Neural Correlates of Neurofeedback Training
Primary Purpose
Nicotine Dependence, Depression, PTSD
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Neurofeedback training
Sham Feedback
Sponsored by
About this trial
This is an interventional basic science trial for Nicotine Dependence
Eligibility Criteria
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).
Sites / Locations
- Hospital of Psychiatry, University of ZurichRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Neurofeedback
Sham Feedback
Arm Description
Neurofeedback training.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03165578
Brief Title
Neural Correlates of Neurofeedback Training
Official Title
Neural Correlates of Neurofeedback Training
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Frank Scharnowski
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Depression, PTSD
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neurofeedback
Arm Type
Experimental
Arm Description
Neurofeedback training.
Arm Title
Sham Feedback
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Neurofeedback training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
brain patterns that mediate learning self-regulation in patients with fMRI neurofeedback
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
neurofeedback learning success
Description
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.
Time Frame
12 months
Title
behavioral consequences of neurofeedback training
Description
Behavioral outcome measures (questionnaires, standard clinical assessments) will be compared between subjects in the experimental group vs. the sham control group.
Time Frame
12 months
Title
maintenance of learned self-regulation
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Scharnowski, Prof. Dr.
Phone
+41765682259
Email
Frank.Scharnowski@uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Scharnowski, Prof. Dr.
Organizational Affiliation
Hospital of Psychiatry, University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Psychiatry, University of Zurich
City
Zürich
State/Province
Zürich-
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Scharnowski, Prof. Dr.
Phone
+41443842953
Email
Frank.Scharnowski@uzh.ch
First Name & Middle Initial & Last Name & Degree
Ronald Sladky, PD Dr.
Phone
+41443842667
Email
ronald.sladky@uzh.ch
12. IPD Sharing Statement
Plan to Share IPD
No
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Neural Correlates of Neurofeedback Training
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