Evaluation of the Effect of a Single Dose of Psilocybin on Neural Correlates of Cognitive Control… (NCT06647056) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Effect of a Single Dose of Psilocybin on Neural Correlates of Cognitive Control in Patients With Psychogenic Nonepileptic Seizures
France4 participantsStarted 2024-12-19
Plain-language summary
Psychogenic non-epileptic seizures (PNES) are functional paroxysmal motor disorders that may be clinically suggestive of epilepsy but are not associated with the electroencephysiological and electroencephalographic changes of epilepsy. Thus, hyper-connectivity of the regions of the default mode network (DMN) linked to executive control could be involved in the impairment of cognitive control capacities in patients suffering from PNES. Also, the HYCORE study (NCT02329626), showed that dysregulation of frontal regions involved in attentional and emotional regulation is correlated with motor symptoms in patients with functional neurological disorders.
The researchers of this study hypothesized that psilocybin would improve cognitive control in patients with PNES.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Euthymic patient according to the MINI questionnaire.
* Diagnosis of PNES confirmed by video-EEG, progressing for more than 3 months, and meeting DSM5 criteria.
* Normal brain MRI during the assessment as part of routine care
* No contraindication to stopping any antidepressant treatment for a fortnight (or 5 weeks for fluoxetine) prior to the administration of psilocybin. Other psychotropic treatments will not be interrupted.
* Patient must have given their free and informed consent and signed the consent form
* Patient must be a member of beneficiary of a health insurance plan
* Patient available for a total of 6 months follow-up.
* Good physical health and absence of unstable medical pathology. These pathologies include cardiovascular co-morbidities: history of stroke, myocardial infarction, heart failure, arrhythmia, uncontrolled hypertension (greater than 165/95 mmHg at screening); organic epileptic syndrome and active neurological comorbidities; endocrine pathologies (dysthyroid and adrenal insufficiency, type 1 diabetes or insulin-requiring type II diabetes, history of severe hypoglycaemia requiring hospital treatment); considerable impairment of liver function; glaucoma; symptomatic prostatic hypertrophy or bladder neck obstruction.
* Ability to understand and speak French
Exclusion Criteria:
* Serious risk of suicide according to the clinician opinion.
* High risk of adverse emotional or behavioural reaction as clinically assessed by the inve…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Emotional distraction in PNES patients receiving psilocybin
Timeframe: Three days before psilocybin treatment
2
Emotional distraction in PNES patients receiving psilocybin