Neural Correlates of Neurofeedback Training

Not Applicable

• Conditions: Nicotine Dependence; PTSD; Depression

• Registration Number: NCT03165578
• Lead Sponsor: Frank Scharnowski

Brief Summary

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

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 Timeline

• Status Verified: 2017-05
• Study Start: 2017-05-01
• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-22
• Last Update Submitted: 2017-05-22
• Study First Posted: 2017-05-24
• Last Update Posted: 2017-05-24
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
brain patterns that mediate learning self-regulation in patients with fMRI neurofeedback	12 months	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.

Secondary Outcome Measures

Name	Time	Method
neurofeedback learning success	12 months	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.
behavioral consequences of neurofeedback training	12 months	Behavioral outcome measures (questionnaires, standard clinical assessments) will be compared between subjects in the experimental group vs. the sham control group.
maintenance of learned self-regulation	12 months	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.

Trial Locations

Locations (1)

Hospital of Psychiatry, University of Zurich; 🇨🇭 Zürich, Zürich-, Switzerland