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Clinical Trials/NCT02460965
NCT02460965
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Not Applicable

Understanding Hallucinations (Part II) - fMRI and EEG

Iris Sommer1 site in 1 country240 target enrollmentNovember 2013
ConditionsHallucinations

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hallucinations
Sponsor
Iris Sommer
Enrollment
240
Locations
1
Primary Endpoint
Difference in fMRI resting state correlates between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes.
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
March 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Iris Sommer

Prof.Dr.

UMC Utrecht

Eligibility Criteria

Inclusion Criteria

  • Previous participation in the phenomenology/cognition study 13-
  • Belong to one of the diagnostic groups as described above in 4.
  • Written informed consent

Exclusion Criteria

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

Outcomes

Primary Outcomes

Difference in fMRI resting state correlates between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes.

Time Frame: Three years

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.

Secondary Outcomes

  • The difference in EEG correlates between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes.(Three years)
  • The auditory and visual cortex responsiveness patterns between hallucinating individuals of different subtypes.(Three years)

Study Sites (1)

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