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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Administration of psilocybin 25 mg
Two standard MRI + fMRI scans before (D-3) and after (D5) treatment
CHU de Nîmes, Hôpital Universitaire Carémeau
Nîmes, France
Emotional distraction in PNES patients receiving psilocybin
Fluctuation du signal BOLD (Blood-oxygen level dependence) during a Go-No Go test
Time frame: Three days before psilocybin treatment
Emotional distraction in PNES patients receiving psilocybin
Fluctuation du signal BOLD (Blood-oxygen level dependence) during a Go-No Go test
Time frame: Five days after psilocybin treatment
Resting-state activity in brain regions involved in cognitive control in PNES patients receiving psilocybin
Fluctuation of the BOLD (Blood-oxygen level dependent) signal for each independent component (Image grey levels).
Time frame: Three days before psilocybin treatment
Resting-state activity in brain regions involved in cognitive control in PNES patients receiving psilocybin
Fluctuation of the BOLD (Blood-oxygen level dependent) signal for each independent component (Image grey levels).
Time frame: Five days after psilocybin treatment
Resting-state activity in brain regions of the default mode network (DMN) in patients with PNES receiving psilocybin.
Blood-oxygen level dependent (BOLD) signal synchronisation levels in brain regions DMN (grey levels of the image).
Time frame: Three days before psilocybin treatment
Resting-state activity in brain regions of the default mode network (DMN) in patients with PNES receiving psilocybin.
Blood-oxygen level dependent (BOLD) signal synchronisation levels in brain regions DMN (grey levels of the image).
Time frame: Five days after psilocybin treatment
Cognitive control abilities in patients with PNES receiving psilocybin
emotional Go-No Go error rate (%)
Time frame: Three days before psilocybin treatment
Cognitive control abilities in patients with PNES receiving psilocybin
emotional Go-No Go error rate (%)
Time frame: Five days after psilocybin treatment
Cognitive control abilities in patients with PNES receiving psilocybin
neutral Go-No Go task response latency (ms)
Time frame: Three days before psilocybin treatment
Cognitive control abilities in patients with PNES receiving psilocybin
neutral Go-No Go task response latency (ms)
Time frame: Five days after psilocybin treatment
Number of PNES over a 3-month period in patients with PNES receiving psilocybin
Number
Time frame: Day 0
Number of PNES over a 3-month period in patients with PNES receiving psilocybin
Number
Time frame: Month 3
Functional impact of PNES in patients with PNES receiving psilocybin
Clinical Global Impression: Score 0-7; cut-off: 4 = unchanged or worse and the secondary effects take over the therapeutic effects
Time frame: Three days before psilocybin treatment
Functional impact of PNES in patients with PNES receiving psilocybin
Clinical Global Impression: Score 0-7; cut-off: 4 = unchanged or worse and the secondary effects take over the therapeutic effects
Time frame: Five days after psilocybin treatment
Functional impact of PNES in patients with PNES receiving psilocybin
Clinical Global Impression: Score 0-7; cut-off: 4 = unchanged or worse and the secondary effects take over the therapeutic effects
Time frame: Month 1
Functional impact of PNES in patients with PNES receiving psilocybin
Clinical Global Impression: Score 0-7; cut-off: 4 = unchanged or worse and the secondary effects take over the therapeutic effects
Time frame: Month 3
Dissociative symptoms in patients with PNES receiving psilocybin
Dissociation Experience Scale: Score 0-100; cut-off: 30 or more shows the presence of dissociative troubles.
Time frame: Three days before psilocybin treatment
Dissociative symptoms in patients with PNES receiving psilocybin
Dissociation Experience Scale: Score 0-100; cut-off: 30 or more shows the presence of dissociative troubles.
Time frame: Five days after psilocybin treatment
Dissociative symptoms in patients with PNES receiving psilocybin
Dissociation Experience Scale: Score 0-100; cut-off: 30 or more shows the presence of dissociative troubles.
Time frame: Month 1
Dissociative symptoms in patients with PNES receiving psilocybin
Dissociation Experience Scale: Score 0-100; cut-off: 30 or more shows the presence of dissociative troubles.
Time frame: Month 3
Tolerance of psilocybin in patients with PNES receiving psilocybin
5-Dimensional Altered States of Consciousness Rating Scale: Score 0-100; more than 25 = higher probability to have a dissociative trouble.
Time frame: Day 0
Tolerance of psilocybin in patients with PNES receiving psilocybin
5-Dimensional Altered States of Consciousness Rating Scale: Score 0-100; more than 25 = higher probability to have a dissociative trouble.
Time frame: Five days after psilocybin treatment
Tolerance of psilocybin in patients with PNES receiving psilocybin
5-Dimensional Altered States of Consciousness Rating Scale: Score 0-100; more than 25 = higher probability to have a dissociative trouble.
Time frame: Month 1
Tolerance of psilocybin in patients with PNES receiving psilocybin
5-Dimensional Altered States of Consciousness Rating Scale: Score 0-100; more than 25 = higher probability to have a dissociative trouble.
Time frame: Month 3
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