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

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ClinicalTrials.gov Identifier: NCT03676543
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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.

Condition or disease Intervention/treatment Phase
Childhood or Juvenile Absence Epilepsy Procedure: Timed repetitive sensory stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mutual Interactions Between Absence Epilepsy Seizures and the Integration of Sensory Stimuli
Actual Study Start Date : June 7, 2018
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : April 15, 2020


Arm Intervention/treatment
Experimental: Timed repetitive sensory stimulation
Timed repetitive sensory stimulation (TRSS) will be applied at the onset or during seizures
Procedure: Timed repetitive sensory stimulation
Timed repetitive sensory stimulation (TRSS) will be applied at the onset or during seizures




Primary Outcome Measures :
  1. 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 ]
    Modification of the frequency within the peak-wave complexes according to the repeated sensory stimulation and the duration of the absence epilespy crisis

  2. Modification of the duration of the absence epilespy crisis according to the repeated sensory stimulation [ Time Frame: 1 hour ]
    Modification of the duration of the absence epilespy crisis according to the repeated sensory stimulation



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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676543


Contacts
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Contact: Amélie Yavchitz, MD, PhD 0148036454 ayavchitz@for.paris

Locations
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France
Fondation OPH A. de Rothschild Recruiting
Paris, France
Contact: Laurence SALOMON, MD PhD    0033148036431    lsalomon@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03676543     History of Changes
Other Study ID Numbers: MCX_2017_28
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Seizures
Epilepsy, Absence
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Epilepsy, Generalized
Epileptic Syndromes