An interventional study of Real-time fMRI feedback and Treatment as usual in Aggression and Conduct Disorder, sponsored by Central Institute of Mental Health, Mannheim. Completed at 1 site in Germany. Open to participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-02.
Sponsored by Central Institute of Mental Health, Mannheim · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether real-time fMRI feedback is effective in the treatment of aggressive behavior problems in adolescents with high callous unemotional traits when compared to treatment as usual.
In this study, which is part of the European research project MATRICS (Multidisciplinary Approaches to Translational Research), the investigators focus on testing an innovative, non-pharmacological therapeutic approach for adolescents with a specific, difficult to treat subtype of aggressive behavior problems. Participants will be trained to acquire control over their own physiological parameters, in case of this study the activation of certain brain areas. While trying to control these parameters, participants get direct continuous feedback about their physiological state and its changes, and are rewarded for successful manipulation. Biofeedback methods are currently used to treat patients with a variety of psychiatric disorders such as attention-deficit/hyperactivity disorder (ADHD).
Here, real-time functional magnetic resonance imaging (rt-fMRI) feedback will be used, where participants will get feedback about activation levels and patterns from brain regions associated with emotion processing (amygdala/insula) in almost real time while lying in a magnetic resonance tomograph scanner.
Investigators will focus on the following questions concerning the effectiveness of this treatment approach:
Before the training, all participants will undergo an extensive pre-treatment assessment as part of the characterization and subtyping of aggression within the large multicenter subtyping studies (EU-Aggressotype and EU-MATRICS). The assessment includes clinical and psychometric measures, neuropsychological testing, fMRI (3 active tasks + resting state), MRS (anterior cingulate cortex (ACC) and insula) and diffusion tensor imaging (DTI) as well as biosampling (blood/saliva for genetics/epigenetics/hormones). Comparison with a typically developing (TD) control group receiving no intervention will allow to interpret changes in terms of normalization or compensation.
After completion of this pretest, subjects meeting the inclusion criteria for the rt-fMRI treatment study will be randomly assigned to two different treatment arms, either to the experimental fMRI real-time feedback condition or to the comparator condition with treatment as usual (TAU) lasting 10 weeks. Subjects assigned to the experimental condition will receive 10 sessions (1/week) of real-time fMRI feedback of amygdala and/or insula activation (based on activation patterns during pre-training assessment). Each training will last about 1 1/2 hours and consist of 3 experimental blocks, including feedback- and transfer trials. Video clips of emotional and aggressive interpersonal interactions will partly be used to enrich feedback conditions with naturalistic, virtual reality type displays. Heart rate and electrodermal activity will be recorded simultaneously during the sessions. Subjects in the comparator TAU arm will receive several sessions of psychoeducation and counseling with their parents/caregivers or group training over the 10 weeks.
After completion of either the training or the TAU, subjects will undergo post-treatment assessment, repeating the teachers and parents reports on behavioral measures, as well as the neuropsychological testing, fMRI and MRS. A follow-up assessment will take place 6 months after the end of the treatment phase and will comprise only parents and teachers reports on behavioral measures.
248 studies on the registry are indexed under Aggression; 41 are open to participants now.
This study's enrollment of 37 is below the median of 80 across 221 interventional studies indexed under Aggression.
Browse Aggression studies →Central Institute of Mental Health, Mannheim is the lead sponsor of 60 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria (typically developing (TD) group):
Exclusion Criteria (both groups):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After a pre-training assessment at baseline, subjects will be randomized to either treatment arm or treatment as usual. Subjects in the experimental condition will receive 10 sessions of real-time fMRI feedback of insula- or amygdala activation (dependent on activation patterns during pre-testing), 1 session/week. Each session will last about 1 1/2 hours. After training completion (10 weeks after the beginning of the treatment phase), subjects will undergo post-treatment assessment and follow up (6 months after the end of the training phase).
Behavioral: Real-time fMRI feedback
After a pre-training assessment at baseline, subjects will be randomized to either treatment arm or treatment as usual. Subjects in the comparator TAU arm will receive several sessions of psychoeducation and counseling with their parents/caregivers or group training over 10 weeks. Within the sessions, investigators will focus on psychoeducational issues and provide general counseling for the families. After 10 weeks, subjects will undergo post-treatment assessment and follow up (6 months after the end of the treatment phase).
Behavioral: Treatment as usual
Healthy typically developing subjects will only participate in pre-training assessment to allow for comparison.
feedback about activation patterns in brain regions related with instrumental aggression
Psychoeducation, general counselling
Changes in aggressive behavior from baseline at 10 weeks and 6 months as assessed by the Modified Overt Aggression Scale (MOAS)
Parents or caregivers report on type and intensity of aggressive behavior over the last weeks (questionnaire)
Time frame: Baseline, post treatment assessment (10 weeks after beginning of the treatment phase) and follow up (6 months after end of the treatment)
Changes in brain activation from baseline at 10 weeks after the beginning of the treatment phase as assessed by fMRI
At baseline and at the end of the treatment phase, patients will perform 3 functional tasks in the fMRI. The tasks used are: Stop-Signal Task, Emotional Faces task, Passive Avoidance task.
Time frame: Baseline and post treatment assessment (10 weeks after the beginning of the treatment phase)
Changes in composition of neurotransmitter systems from baseline at 10 weeks after the beginning of the treatment phase as assessed by MRS
At baseline and at the end of the treatment phase, patients will undergo magnetic resonance spectroscopy (MRS) of two brain areas implicated in inhibitory control (ACC and insula)
Time frame: Baseline and post treatment assessment (10 weeks after the beginning of the treatment phase)
Changes in aggressive behavior from baseline at 10 weeks and at 6 months as reported by teachers through the aggressive behavior subscale of the TRF (Teachers Report Form)
At baseline, after the end of the treatment phase (10 weeks) and at follow up (6 months), teachers will be asked to complete the TRF, which is a questionnaire focusing on general psychopathology ( and allows to differentiate between several subsets of symptoms, amongst others those indicating externalizing and aggressive behavior)
Time frame: Baseline, post treatment assessment (10 weeks after beginning of the treatment phase) and follow up (6 months after end of the treatment)
The record gives a start of Oct 2015, a primary completion of Jul 2019 and a completion of Jul 2019. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Central Institute of Mental Health, Mannheim