ClinicalTrials.gg
TerminatedNCT03676543Absence SLIUpdated Sep 21, 2022

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

An interventional study of Timed repetitive sensory stimulation in Childhood or Juvenile Absence Epilepsy, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Terminated at 1 site in France. Open to participants aged 2 Years to 21 Years. Per ClinicalTrials.gov, last updated 2022-09-21.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Treatment

Why this study was terminated
This is the end of the inclusion period and only 1 patient has been recruited.
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
2 Years to 21 Years
Sex
All
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Study 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.

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Conditions studied

  • Childhood or Juvenile Absence Epilepsy

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03

In context

Epilepsy, Absence

28 studies on the registry are indexed under Epilepsy, Absence; 2 are open to participants now.

This study's enrollment of 1 is below the median of 20 across 20 interventional studies indexed under Epilepsy, Absence.

Browse Epilepsy, Absence studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 315 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 21 Years
Sexes eligible
All
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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Timed repetitive sensory stimulation

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

    Procedure: Timed repetitive sensory stimulation

Interventions

  • ProcedureTimed repetitive sensory stimulation

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 hour

  2. 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

    Time frame: 1 hour

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Study locations

1 site
  • Fondation OPH A. de Rothschild
    Paris, France
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2018 to primary completion in Aug 2022, 50 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2018
First posted
Sep 18, 2018
StartActual
Jun 7, 2018
Primary completionActual
Aug 29, 2022
CompletionActual
Aug 29, 2022
Last update
Sep 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03676543
Responsible party
Sponsor
First posted
Sep 18, 2018
Start date
Jun 7, 2018
Primary completion
Aug 29, 2022
Completion
Aug 29, 2022
Last update
Sep 21, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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