Clinical Trial: Understanding Hallucinations (Part II)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Understanding Hallucinations (Part II) - fMRI and EEG

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 e

Detailed Summary:
Sponsor: Iris Sommer

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The difference in EEG correlates between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes. [ Time Frame: Three years ]
    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.
  • The auditory and visual cortex responsiveness patterns between hallucinating individuals of different subtypes. [ Time Frame: Three years ]
    The frequency of spontaneous synchronized burst activations in auditory and visual cortices


Original Secondary Outcome: Same as current

Information By: UMC Utrecht

Dates:
Date Received: February 24, 2014
Date Started: November 2013
Date Completion: March 2017
Last Updated: October 25, 2016
Last Verified: October 2016