Understanding Hallucinations (Part II)

NCT ID: NCT02460965

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hallucinations

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with schizophrenia

No interventions assigned to this group

Patients with borderline personality disorder

No interventions assigned to this group

Patients with hearing impairment

No interventions assigned to this group

Patients with visual loss

No interventions assigned to this group

Patients with Parkinson's Disease

No interventions assigned to this group

Patients with Alzheimer's Disease

No interventions assigned to this group

Patients with dementia with Lewy Bodies

No interventions assigned to this group

Healthy participants

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Iris Sommer

OTHER

Sponsor Role lead

Responsible Party

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Iris Sommer

Prof.Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Iris Sommer, Prof, Dr.

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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UMC Utrecht

Utrecht, Utrecht, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Sanne Koops, Msc.

Role: CONTACT

Phone: +31887558672

Email: [email protected]

Facility Contacts

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Sanne Koops, Msc.

Role: primary

Other Identifiers

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UH-2

Identifier Type: -

Identifier Source: org_study_id