Skip to main content
OpenTrials
Completed

NCT Number: NCT02722915

Symptom Based Treatment Affects Brain Plasticity - the Role of Verbal Auditory Hallucinations

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics

Aachen, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fMRI

Procedure

collection of functional brain data for 1 hour per day

Other names: functional magnetic resonance imaging

Neurofeedback

Behavioral

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)

PANAS

Other

to assess the mood before and after the fMRI and after 1 week during a telephone interview

Other names: Positive And Negative Affect Scales

AVHRS

Other

to assess the intensity and quality of the hallucinations before and after the fMRI and after 1 week during a telephone interview

Other names: Auditory Vocal Hallucinations Rating Scale

SF36

Other

questionnaire about life quality after 1 week during a telephone interview

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Acronym: APIC-II

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 30, 2016
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.