Symptom Based Treatment Affects Brain Plasticity - Cognitive Training in Patients With Affective Symptoms

NCT03183947 | Completed

• 1 other identifier: 17-094
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is the examination of brain plasticity on on affective symptoms after neuromodulation with fMRI (functional magnetic resonance imaging) neurofeedback. During the fMRI neurofeedback training, patients with depression as well as patients with schizophrenia are trained to consciously regulate the activity of areas which are associated with the cognitive reappraisal of emotional stimuli.The aim is to improve the patients' subjective emotional processing and perception in everyday life as well as to investigate the impact of neurofeedback on resting-state networks in the brain. Healthy participants will be investigated as control group.

Conditions

Depression; Schizophrenia

Keywords

fMRI; neurofeedback; emotion regulation; schizophrenia; cognitive reappraisal; depression

Outcome Measures

Primary Outcomes (1)

• change in self-control over neuronal activity in PFC

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

  1 week

Secondary Outcomes (5)

• Changes from baseline in brain plasticity

  2 weeks

• Change in pathology (depression)

  4 weeks after interventions

• specificity of left or right PFC neurofeedback

  2 weeks

• change in resting state brain activation

  2 weeks

• Change in pathology (mood)

  4 weeks after interventions

Study Arms (2)

fMRI Neurofeedback regulation of left PFC

EXPERIMENTAL

Study related procedures included: PANAS, BDI-II, ERQ (questionnaires or evaluations)

Procedure: fMRI; Behavioral: Neurofeedback; Other: PANAS; Other: BDI-II; Other: ERQ

fMRI Neurofeedback of right PFC

EXPERIMENTAL

Study related procedures included: PANAS, BDI-II, ERQ (questionnaires or evaluations)

Procedure: fMRI; Behavioral: Neurofeedback; Other: PANAS; Other: BDI-II; Other: ERQ

Interventions

fMRI PROCEDURE

collection of functional brain data for 1 hour per day

Also known as: functional magnetic resonance imaging

fMRI Neurofeedback of right PFC; fMRI Neurofeedback regulation of left PFC

Neurofeedback BEHAVIORAL

Task of the participants is to increase the activity in the selected brain region (left or right prefrontal cortex). After regulation they will get a feedback about the regulation success. (Patients: days 3 \& 4; controls: Days 2 \& 3)

fMRI Neurofeedback of right PFC; fMRI Neurofeedback regulation of left PFC

PANAS OTHER

to assess the mood before and after the fMRI and after 4 weeks during a telephone interview

Also known as: Positive And Negative Affect Scales

fMRI Neurofeedback of right PFC; fMRI Neurofeedback regulation of left PFC

BDI-II OTHER

to assess depressive symptomatology before neurofeedback and 4 weeks after the intervention during telephone interview

Also known as: Beck's depression inventory

fMRI Neurofeedback of right PFC; fMRI Neurofeedback regulation of left PFC

ERQ OTHER

To assess emotion regulation strategies before and after neurofeedback training (patients: day 3\&4; controls: day 2\&3) and after 4 weeks during a telephone interview

Also known as: Emotion regulation questionnaire

fMRI Neurofeedback of right PFC; fMRI Neurofeedback regulation of left PFC

Eligibility Criteria

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

You may qualify if:

• Depression according to ICD-10 (F32.x, F33.x, F31.3 or F34.x); Schizophrenia according to ICD-10 (F2x); or healthy subjects
• Fluent German language skills

You may not qualify if:

• any contraindication to MRI examination or claustrophobia
• pregnant or lactating women
• acute suicidal tendency
• persons incapable of giving consent

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

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

Aachen, 52074, Germany

Location

Related Publications (9)

• Buhle JT, Silvers JA, Wager TD, Lopez R, Onyemekwu C, Kober H, Weber J, Ochsner KN. Cognitive reappraisal of emotion: a meta-analysis of human neuroimaging studies. Cereb Cortex. 2014 Nov;24(11):2981-90. doi: 10.1093/cercor/bht154. Epub 2013 Jun 13.

  PMID: 23765157 BACKGROUND

• Hayes JP, Vanelzakker MB, Shin LM. Emotion and cognition interactions in PTSD: a review of neurocognitive and neuroimaging studies. Front Integr Neurosci. 2012 Oct 9;6:89. doi: 10.3389/fnint.2012.00089. eCollection 2012.

  PMID: 23087624 BACKGROUND

• Kohn N, Eickhoff SB, Scheller M, Laird AR, Fox PT, Habel U. Neural network of cognitive emotion regulation--an ALE meta-analysis and MACM analysis. Neuroimage. 2014 Feb 15;87:345-55. doi: 10.1016/j.neuroimage.2013.11.001. Epub 2013 Nov 9.

  PMID: 24220041 BACKGROUND

• Linden DE, Habes I, Johnston SJ, Linden S, Tatineni R, Subramanian L, Sorger B, Healy D, Goebel R. Real-time self-regulation of emotion networks in patients with depression. PLoS One. 2012;7(6):e38115. doi: 10.1371/journal.pone.0038115. Epub 2012 Jun 4.

  PMID: 22675513 BACKGROUND

• Ochsner KN, Bunge SA, Gross JJ, Gabrieli JD. Rethinking feelings: an FMRI study of the cognitive regulation of emotion. J Cogn Neurosci. 2002 Nov 15;14(8):1215-29. doi: 10.1162/089892902760807212.

  PMID: 12495527 BACKGROUND

• Weiskopf N, Scharnowski F, Veit R, Goebel R, Birbaumer N, Mathiak K. Self-regulation of local brain activity using real-time functional magnetic resonance imaging (fMRI). J Physiol Paris. 2004 Jul-Nov;98(4-6):357-73. doi: 10.1016/j.jphysparis.2005.09.019. Epub 2005 Nov 10.

  PMID: 16289548 BACKGROUND

• Joormann J, Gotlib IH. Emotion regulation in depression: relation to cognitive inhibition. Cogn Emot. 2010 Feb 1;24(2):281-98. doi: 10.1080/02699930903407948.

  PMID: 20300538 BACKGROUND

• Troy AS, Wilhelm FH, Shallcross AJ, Mauss IB. Seeing the silver lining: cognitive reappraisal ability moderates the relationship between stress and depressive symptoms. Emotion. 2010 Dec;10(6):783-95. doi: 10.1037/a0020262.

  PMID: 21058843 BACKGROUND

• Keller M, Zweerings J, Klasen M, Zvyagintsev M, Iglesias J, Mendoza Quinones R, Mathiak K. fMRI Neurofeedback-Enhanced Cognitive Reappraisal Training in Depression: A Double-Blind Comparison of Left and Right vlPFC Regulation. Front Psychiatry. 2021 Aug 23;12:715898. doi: 10.3389/fpsyt.2021.715898. eCollection 2021.

  PMID: 34497546 DERIVED

MeSH Terms

Conditions

Depression; Schizophrenia; Emotional Regulation

Interventions

Neurofeedback; Gene Expression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Self-Control; Social Behavior

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: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 12, 2017
• Study Start: August 29, 2017
• Primary Completion: December 6, 2019
• Study Completion: December 6, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Locations

DE (1)