Neural Correlates of Neurofeedback Training
1 other identifier
interventional
210
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 19, 2017
CompletedFirst Posted
Study publicly available on registry
May 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedMay 24, 2017
May 1, 2017
3.4 years
May 19, 2017
May 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
neurofeedback learning success
12 months
behavioral consequences of neurofeedback training
12 months
maintenance of learned self-regulation
12 months
Study Arms (2)
Neurofeedback
EXPERIMENTALNeurofeedback training.
Sham Feedback
SHAM COMPARATORSham 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Magnetic resonance imaging compatibility.
- DSM-V diagnosis of major depressive disorder, post-traumatic stress disorder, or nicotine addiction, respectively.
You may not qualify if:
- Other physical or psychiatric disorders.
- Current substance abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of Psychiatry, University of Zurich
Zurich, Canton of Zurich, 8032, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Scharnowski, Prof. Dr.
Hospital of Psychiatry, University of Zurich
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
May 19, 2017
First Posted
May 24, 2017
Study Start
May 1, 2017
Primary Completion
September 30, 2020
Study Completion
September 30, 2020
Last Updated
May 24, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share