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RecruitingNCT07888543HYPOLEPSIEUpdated Oct 22, 2026

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

An interventional study of MRI scan and electrocardiogram in Epilepsy, Hypothalamus and Seizures- Cardiac Dysautonomia, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Epilepsy
  • Hypothalamus
  • Seizures- Cardiac Dysautonomia
  • SUDEP

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Keywords

  • Epilepsy
  • Hypothalamus
  • Seizures- Cardiac dysautonomia
  • SUDEP
03

In context

Epilepsy

1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 1,228 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 582 studies on the registry; 181 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Interventions

  • OtherMRI 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.

  • Otherelectrocardiogram

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

06

What researchers measure

Primary outcomes

  1. Correlation coefficient between the volume of the posterior hypothalamic nucleus with the degree of cardiac autonomic function impairment

    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

    Time frame: 5 months

Secondary outcomes

  1. correlation of anterior nucleus volumes with HRV parameters

    correlation of anterior nucleus volumes with HRV parameters. HRV is heart rate variability. HRV, which is calculated from the intervals between normal heart beats

    Time frame: 5 months

  2. correlation of lateral nucleus volumes with HRV parameters

    correlation of lateral nucleus volumes with HRV parameters HRV is heart rate variability. HRV, which is calculated from the intervals between normal heart beats

    Time frame: 5 months

  3. correlation of the posterior nucleus volumes with the risk of SUDEP

    correlation of the posterior nucleus volumes with the risk of SUDEP

    Time frame: 5 months

  4. correlation of the lateral nucleus volumes with the risk of SUDEP

    correlation of the lateral nucleus volumes with the risk of SUDEP

    Time frame: 5 months

  5. correlation of the anterior nucleus volumes with the risk of SUDEP

    correlation of the anterior nucleus volumes with the risk of SUDEP

    Time frame: 5 months

  6. correlation of structural connectivity values with heart rate variability parameters

    Correlation of the structural connectivity values (amygdalo-hypothalamic tract, hypothalamo-bulbar tract, and intra-hypothalamic connectivity) with heart rate variability parameters. HRV is heart rate variability. HRV, which is calculated from the intervals between normal heart beats

    Time frame: 5 months

  7. Correlation of metabolic values of the hypothalamus and the bulbar region with heart rate variability parameters

    Correlation of metabolic values of the hypothalamus and the bulbar region with heart rate variability parameters HRV is heart rate variability. HRV, which is calculated from the intervals between normal heart beats

    Time frame: 5 months

  8. Correlation of the posterior nucleus volumes with the frequency of generalized seizures during the 12 months prior to enrollment

    Correlation of the posterior nucleus volumes with the frequency of generalized seizures during the 12 months prior to enrollment

    Time frame: 5 months

  9. Correlation of the anterior nucleus volumes with the frequency of generalized seizures during the 12 months prior to enrollment

    Correlation of the anterior nucleus volumes with the frequency of generalized seizures during the 12 months prior to enrollment

    Time frame: 5 months

  10. Correlation of the lateral nucleus volumes with the frequency of generalized seizures during the 12 months prior to enrollment

    Correlation of the lateral nucleus volumes with the frequency of generalized seizures during the 12 months prior to enrollment

    Time frame: 5 months

07

Study locations

1 of 1 sites recruiting
  • Amiens University Hospital
    Amiens, Picardie 80054, France
    • William SZURHAJ, Pr · Contact · szurhaj.william@chu-amiens.fr
    • Eva DIAB, MD · Sub investigator
    • Grégoire CAPELLIER, MD · Sub investigator
    • Bertille PERIN, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07888543
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Sep 10, 2026
Primary completion
Feb 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

William SZURHAJ, Pr
Contact
szurhaj.william@chu-amiens.fr
33+322087776

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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