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Mutual Interactions Between Absence Epilepsy Seizures and the Integration of Sensory Stimuli (Absence SLI)

Primary Purpose

Childhood or Juvenile Absence Epilepsy

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Timed repetitive sensory stimulation
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood or Juvenile Absence Epilepsy

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria :

  • Age 2-20 years
  • childhood or juvenile absence epilepsy defined by International Ligue Against Epilepsy (ILAE)
  • Electroencephalogram (EEG) indicated for clinical follow-up

Non inclusion criteria:

  • Visual deficit
  • Abnormal Magnetic Resonance Imaging (MRI)
  • Medical history of photosensitive epileptic seizures

Sites / Locations

  • Fondation OPH A. de Rothschild

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Timed repetitive sensory stimulation

Arm Description

Timed repetitive sensory stimulation (TRSS) will be applied at the onset or during seizures

Outcomes

Primary Outcome Measures

Modification of the frequency within the peak-wave complexes according to the repeated sensory stimulation and the duration of the absence epilespy crisis
Modification of the frequency within the peak-wave complexes according to the repeated sensory stimulation and the duration of the absence epilespy crisis
Modification of the duration of the absence epilespy crisis according to the repeated sensory stimulation
Modification of the duration of the absence epilespy crisis according to the repeated sensory stimulation

Secondary Outcome Measures

Full Information

First Posted
July 31, 2018
Last Updated
September 19, 2022
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT03676543
Brief Title
Mutual Interactions Between Absence Epilepsy Seizures and the Integration of Sensory Stimuli
Acronym
Absence SLI
Official Title
Mutual Interactions Between Absence Epilepsy Seizures and the Integration of Sensory Stimuli
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
This is the end of the inclusion period and only 1 patient has been recruited.
Study Start Date
June 7, 2018 (Actual)
Primary Completion Date
August 29, 2022 (Actual)
Study Completion Date
August 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Epileptic seizures arise from neuronal defects that often alter the capacity of the brain to process sensory information. During absence seizures, a frequent epileptic syndrome in children, the normal conscious and perceptual processes are temporarily interrupted. This is the result of abnormal synchronized neural activities in the thalamo-cortical loops, leading to bilateral spike-and-wave discharges (SWDs) in the cortical electroencephalograms (EEGs). The brain mechanisms underlying the lack of sensory experience during absence seizures are disputed. Based on preliminary data, the investigators hypothesize that the alternation of 'spike' and 'wave' patterns during seizure could cause a time-to-time inconstancy in cortical responsiveness, preventing conscious perception. Using a real-time closed-loop stimulation system, the investigators will research how the S- and W-patterns specifically alter the sensory-evoked responses in the EEG. During a standard EEG, visual stimulations will be applied between and during absence seizures to test the hypothesis that repeated sensory stimuli, applied with an appropriate timing relative to the seizure-related oscillatory cycle, could negatively interfere with the regenerative network mechanisms involved in the occurrence of SWDs. The completion of this project should permit to unveil a new neuronal mechanism supporting the lack of conscious experience during absences and pave the way for new clinical non-invasive strategies to interrupt ongoing seizure activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood or Juvenile Absence Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Timed repetitive sensory stimulation
Arm Type
Experimental
Arm Description
Timed repetitive sensory stimulation (TRSS) will be applied at the onset or during seizures
Intervention Type
Procedure
Intervention Name(s)
Timed repetitive sensory stimulation
Intervention Description
Timed repetitive sensory stimulation (TRSS) will be applied at the onset or during seizures
Primary Outcome Measure Information:
Title
Modification of the frequency within the peak-wave complexes according to the repeated sensory stimulation and the duration of the absence epilespy crisis
Description
Modification of the frequency within the peak-wave complexes according to the repeated sensory stimulation and the duration of the absence epilespy crisis
Time Frame
1 hour
Title
Modification of the duration of the absence epilespy crisis according to the repeated sensory stimulation
Description
Modification of the duration of the absence epilespy crisis according to the repeated sensory stimulation
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria : Age 2-20 years childhood or juvenile absence epilepsy defined by International Ligue Against Epilepsy (ILAE) Electroencephalogram (EEG) indicated for clinical follow-up Non inclusion criteria: Visual deficit Abnormal Magnetic Resonance Imaging (MRI) Medical history of photosensitive epileptic seizures
Facility Information:
Facility Name
Fondation OPH A. de Rothschild
City
Paris
Country
France

12. IPD Sharing Statement

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Mutual Interactions Between Absence Epilepsy Seizures and the Integration of Sensory Stimuli

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