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

NCT ID: NCT02788318

Last Updated: 2019-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sudden Unexpected Death in Epilepsy (SUDEP)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Brain samples

Intervention Type OTHER

Collected in patients died

Skin samples

Intervention Type OTHER

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.

Brain samples

Intervention Type OTHER

Collected in patients died

Skin samples

Intervention Type OTHER

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.

Brain samples

Intervention Type OTHER

Collected in patients died

Skin samples

Intervention Type OTHER

Collected in patients died

Interventions

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Brain samples

Collected in patients died

Intervention Type OTHER

Skin samples

Collected in patients died

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civils de Lyon - Institut Médico-Légal

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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D50830

Identifier Type: -

Identifier Source: org_study_id

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