Psychogenic seizure Trials in Disease

Study on the Effects of Psilocybin for Patients with Psychogenic Non-Epileptic Seizures (PNES)

This trial is investigating how a single dose of psilocybin affects brain activity in patients who experience psychogenic non-epileptic seizures. These are episodes that look like epileptic seizures but are not caused by abnormal electrical activity in the brain. Instead, they are often linked to psychological factors such as stress or trauma.

Main inclusion criteria:

• Adults between 18 and 60 years old
• Confirmed diagnosis of psychogenic non-epileptic seizures through video-EEG testing, with symptoms present for more than 3 months
• Able to speak and understand French
• Normal brain MRI scan
• In stable mood as determined by a specific questionnaire
• Able to stop antidepressant medication for two weeks before treatment (or five weeks for fluoxetine)
• Good physical health without unstable medical conditions such as heart problems, epilepsy, uncontrolled diabetes, significant liver problems, glaucoma, or prostate/bladder issues
• Available for 6-month follow-up period

Main exclusion criteria:

• Individuals belonging to vulnerable populations who may have limited ability to protect their own interests
• Presence of certain medical conditions that could affect safety during the trial

Focus and goal of the trial:

The main goal is to understand how psilocybin influences brain activity related to cognitive control, which is the brain's ability to manage thoughts, emotions, and actions. Researchers will use MRI scanning to observe changes in brain regions involved in emotional processing and decision-making. Participants will complete an emotional task called the Go-No Go task before and after receiving psilocybin to measure these changes.

The study follows a specific timeline: participants undergo baseline brain imaging three days before receiving psilocybin, then receive a single oral dose of the medication. Five days later, the same brain imaging and cognitive tests are repeated. Follow-up assessments continue at one month and three months to track changes in seizure frequency and related symptoms over time.

Investigational drug:

The trial uses psilocybin, a substance that interacts with serotonin receptors in the brain. It is administered as a single oral dose in capsule form. Psilocybin is being studied for its potential to alter brain activity patterns involved in emotional processing and cognitive control, which researchers believe may help manage symptoms in people with psychogenic non-epileptic seizures.