Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask

Study Overview
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Brief Summary
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By enabling a partial rebreathing of expired gas, a moderate respiratory acidosis is induced, without causing hypoxia in the patient. Based on the scientific literature on the subject, the study hypothesis is that the fall in body pH will be able to stop and/or prevent epileptic brain activity.

Official Title
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Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask

Conditions
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Epilepsy

Intervention / Treatment
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* Device: CDA Mask
* Device: Dummy mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Epilepsy 18-80 years Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tonic-clonic seizures<br>Patients with tonic-clonis seizures are observed in a video/EEG room. In the case of seizures, the treatment mask or dummy mask are administered, according to a randomized cross-over study design. | Device: CDA Mask<br>* The CDA (Carbon Dioxide Accumulation) mask effectuates an increase in the inspired CO2 fraction, while allowing an adequate supply of fresh air to the patient.<br>Device: Dummy mask<br>* The dummy mask is similar in appearance to the treatment mask, but causes only a negligible change in blood gases<br>|
| Experimental: Generalized Paroxysms<br>Patients with generalized epileptic paroxysms are observed by EEG during baseline, treatment mask and dummy mask use, according to a randomized cross-over study design. | Device: CDA Mask<br>* The CDA (Carbon Dioxide Accumulation) mask effectuates an increase in the inspired CO2 fraction, while allowing an adequate supply of fresh air to the patient.<br>Device: Dummy mask<br>* The dummy mask is similar in appearance to the treatment mask, but causes only a negligible change in blood gases<br>|
| Experimental: Group 3<br>Patients with epileptic paroxysms are observed by EEG during baseline, treatment mask and dummy mask use, according to a randomized cross-over study design. | Device: CDA Mask<br>* The CDA (Carbon Dioxide Accumulation) mask effectuates an increase in the inspired CO2 fraction, while allowing an adequate supply of fresh air to the patient.<br>Device: Dummy mask<br>* The dummy mask is similar in appearance to the treatment mask, but causes only a negligible change in blood gases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of epileptic seizure (subgroup 1) | Length of epileptic seizure with treatment mask vs. dummy mask | Duration of mask treatment during acute seizures: approx. 3 minutes from start of mask treatment until end of seizure | 
| Frequency of epileptic paroxysms (subgroups 2 and 3) | Frequency of epileptic paroxysms as measured by EEG, treatment mask vs. dummy mask | Duration of mask treatment: 45 minutes (group 2) or 10 minutes (group 3) during which patient is monitored with EEG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen saturation during mask treatment | Measures oxygen saturation using a pulse oximeter during mask treatment | Duration of mask treatment |