-CGRP antibody infusions (Eptinezumab), alongside improvement in migraine disease activity (number of migraines per month), after one year of treatment.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Eric SALVAT, MD
- Telefonnummer: 0033 03 88 12 51 18
- E-post: eric.salvat@chru-strasbourg.fr
Studieorter
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Strasbourg, Frankrike, 67091
- Hopitaux Universitaires de Strasbourg
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Kontakt:
- Eric SALVAT, MD
- Telefonnummer: 0033 03 88 12 51 18
- E-post: eric.salvat@chru-strasbourg.fr
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
Adult patient (legal age) Adult patient suffering from severe treatment-resistant migraine, according to the ICHD-3 criteria, i.e. more than 8 migraine days per month (high-frequency episodic migraine and chronic migraine) Headache condition indicating treatment with botulinum toxin type A according to the PREEMPT protocol or infusion of anti-CGRP antibodies (Eptinezumab) Subject affiliated with a social health insurance scheme Subject able to understand the objectives and risks related to the research and able to provide informed, dated, and signed consent
Exclusion Criteria:
Patient suffering from a central neurological disorder or sequelae (multiple sclerosis, traumatic brain injury with loss of consciousness, stroke, dementia, etc.) Patient suffering from another chronic pain condition (fibromyalgia, low back pain, etc.) Patient suffering from a psychiatric disorder other than anxiety-depressive syndrome Patient suffering from severe disabling auditory or visual impairment, such as profound hearing loss not correctable with hearing aids or blindness
Contraindication to the treatment prescribed as part of routine care:
Botulinum toxin type A: pregnancy, allergic hypersensitivity, myasthenia gravis, Lambert-Eaton syndrome, infection at the injection site Eptinezumab: pregnancy, allergic hypersensitivity, severe cardiovascular disease (stroke, transient ischemic attack, myocardial infarction, coronary artery bypass surgery) Patient currently in an exclusion period (determined by a previous or ongoing study) Inability to provide the subject with informed information (emergency situation, comprehension difficulties, etc.) Subject under judicial protection Subject under guardianship or curatorship Pregnant or breastfeeding woman
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Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: migraine
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Test E-Miles - MoCA - MMSE
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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E-MILE cognitive profile mapping
Tidsram: Month12
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Month12
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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- RC26_0200
Plan för individuella deltagardata (IPD)
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