Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP) (SUDEP)

April 1, 2019 updated by: Hospices Civils de Lyon
The mortality rate is increased in patients with epilepsy, and especially among patients with drug-resistant epilepsy. This increased mortality is mainly related to the risk of SUDEP whose incidence is between 3.5 and 9 per 1,000 for patients with drug-resistant epilepsy. The term SUDEP refers to a sudden death occurring in a patient with epilepsy in whom anamnestic and post-mortem evidence does not identify a particular cause. Experimental and clinical data strongly suggest that most of SUDEP result from a postictal respiratory dysfunction progressing to terminal apnea. Due to the major role of serotonin in regulating breathing rhythms and data in animal models of epilepsy, it is envisaged that an alteration of serotonergic systems of the brainstem and limbic regions may play a central role in the occurrence of SUDEP. The objective of this work is to look for abnormalities of the serotonergic transmission within regulatory regions of respiratory and autonomic functions in brain samples prospectively collected in patients died from SUDEP.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69008
        • Hospices Civils de Lyon - Institut Médico-Légal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with epilepsy who died

Description

Inclusion Criteria:

  • Age >18 years
  • Postmortem time before autopsy <30 hours

Exclusion Criteria:

  • Age <18 years
  • postmortem time before autopsy > 30 hours
  • Any subject whose brain would be of forensic interest
  • Any patient who expressed an opposition to organ donation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
diagnostic of SUDEP
patient with epilepsy in whom anamnestic and post-mortem evidence does not identify a particular cause (diagnosis of SUDEP). Brain samples and skin samples are collected.
Other: Brain samples
Collected in patients died
Other: Skin samples
Collected in patients died
Control 1
Subjects with a known epilepsy, whose death is linked to a specific cause. Brain samples and skin samples are collected.
Other: Brain samples
Collected in patients died
Other: Skin samples
Collected in patients died
Control 2
Subjects without known pathological history, remained victims of unexplained sudden unexpected death (SUDEP) after all investigations and for which a heart rhythm disorder is suspected in first intention. Brain samples and skin samples are collected.
Other: Brain samples
Collected in patients died
Other: Skin samples
Collected in patients died

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Density of Medullary 5-HT Neurons
Time Frame: between 1 to 30 hours following death
5-HT1A receptor binding density in within the medulla
between 1 to 30 hours following death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other markers of 5HT within the medulla
Time Frame: between 1 to 30 hours following death
Expression of 5HT-1A and 5HT-2 receptors, expression of 5HT transporter, Tryptophan Hydroxylase 2 (TPH2)
between 1 to 30 hours following death
Serotoninergic pathway in the pons, the hippocampus and the insula
Time Frame: between 1 to 30 hours following death
5-HT1A receptor binding density, Expression of 5HT-1A and 5HT-2 receptors, expression of 5HT transporter, Tryptophan Hydroxylase 2 (TPH2)
between 1 to 30 hours following death
Catecholaminergic pathway
Time Frame: between 1 to 30 hours following death
Number of neurons expressing the tyrosine hydroxylase, expression of alpha and beta adrenergic receptors, expression of dopamine-bêta-hydroxylase
between 1 to 30 hours following death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Actual)

April 3, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D50830

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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