Neural Correlates of Neurofeedback Training

The objective of the present study is to identify brain networks in patients that contribute to successfully learning self-regulation with real-time fMRI.

Study Overview

• Status: Unknown
• Conditions: Depression; PTSD; Nicotine Dependence
• Intervention / Treatment: Other: Neurofeedback training; Other: Sham Feedback

Detailed Description

Neurofeedback has been established as a promising non-pharmacological therapeutic approach. However, patients differ in their ability to learn control over their own brain activity with neurofeedback. It is thus crucial to understand the brain networks that mediate learned self-regulation with real-time fMRI. The objective of the present study is thus to identify brain networks in patients that contribute to successfully learning self-regulation with real-time fMRI. To achieve this goal, patients suffering from depression, post-traumatic stress disorder, and nicotine addiction will be trained to improve their self-regulation skills using established real-time fMRI neurofeedback protocols.

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frank Scharnowski, Prof. Dr.; Phone Number: +41765682259; Email: Frank.Scharnowski@uzh.ch

Study Locations

• Switzerland
  • Zürich-
    • Zürich, Zürich-, Switzerland, 8032
      • Recruiting
      • Hospital of Psychiatry, University of Zurich
      • Contact: Frank Scharnowski, Prof. Dr.; Phone Number: +41443842953; Email: Frank.Scharnowski@uzh.ch
      • Contact: Ronald Sladky, PD Dr.; Phone Number: +41443842667; Email: ronald.sladky@uzh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Magnetic resonance imaging compatibility.
• DSM-V diagnosis of major depressive disorder, post-traumatic stress disorder, or nicotine addiction, respectively.

Exclusion Criteria:

• Other physical or psychiatric disorders.
• Current substance abuse.
• Exclusion criteria applicable to MRI (metallic implants, claustrophobia, epilepsy).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neurofeedback; Neurofeedback training.	Other: Neurofeedback training; In a neurofeedback setting, brain activity is measured non-invasively, the brain imaging data is analyzed in real-time, and then feedback regarding the current level of brain activity is provided to the subject.
Sham Comparator: Sham Feedback; Sham controlled neurofeedback training. Subjects in the sham control group will undergo the same procedure as subjects in the experimental group, but instead of being shown feedback derived from their own brain activity, they will be shown replayed feedback values from a randomly chosen subject of the experimental group.	Other: Sham Feedback; Sham controlled neurofeedback training. Subjects in the sham control group will undergo the same procedure as subjects in the experimental group, but instead of being shown feedback derived from their own brain activity, they will be shown replayed feedback values from a randomly chosen subject of the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
brain patterns that mediate learning self-regulation in patients with fMRI neurofeedback	Functional MRI data will be analysed using a whole brain mixed effect analysis across all subjects that compares brain patterns during self-regulation and baseline.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurofeedback learning success	Increased self-regulation skills will be assessed by a comparison of the slopes of the neurofeedback learning curves between subjects in the experimental group vs. the sham control group.	12 months
behavioral consequences of neurofeedback training	Behavioral outcome measures (questionnaires, standard clinical assessments) will be compared between subjects in the experimental group vs. the sham control group.	12 months
maintenance of learned self-regulation	An assessment of learned self-regulation (i.e. increase of the feedback signal in up-regulation compared to baseline blocks) in follow-up scanning sessions that will take place 6 months and 1 year after neurofeedback training. This will be a measure of how well learned self-regulation can be maintained.	12 months

Collaborators and Investigators

• Sponsor: Frank Scharnowski
• Investigators: Principal Investigator: Frank Scharnowski, Prof. Dr., Hospital of Psychiatry, University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 24, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: PsychiatricUHZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No