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

NCT02722915 | Completed

• 1 other identifier: 15-139
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallucinations, Verbal Auditory

Keywords

fMRI; neurofeedback; hallucination; schizophrenia

Outcome Measures

Primary Outcomes (1)

• change in self-control over neuronal connectivity

  fMRI-BCI as a measure before and after the regulation of the brain activity

  1 week

Secondary Outcomes (6)

• Changes from baseline in brain plasticity

  2 weeks

• Change in pathology (AVH)

  1 week after interventions

• number of patients and subjects with benefits from neurofeedback training

  2 weeks

• change in brain activation

  1 week after interventions

• Change in pathology (mood)

  1 week after interventions

Study Arms (2)

fMRI Neurofeedback up-regulation

EXPERIMENTAL

Study related procedures included: PANAS, AVHRS, SF 36 (questionnaires or evaluations)

Procedure: fMRI; Behavioral: Neurofeedback; Other: PANAS; Other: AVHRS; Other: SF36

fMRI Neurofeedback down-regulation

EXPERIMENTAL

Study related procedures included: PANAS, AVHRS, SF 36 (questionnaires or evaluations)

Procedure: fMRI; Behavioral: Neurofeedback; Other: PANAS; Other: AVHRS; Other: SF36

Interventions

fMRI PROCEDURE

collection of functional brain data for 1 hour per day

Also known as: functional magnetic resonance imaging

fMRI Neurofeedback down-regulation; fMRI Neurofeedback up-regulation

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)

fMRI Neurofeedback down-regulation; fMRI Neurofeedback up-regulation

PANAS OTHER

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

Also known as: Positive And Negative Affect Scales

fMRI Neurofeedback down-regulation; fMRI Neurofeedback up-regulation

AVHRS OTHER

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

Also known as: Auditory Vocal Hallucinations Rating Scale

fMRI Neurofeedback down-regulation; fMRI Neurofeedback up-regulation

SF36 OTHER

questionnaire about life quality after 1 week during a telephone interview

fMRI Neurofeedback down-regulation; fMRI Neurofeedback up-regulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

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

Aachen, 52074, Germany

Location

MeSH Terms

Conditions

Hallucinations; Schizophrenia

Interventions

Neurofeedback; Gene Expression

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Genetic Phenomena

Study Officials

• Klaus Mathiak, Prof MD PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 30, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 9, 2020

Record last verified: 2019-09

Locations

DE (1)