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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Migraine
• Intervention / Treatment: Behavioral: Cognitive assessment mapping

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric SALVAT, MD; Phone Number: 0033 03 88 12 51 18; Email: eric.salvat@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Hôpitaux Universitaires de Strasbourg
    • Contact: Eric SALVAT, MD; Phone Number: 0033 03 88 12 51 18; Email: eric.salvat@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: migraine	Behavioral: Cognitive assessment mapping; Test E-Miles - MoCA - MMSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
E-MILE cognitive profile mapping	Month12

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RC26_0200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No