Hallucinations Clinical Trial
— UH-2Official title:
Understanding Hallucinations (Part II) - fMRI and EEG
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | March 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Netherlands | UMC Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
Iris Sommer |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cardio-respiratory rhythms to correct for cardio-respiratory processes in the fMRI signal. | In order to remove cardiac and respiratory pulsality effects that contaminate BOLD fMRI time series, cardiac signals and respiration will be measured | Three years | No |
Primary | Difference in fMRI resting state correlates between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes. | 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. | Three years | No |
Secondary | The difference in EEG correlates between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes. | The 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. | Three years | No |
Secondary | The auditory and visual cortex responsiveness patterns between hallucinating individuals of different subtypes. | The frequency of spontaneous synchronized burst activations in auditory and visual cortices | Three years | No |
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