Evolution of the Cognitive Profile and Quality of Life of Adult Patients Suffering From Severe Migraines Under Preventive Treatment

NCT07691164 | Not Yet Recruiting

• 1 other identifier: RC26_0200
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• E-MILE cognitive profile mapping

  Month12

Study Arms (1)

migraine

EXPERIMENTAL

Behavioral: Cognitive assessment mapping

Interventions

Cognitive assessment mapping BEHAVIORAL

Test E-Miles - MoCA - MMSE

migraine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Central Study Contacts

Eric SALVAT, MD

CONTACT

03 88 12 51 18; eric.salvat@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 8, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)