This open-label interventional trial (n=10) will evaluate the effect of a single 25 mg dose of psilocybin on neural correlates of cognitive control in patients with psychogenic non-epileptic seizures (PNES).
Conducted by the Centre Hospitalier Universitaire de Nîmes, this study aims to investigate whether psilocybin can enhance cognitive control in PNES patients by modulating brain activity in key executive control regions.
Participants will undergo MRI and fMRI scans before and after psilocybin administration to assess changes in blood-oxygen level-dependent (BOLD) signal fluctuations. The study will also examine the impact of psilocybin on emotional regulation, cognitive performance, seizure frequency, dissociative symptoms, and overall functional outcomes over a three-month period. Primary completion is estimated by May 2026, with full study completion expected in August 2026.
Trial Details
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.Trial Number NCT06647056