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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03676543
Other study ID # MCX_2017_28
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 7, 2018
Est. completion date August 29, 2022

Study information

Verified date September 2022
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date August 29, 2022
Est. primary completion date August 29, 2022
Accepts healthy volunteers No
Gender All
Age group 2 Years to 21 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Fondation OPH A. de Rothschild Paris

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 hour
Primary 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 1 hour