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Evaluation of the effect of a single dose of psilocybin on neural correlates of cognitive control in patients with CNEP (psychogenic nonepileptic seizures): a single-arm, open-label pilot study.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509679-17-00
Acronym
NIMAO/2022-2/IC-01
Enrollment
10
Registered
2024-05-22
Start date
2024-11-05
Completion date
Unknown
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psychogenic non-epileptic seizures

Brief summary

Quantification of changes in the activity of the cognitive control network on functional brain MRI during an emotional Go-No Go task (described by Fauvé et al. (2022)) performed before (D-3) and after (D+5) psilocybin administration

Detailed description

Changes in brain activity on resting-state functional brain MRI of the cognitive control network before (D-3) and after (D+5) psilocybin administration., Changes in brain activity on resting-state MRI of the Default-Mode Network (DMN) before (D-3) and after (D+5) psilocybin administration., Collection of the number of errors (n) and measurement of response latency (ms) during an emotional Go-No Go task before (D-3) and after (D+5) psilocybin administration., Collection of the number of errors (n) and measurement of response latency (ms) during a neutral Go-No Go task before (D-3) and after (D+5) psilocybin administration., Measurement of the frequency of CNEP in the 6 weeks before and after psilocybin administration using a seizure diary., Measurement of changes in the CGI-CNEP scale before (D-3) and after (D+5, M1 and M3) psilocybin administration; scoring by the neurologist and psychiatrist., Measurement of changes in dissociative symptomatology using the DES scale before (D-45, D-3) and after (D+5, M1 and M3) psilocybin administration., Administration of the 5D-ASC (5-Dimensional Altered States of Consciousness Questionnaire) at D0 then D+5, M1 and M3 after psilocybin administration..

Interventions

Sponsors

Centre Hospitalier Universitaire De Nimes
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Quantification of changes in the activity of the cognitive control network on functional brain MRI during an emotional Go-No Go task (described by Fauvé et al. (2022)) performed before (D-3) and after (D+5) psilocybin administration

Secondary

MeasureTime frame
Changes in brain activity on resting-state functional brain MRI of the cognitive control network before (D-3) and after (D+5) psilocybin administration., Changes in brain activity on resting-state MRI of the Default-Mode Network (DMN) before (D-3) and after (D+5) psilocybin administration., Collection of the number of errors (n) and measurement of response latency (ms) during an emotional Go-No Go task before (D-3) and after (D+5) psilocybin administration., Collection of the number of errors (n) and measurement of response latency (ms) during a neutral Go-No Go task before (D-3) and after (D+5) psilocybin administration., Measurement of the frequency of CNEP in the 6 weeks before and after psilocybin administration using a seizure diary., Measurement of changes in the CGI-CNEP scale before (D-3) and after (D+5, M1 and M3) psilocybin administration; scoring by the neurologist and psychiatrist., Measurement of changes in dissociative symptomatology using the DES scale before (D-45, D-3)

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026