Neural Correlates of Neurofeedback Training

Depression Clinical Trial

Official title:

Neural Correlates of Neurofeedback Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03165578
• Other study ID #: PsychiatricUHZ
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2017
• Last updated: May 22, 2017
• Start date: May 1, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: May 2017
• Source: Psychiatric University Hospital, Zurich
• Contact: Frank Scharnowski, Prof. Dr.
• Phone: +41765682259
• Email: Frank.Scharnowski[@]uzh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Nicotine Dependence
• PTSD
• Tobacco Use Disorder

Intervention

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 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.

Locations

Country	Name	City	State
Switzerland	Hospital of Psychiatry, University of Zurich	Zürich	Zürich-

Sponsors (1)

Lead Sponsor	Collaborator
Frank Scharnowski

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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