Hallucinations, Verbal AuditoryAPIC-IINCT02722915
Symptom Based Treatment Affects Brain Plasticity - the Role of Verbal Auditory Hallucinations
A study testing fMRI, Neurofeedback and PANAS in people with Hallucinations, Verbal Auditory, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hallucinations, Verbal Auditory
- What is being tested?
- fMRI, Neurofeedback and PANAS
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics
Aachen, 52074
About this study
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.
Read the 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.
- Conditions
- Hallucinations, Verbal Auditory
- Being tested
- fMRI, Neurofeedback, PANAS, AVHRS, SF36
- Keywords
- fMRI, neurofeedback, hallucination, schizophrenia
- Medical subject headings
- Hallucinations, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIProcedure or surgery
Also called functional magnetic resonance imaging
collection of functional brain data for 1 hour per day
NeurofeedbackBehavioural
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)
PANASOther
Also called Positive And Negative Affect Scales
to assess the mood before and after the fMRI and after 1 week during a telephone interview
AVHRSOther
Also called Auditory Vocal Hallucinations Rating Scale
to assess the intensity and quality of the hallucinations before and after the fMRI and after 1 week during a telephone interview
SF36Other
questionnaire about life quality after 1 week during a telephone interview
| Study group | Role | What they receive |
|---|---|---|
| fMRI Neurofeedback up-regulation | Experimental | Study related procedures included: PANAS, AVHRS, SF 36 (questionnaires or evaluations) Receives: 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) Receives: Procedure: fMRI; Behavioral: Neurofeedback; Other: PANAS; Other: AVHRS; Other: SF36 |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in self-control over neuronal connectivity
fMRI-BCI as a measure before and after the regulation of the brain activity
Measured: 1 week
Secondary outcomes (6)
Changes from baseline in brain plasticity
fMRI as a measure for brain plasticity before and after neurofeedback
Measured: 2 weeks
Change in pathology (AVH)
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
Measured: 1 week after interventions
number of patients and subjects with benefits from neurofeedback training
Measured: 2 weeks
change in brain activation
fMRI as a measure before and after the following resting state
Measured: 1 week after interventions
Change in pathology (mood)
Positive And Negative Affect Scales (PANAS) as a measure of mood before and after the fMRI and after 1 week during a telephone interview
Measured: 1 week after interventions
Change in perceived quality of life
SF36 questionnaire as a measure of the quality of life before and after the fMRI and after 1 week during a telephone interview
Measured: 1 week after interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallucinations, Verbal AuditoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klaus Mathiak, Prof MD PhD, Principal investigator, University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722915
- Sponsor's protocol ID
- 15-139
- Acronym
- APIC-II
- Status last verified
- Sep 2019
- First submitted
- 10 Mar 2016
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Based Treatment Affects Brain Plasticity - the Role of Verbal Auditory Hallucinations
- ClinicalTrials.gov ID
- NCT02722915
- Acronym / sponsor ID
- APIC-II / 15-139
- Conditions
- Hallucinations, Verbal Auditory
- Keywords
- fMRI, neurofeedback, hallucination, schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fMRI Neurofeedback up-regulation | Experimental | Procedure: fMRI, Behavioral: Neurofeedback, Other: PANAS, Other: AVHRS, Other: SF36Study related procedures included: PANAS, AVHRS, SF 36 (questionnaires or evaluations) |
| fMRI Neurofeedback down-regulation | Experimental | Procedure: fMRI, Behavioral: Neurofeedback, Other: PANAS, Other: AVHRS, Other: SF36Study related procedures included: PANAS, AVHRS, SF 36 (questionnaires or evaluations) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- addiction
- severe affective disorder
- any contraindication to MRI examination or claustrophobia
- pregnant or lactating women
- traumatic brain lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIAlso: functional magnetic resonance imagingcollection of functional brain data for 1 hour per day | Procedure or surgery | fMRI Neurofeedback down-regulation, fMRI Neurofeedback up-regulation |
| NeurofeedbackTask 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) | Behavioural | fMRI Neurofeedback down-regulation, fMRI Neurofeedback up-regulation |
| PANASAlso: Positive And Negative Affect Scalesto assess the mood before and after the fMRI and after 1 week during a telephone interview | Other | fMRI Neurofeedback down-regulation, fMRI Neurofeedback up-regulation |
| AVHRSAlso: Auditory Vocal Hallucinations Rating Scaleto assess the intensity and quality of the hallucinations before and after the fMRI and after 1 week during a telephone interview | Other | fMRI Neurofeedback down-regulation, fMRI Neurofeedback up-regulation |
| SF36questionnaire about life quality after 1 week during a telephone interview | Other | fMRI Neurofeedback down-regulation, fMRI Neurofeedback up-regulation |
Primary outcome
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
6 secondary outcomes
Changes from baseline in brain plasticity
Time frame: 2 weeks
Change in pathology (AVH)
Time frame: 1 week after interventions
number of patients and subjects with benefits from neurofeedback training
Time frame: 2 weeks
change in brain activation
Time frame: 1 week after interventions
Change in pathology (mood)
Time frame: 1 week after interventions
Change in perceived quality of life
Time frame: 1 week after interventions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Mathiak, Prof MD PhD principal investigator
University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI, Neurofeedback and PANAS in people with Hallucinations, Verbal Auditory, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in self-control over neuronal connectivity (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.