Childhood or Juvenile Absence EpilepsyAbsence SLINCT03676543
Mutual Interactions Between Absence Epilepsy Seizures and the Integration of Sensory Stimuli
A study testing Timed repetitive sensory stimulation in people with Childhood or Juvenile Absence Epilepsy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Childhood or Juvenile Absence Epilepsy
- What is being tested?
- Timed repetitive sensory stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2018to 29 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Childhood or Juvenile Absence Epilepsy
- Being tested
- Timed repetitive sensory stimulation
- Medical subject headings
- Epilepsy, Absence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timed repetitive sensory stimulationProcedure or surgery
Timed repetitive sensory stimulation (TRSS) will be applied at the onset or during seizures
| Study group | Role | What they receive |
|---|---|---|
| Timed repetitive sensory stimulation | Experimental | Timed repetitive sensory stimulation (TRSS) will be applied at the onset or during seizures Receives: Procedure: Timed repetitive sensory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start7 Jun 2018
- Primary completion29 Aug 2022
- Study completion29 Aug 2022
Why it stopped: This is the end of the inclusion period and only 1 patient has been recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood or Juvenile Absence EpilepsyStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676543
- Sponsor's protocol ID
- MCX_2017_28
- Acronym
- Absence SLI
- Status last verified
- Sep 2022
- First submitted
- 31 Jul 2018
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mutual Interactions Between Absence Epilepsy Seizures and the Integration of Sensory Stimuli
- ClinicalTrials.gov ID
- NCT03676543
- Acronym / sponsor ID
- Absence SLI / MCX_2017_28
- Conditions
- Childhood or Juvenile Absence Epilepsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This is the end of the inclusion period and only 1 patient has been recruited.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Timed repetitive sensory stimulation | Experimental | Procedure: Timed repetitive sensory stimulationTimed repetitive sensory stimulation (TRSS) will be applied at the onset or during seizures |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age 2-20 years
- childhood or juvenile absence epilepsy defined by International Ligue Against Epilepsy (ILAE)
- Electroencephalogram (EEG) indicated for clinical follow-up
- Visual deficit
- Abnormal Magnetic Resonance Imaging (MRI)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timed repetitive sensory stimulationTimed repetitive sensory stimulation (TRSS) will be applied at the onset or during seizures | Procedure or surgery | Timed repetitive sensory stimulation |
Primary outcome
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
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
Results and safety
The study was stopped early (reason given: This is the end of the inclusion period and only 1 patient has been recruited.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timed repetitive sensory stimulation in people with Childhood or Juvenile Absence Epilepsy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This is the end of the inclusion period and only 1 patient has been recruited.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022; AzTrials last refreshed its copy on 1 Nov 2026.