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Symptom Based Treatment Affects Brain Plasticity - the Role of Verbal Auditory Hallucinations (APIC-II)

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ClinicalTrials.gov Identifier: NCT02722915
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:
The aim of the study is the examination of brain plasticity on verbal auditory hallucinations (AVH) after neuromodulation with fMRI (functional magnetic resonance imaging) neurofeedback. During the training of fMRI neurofeedback subjects are trained to regulate consciously the connectivity of areas which are associated with hallucinations.The aim is to improve perceived hallucinations' intensity in everyday life of the patients as well as investigating the impact of neurofeedback on resting-state networks in the brain. As control groups, control subjects without AVH and participants with AVH, but no psychiatric diagnosis will be included.

Condition or disease Intervention/treatment Phase
Hallucinations, Verbal Auditory Procedure: fMRI Behavioral: Neurofeedback Other: PANAS Other: AVHRS Other: SF36 Not Applicable

Detailed Description:

This study investigates the brain plasticity after neuromodulation with fMRI neurofeedback on verbal auditory hallucinations (AVH). The new technique of real-time fMRI enables subjects to influence their brain activity in certain areas based on neurofeedback. Current brain activity as measured by fMRI will be reported to the participants in real time via brain computer interface (BCI). Due to the identification of contingency between feedback and mental strategies subjects are able to control their own brain activity consciously. This provides the opportunity to control symptoms such as AVH. Neurofeedback has been tested on subjects with schizophrenia, leading to conscious control of circumscribed brain areas. Recent studies show that, in addition to the modulation of single areas, neurofeedback can also modulate connectivity between different areas. Thus, it is possible to regulate not only single brain regions but also whole networks.

AVH are a key symptom of schizophrenia. They limit social functions significantly and are resistant to the therapy with antipsychotics in 25 % of cases. AVH also occur in 6-15 % of the healthy population, without meeting any diagnostic criteria for schizophrenia or other psychiatric disorders. This study will perform a direct, not-invasive and selective modulation of networks underlying AVH and assess their neural, cognitive and emotional effects. The focus of this study is on the connectivity between auditory cortex and inferior frontal cortex. Various studies demonstrated that the auditory cortex exhibits an abnormal function in schizophrenia patients. It was shown that during AVH, auditory cortex (superior temporal lobe) and inferior frontal cortex synchronize spontaneously. These regions play an essential role in speech perception and processing. An increased synchronisation of these areas could lead to the development of AVH. This study will try to reduce frontotemporal connectivity to uncouple the regions. Increasing connectivity of both areas will serve as control condition and furthermore intensify the perceived control of the own brain activity and of the associated AVH. Thus, patients will learn which factors influence the appearance of their hallucinations.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : July 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: fMRI Neurofeedback up-regulation
Study related procedures included: PANAS, AVHRS, SF 36 (questionnaires or evaluations)
Procedure: fMRI
collection of functional brain data for 1 hour per day
Other Name: functional magnetic resonance imaging

Behavioral: Neurofeedback
Task of the participants is to increase or decrease the connectivity between selected brain regions in double-blind, randomized order. After the regulation they will get a feedback about the regulation success. (Patients and controls with AVH: days 3 & 4; controls without AVH: Days 2 & 3)

Other: PANAS
to assess the mood before and after the fMRI and after 1 week during a telephone interview
Other Name: Positive And Negative Affect Scales

Other: AVHRS
to assess the intensity and quality of the hallucinations before and after the fMRI and after 1 week during a telephone interview
Other Name: Auditory Vocal Hallucinations Rating Scale

Other: SF36
questionnaire about life quality after 1 week during a telephone interview

Experimental: fMRI Neurofeedback down-regulation
Study related procedures included: PANAS, AVHRS, SF 36 (questionnaires or evaluations)
Procedure: fMRI
collection of functional brain data for 1 hour per day
Other Name: functional magnetic resonance imaging

Behavioral: Neurofeedback
Task of the participants is to increase or decrease the connectivity between selected brain regions in double-blind, randomized order. After the regulation they will get a feedback about the regulation success. (Patients and controls with AVH: days 3 & 4; controls without AVH: Days 2 & 3)

Other: PANAS
to assess the mood before and after the fMRI and after 1 week during a telephone interview
Other Name: Positive And Negative Affect Scales

Other: AVHRS
to assess the intensity and quality of the hallucinations before and after the fMRI and after 1 week during a telephone interview
Other Name: Auditory Vocal Hallucinations Rating Scale

Other: SF36
questionnaire about life quality after 1 week during a telephone interview




Primary Outcome Measures :
  1. change in self-control over neuronal connectivity [ Time Frame: 1 week ]
    fMRI-BCI as a measure before and after the regulation of the brain activity


Secondary Outcome Measures :
  1. Changes from baseline in brain plasticity [ Time Frame: 2 weeks ]
    fMRI as a measure for brain plasticity before and after neurofeedback

  2. Change in pathology (AVH) [ Time Frame: 1 week after interventions ]
    Auditory Vocal Hallucinations Rating Scale (AVHRS) as a measure of the intensity and quality of the hallucinations before and after the fMRI and after 1 week during a telephone interview

  3. number of patients and subjects with benefits from neurofeedback training [ Time Frame: 2 weeks ]
  4. change in brain activation [ Time Frame: 1 week after interventions ]
    fMRI as a measure before and after the following resting state

  5. Change in pathology (mood) [ Time Frame: 1 week after interventions ]
    Positive And Negative Affect Scales (PANAS) as a measure of mood before and after the fMRI and after 1 week during a telephone interview

  6. Change in perceived quality of life [ Time Frame: 1 week after interventions ]
    SF36 questionnaire as a measure of the quality of life before and after the fMRI and after 1 week during a telephone interview



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Schizophrenia according to ICD-10 (F2x) with verbal hallucinations or only verbal hallucinations (no psychiatric diagnosis) or healthy subjects without verbal hallucinations
  • Fluent German language skills

Exclusion Criteria:

  • addiction
  • severe affective disorder
  • any contraindication to MRI examination or claustrophobia
  • pregnant or lactating women
  • traumatic brain lesions
  • acute physical or neurological impairments
  • acute suicidal tendency
  • Lack of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722915


Contacts
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Contact: Klaus Mathiak, Prof MD PhD +49 241 80-89647 kmathiak@ukaachen.de
Contact: Martin Klasen, Dr rer medic +49 241 80-85580 mklasen@ukaachen.de

Locations
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Germany
University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics Recruiting
Aachen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Klaus Mathiak, Prof MD PhD University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02722915     History of Changes
Other Study ID Numbers: 15-139
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by RWTH Aachen University:
fMRI
neurofeedback
hallucination
schizophrenia

Additional relevant MeSH terms:
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Hallucinations
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms