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

NCT02788318 | Terminated

• 1 other identifier: D50830
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sudden Unexpected Death in Epilepsy (SUDEP)

Keywords

Epilepsy; SUDEP; Serotonin

Outcome Measures

Primary Outcomes (1)

• Density of Medullary 5-HT Neurons

  5-HT1A receptor binding density in within the medulla

  between 1 to 30 hours following death

Secondary Outcomes (3)

• Other markers of 5HT within the medulla

  between 1 to 30 hours following death

• Serotoninergic pathway in the pons, the hippocampus and the insula

  between 1 to 30 hours following death

• Catecholaminergic pathway

  between 1 to 30 hours following death

Study Arms (3)

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; Other: Skin samples

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; Other: Skin samples

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; Other: Skin samples

Interventions

Brain samples OTHER

Collected in patients died

Control 1; Control 2; diagnostic of SUDEP

Skin samples OTHER

Collected in patients died

Control 1; Control 2; diagnostic of SUDEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with epilepsy who died

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Institut Médico-Légal

Lyon, 69008, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Brain tissue (brainstem, hippocampus and insula) and fibroblasts culture

MeSH Terms

Conditions

Sudden Unexpected Death in Epilepsy; Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 2, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

FR (1)