Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Not applicable

Study of the Link Between Structural Alterations in the Hypothalamus and Cardiac Dysautonomia in Drug-resistant Epilepsy

NCT07888543 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-09-10
Last updated
2026-10-22

Condition(s) studied

EpilepsyHypothalamusSeizures- Cardiac DysautonomiaSUDEP

Investigational drug(s) / intervention(s)

MRI scanelectrocardiogram

MRI scan: Patients will be recruited and included by the epileptologist in the clinical neurophysiology department, after verification of the inclusion criteria. The patient will then undergo an MRI scan on the 7T machine at Lille University Hospital during the Amiens shifts. The anonymized images will be transmitted to Amiens-Picardie University Hospital via an existing secure system. The images will be processed in Amiens under the supervision of Prof. Constans.

electrocardiogram: Heart rate variability parameters will be calculated from the patients' electrocardiograms, performed as part of their care under the supervision of Prof. Szurhaj.

Study summary

Patients with drug-resistant epilepsy may have cardiac dysautonomia, with reduced heart rate variability and increased sympathetic tone. This condition is part of the concept of "epileptic heart" and could be a risk factor for sudden death, one of the main causes of excess mortality in patients with severe epilepsy in adulthood. The mechanism of this cardiac impairment is poorly understood. The hypothalamus, due to its role as the subcortical conductor of the autonomic nervous system and its known links with the limbic system, particularly the amygdala and hippocampus, is a candidate for a key intermediary role in the impact of seizures on cardiorespiratory function. The investigators wish to investigate the hypothesis that cardiac dysautonomia in patients with drug-resistant epilepsy is correlated with structural changes in the hypothalamus. The investigators wish to study in 7Tesla MRI the volume of the different hypothalamic nuclei, the amygdalo- hypothalamic and hypothalamo-bulbar connectivity, as well as the metabolic content in spectroscopy in patients with drug-resistant epilepsy, and correlate these data with the sympathetic and parasympathetic tones of these patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients \> 18 years old * With drug-resistant epilepsy * Followed up at Amiens Picardie University Hospital * With at least one seizure recorded by video-EEG (or SEEG) in the 4 years prior to inclusion * Having had a good-quality electroencephalogram with ECG within the last 6 months prior to inclusion * Having given their informed consent, both verbally and in writing. * Covered by Social Security Exclusion Criteria: * Pregnant women * Contraindications to MRI * Claustrophobia, or any other condition that prevents the patient from remaining in the MRI machine for 40 minutes * History of cardiovascular disorders: arrhythmia, conduction disorders, myocardial infarction, high blood pressure. * History of endocrine disorders, precocious puberty, intellectual disability, eating disorders (obesity BMI\>35, anorexia) * Patients with dissociative functional seizures * Patients with epilepsy related to hypothalamic hamartoma or a genetic cause identified in genes coding for ion channels, particularly SCN1A, SCN1B, and CACNa1a

Primary outcome measure(s)

  • Correlation coefficient between the volume of the posterior hypothalamic nucleus with the degree of cardiac autonomic function impairment — 5 months
    Correlation coefficient between the volume of the posterior hypothalamic nucleus with the degree of cardiac autonomic function impairment across the entire cohort of patients with epilepsy

Trial sites (1)

FacilityCityRegionStatus
Amiens University Hospital Amiens Picardie Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07888543 on ClinicalTrials.gov ↗ ← All trials in France