Neuronal Excitability of HCN1 Channel Mutations in Dravet Syndrome (EXCIDRAH)

February 14, 2023 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Neuronal Excitability of Hyperpolarization-activated Cyclic Nucleotide-gated (HCN1) Channel Mutations in Dravet Syndrome

This study addresses the changes in the axonal excitability parameters. It will compare these changes in patients with early infantile epileptic encephalopathy with HCN1 channel mutation and in control patients, with and without epilepsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

92

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
      • Paris, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild

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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with Dravet syndrome and control patients with and without epilepsy.

Description

Inclusion Criteria:

  • early infantile epileptic encephalopathy with HCN1 channel mutation
  • control patients with no neurologic pathology (age, gender and body temperature matched)
  • epileptic patients (age, gender and body temperature matched)

Exclusion Criteria:

  • pregnant or breast feeding patient

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: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dravet syndrome - HCN1 channel mutation
early infantile epileptic encephalopathy with HCN1 channel mutation
Device: measure of neuronal excitability
control with epilepsy
Device: measure of neuronal excitability
control without epilepsy
Device: measure of neuronal excitability

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hyperpolarizing electrotonus
Time Frame: baseline
baseline
hyperpolarizing threshold current
Time Frame: baseline
baseline

Collaborators and Investigators

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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

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)

October 29, 2015

Primary Completion (Actual)

October 16, 2019

Study Completion (Actual)

October 16, 2019

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGN_2015_11

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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