EpilepsyHYPOLEPSIENCT07888543
Study of the Link Between Structural Alterations in the Hypothalamus and Cardiac Dysautonomia in Drug-resistant Epilepsy
A study testing MRI scan and electrocardiogram in people with Epilepsy and Hypothalamus, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Hypothalamus, Seizures- Cardiac Dysautonomia
- What is being tested?
- MRI scan and electrocardiogram
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Amiens University Hospital
Amiens, Picardie, 80054
William SZURHAJ, Pr, szurhaj.william@chu-amiens.fr
Eva DIAB, MD
About this study
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.
- Conditions
- Epilepsy, Hypothalamus, Seizures- Cardiac Dysautonomia, SUDEP
- Being tested
- MRI scan, electrocardiogram
- Keywords
- Epilepsy, Hypothalamus, Seizures- Cardiac dysautonomia, SUDEP
- Medical subject headings
- Epilepsy, Sudden Unexpected Death in Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanOther
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.
electrocardiogramOther
Heart rate variability parameters will be calculated from the patients' electrocardiograms, performed as part of their care under the supervision of Prof. Szurhaj.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 months
Secondary outcomes (10)
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
Measured: 5 months
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
Measured: 5 months
correlation of the posterior nucleus volumes with the risk of SUDEP
correlation of the posterior nucleus volumes with the risk of SUDEP
Measured: 5 months
correlation of the lateral nucleus volumes with the risk of SUDEP
correlation of the lateral nucleus volumes with the risk of SUDEP
Measured: 5 months
correlation of the anterior nucleus volumes with the risk of SUDEP
correlation of the anterior nucleus volumes with the risk of SUDEP
Measured: 5 months
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
Measured: 5 months
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
Measured: 5 months
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
Measured: 5 months
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
Measured: 5 months
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
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start10 Sep 2026
- Primary completionFeb 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888543
- Sponsor's protocol ID
- PI2025_843_0217
- Acronym
- HYPOLEPSIE
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Link Between Structural Alterations in the Hypothalamus and Cardiac Dysautonomia in Drug-resistant Epilepsy
- ClinicalTrials.gov ID
- NCT07888543
- Acronym / sponsor ID
- HYPOLEPSIE / PI2025_843_0217
- Conditions
- Epilepsy, Hypothalamus, Seizures- Cardiac Dysautonomia, SUDEP
- Keywords
- Epilepsy, Hypothalamus, Seizures- Cardiac dysautonomia, SUDEP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 10 Sep 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scanPatients 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. | Other | – |
| electrocardiogramHeart rate variability parameters will be calculated from the patients' electrocardiograms, performed as part of their care under the supervision of Prof. Szurhaj. | Other | – |
Primary outcome
Correlation coefficient between the volume of the posterior hypothalamic nucleus with the degree of cardiac autonomic function impairment
Time frame: 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
10 secondary outcomes
correlation of anterior nucleus volumes with HRV parameters
Time frame: 5 months
correlation of lateral nucleus volumes with HRV parameters
Time frame: 5 months
correlation of the posterior nucleus volumes with the risk of SUDEP
Time frame: 5 months
correlation of the lateral nucleus volumes with the risk of SUDEP
Time frame: 5 months
correlation of the anterior nucleus volumes with the risk of SUDEP
Time frame: 5 months
correlation of structural connectivity values with heart rate variability parameters
Time frame: 5 months
Correlation of metabolic values of the hypothalamus and the bulbar region with heart rate variability parameters
Time frame: 5 months
Correlation of the posterior nucleus volumes with the frequency of generalized seizures during the 12 months prior to enrollment
Time frame: 5 months
Correlation of the anterior nucleus volumes with the frequency of generalized seizures during the 12 months prior to enrollment
Time frame: 5 months
Correlation of the lateral nucleus volumes with the frequency of generalized seizures during the 12 months prior to enrollment
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI scan and electrocardiogram in people with Epilepsy and Hypothalamus, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William SZURHAJ, Pr (33+322087776, szurhaj.william@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient between the volume of the posterior hypothalamic nucleus with the degree of cardiac autonomic function impairment (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.