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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Eric SALVAT, MD
- Telefonnummer: 0033 03 88 12 51 18
- E-mail: eric.salvat@chru-strasbourg.fr
Studiesteder
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Strasbourg, Frankrig, 67091
- Hopitaux Universitaires de Strasbourg
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Kontakt:
- Eric SALVAT, MD
- Telefonnummer: 0033 03 88 12 51 18
- E-mail: eric.salvat@chru-strasbourg.fr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: migraine
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Test E-Miles - MoCA - MMSE
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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E-MILE cognitive profile mapping
Tidsramme: Month12
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Month12
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- RC26_0200
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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