Understanding Hallucinations (Part II) (UH-2)

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.

Study Overview

• Status: Unknown
• Conditions: Hallucinations

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Recruiting
    • UMC Utrecht
    • Contact: Sanne Koops, Msc.; Phone Number: +31 8858672; Email: S.koops@umcutrecht.nl
    • Principal Investigator: Iris EC Sommer, Prof.Dr.
    • Sub-Investigator: Sanne Koops, Msc.
    • Sub-Investigator: Remko van Lutterveld, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The participants will consist of 7 different diagnostic categories. Individuals with hallucinations will have to experience at least one episode of hallucinations over the last month. The control group will consist of non-hallucinating individuals who have the same disorder as the hallucinating individuals and are matched group-wise for severity of the disease, medication, age, sex, handedness and education.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
Healthy participants
Patients with schizophrenia
Patients with borderline personality disorder
Patients with hearing impairment
Patients with visual loss
Patients with Parkinson's Disease
Patients with Alzheimer's Disease
Patients with dementia with Lewy Bodies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Iris Sommer
• Investigators: Principal Investigator: Iris Sommer, Prof, Dr., UMC Utrecht

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: June 2, 2015
• First Posted (Estimate): June 3, 2015

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Hallucinations
• Other Study ID Numbers: UH-2