Understanding Hallucinations (Part II)

NCT02460965 | Unknown DMC

• 1 other identifier: UH-2
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallucinations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Other Outcomes (1)

• Cardio-respiratory rhythms to correct for cardio-respiratory processes in the fMRI signal.

  Three years

Study Arms (8)

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

Healthy participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Iris Sommer: lead

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Hallucinations

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Iris Sommer, Prof, Dr.

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanne Koops, Msc.

CONTACT

+31887558672; S.Koops@umcutrecht.nl

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: June 3, 2015
• Study Start: November 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

NL (1)