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CompletedNot applicable

Characterization of Altered Waking States of Consciousness in Healthy Humans

NCT03853577 · University of Zurich

Closed to entry
Status
Not accepting participants
Not applicable
Phase
25
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Altered waking states of consciousness and its underlying functional organization have gained increasing interest in recent years, i.e. in identifying the neural basis of consciousness. To overcome fundamental shortcomings of current methods to objectively assess the level of consciousness, the investigators propose here to apply a novel and empirically validated measure called 'perturbational complexity index' (PCI) based on the integrated information theory (IIT). This involves a combination of transcranial magnetic stimulation (TMS) and highdensity electroencephalography (hd-EEG) to measure electrocortical responses as distributed cerebral interactions ('integration') and spatiotemporal pattern ('information'). Given the finding of subjectively expanded consciousness as induced here by psilocybin, the investigators hypothesize that the PCI may be higher in such states. This will be the first TMS/hd-EEG study to investigate quantitatively the level of consciousness in a pharmacologically altered waking state of consciousness.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Assessment of change of the 'perturbational complexity index' (PCI) in psilocybin compared to placebo condition in healthy humans as indexed by TMS/EEG respones

    Measured over First investigational visit at week 1, second investigational visit at week 3

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 40 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Healthy male or female volunteers aged 18-40 years Exclusion Criteria: * Personal and family history of major psychiatric disease (e.g. major depression, bipolar disorder, psychotic disorder) as defined in the DSM-V * Any major medical condition (e.g. neurologic, cardiovascular, metabolic disease), family history of seizure disorder * Current psychopharmacological treatment / use of medication * Pregnant or breastfeeding women

Where

1 study site

FacilityCityRegionCountry
Psychiatrische Universitätsklinik ZürichZurichSwitzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT03853577 on ClinicalTrials.gov →

Last updated in the registry 2021-04-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits