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Understanding Hallucinations (Part II)

Understanding Hallucinations (Part II) - fMRI and EEG

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02460965
Acronym
UH-2
Enrollment
240
Registered
2015-06-03
Start date
2013-11-30
Completion date
2017-03-31
Last updated
2016-10-26

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

Conditions

Hallucinations

Brief summary

Rationale: Hallucinations occur in many patients with different kinds of diseases, including psychiatric, neurological and perceptual impairment. The origin of these hallucinations is only partly understood. This prevents correct prediction of treatment response and hampers the development of new, more effective treatment strategies. Different subtypes of hallucinations resulting from different neuropathology may exist across diagnostic entities, and be responsive to different treatment strategies. Understanding the origin of these subtypes with use of fMRI and EEG can help to make rational treatment decisions on an individual basis and enhance the development of innovative treatment paradigms. Objective: The primary objective is to find specific abnormalities on resting state fMRI related to the pathophysiology of different subtypes of hallucinations. Secondary objectives are to find EEG connectivity measures that are related to the pathophysiology of different subtypes of hallucinations, reveal correlating patterns of EEG and fMRI that underlie the experience of hallucinations across different disorders, and to examine the frequency of spontaneous synchronized burst activations in auditory and visual cortices using fMRI. Study design: The investigators intend to examine neural correlates of hallucinations over different disorders using resting state EEG, fMRI and sMRI in an observational study. Study population: A total of 140 hallucinating patients will be included, 20 of each of the 7 different diagnostic groups. As a control group, 140 non-hallucinating patients with the same disorder of similar severity will be included. Main study parameters/endpoints: The main study endpoint is the difference in resting state correlates as measured with fMRI between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes, namely: connectivity within the DMN and connectivity of the DMN to sensory cortices and the hippocampal-amygdala complex. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in the study will entail an MRI scan of 40 minutes and an EEG measurement of 5 minutes. Total visit time, including preparations, will be approximately 2,5 hours. The risks associated with participation and the benefits to the individuals are negligible. The potential benefit to society in the future is considerable if the findings lead to optimization of treatment strategies and treatment response.

Interventions

None listed

Sponsors

Iris Sommer
Lead SponsorOTHER

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Previous participation in the phenomenology/cognition study 13-059. * Belong to one of the diagnostic groups as described above in 4.1. * Written informed consent

Exclusion criteria

* \< 18 years of age * Any contraindication for a 3Tesla MRI scan

Design outcomes

Primary

MeasureTime frameDescription
Difference in fMRI resting state correlates between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes.Three yearsThe main study endpoint is the difference in resting state correlates as measured with fMRI between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes, namely: connectivity within the DMN and connectivity of the DMN to sensory cortices and the hippocampal-amygdala complex.

Secondary

MeasureTime frameDescription
The difference in EEG correlates between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes.Three yearsThe differences in EEG spectral analysis, synchronization likelihood, clustering index, path lengths and assortativity between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes.
The auditory and visual cortex responsiveness patterns between hallucinating individuals of different subtypes.Three yearsThe frequency of spontaneous synchronized burst activations in auditory and visual cortices

Other

MeasureTime frameDescription
Cardio-respiratory rhythms to correct for cardio-respiratory processes in the fMRI signal.Three yearsIn order to remove cardiac and respiratory pulsality effects that contaminate BOLD fMRI time series, cardiac signals and respiration will be measured

Countries

Netherlands

Contacts

Primary ContactSanne Koops, Msc.
S.Koops@umcutrecht.nl+31887558672

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026