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Trial record 10 of 155 for:    neurofeedback

Neural Correlates of Neurofeedback Training

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ClinicalTrials.gov Identifier: NCT03165578
Recruitment Status : Recruiting
First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Frank Scharnowski, Psychiatric University Hospital, Zurich

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Depression PTSD Other: Neurofeedback training Other: Sham Feedback Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Neural Correlates of Neurofeedback Training
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. brain patterns that mediate learning self-regulation in patients with fMRI neurofeedback [ Time Frame: 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 :
  1. neurofeedback learning success [ Time Frame: 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.

  2. behavioral consequences of neurofeedback training [ Time Frame: 12 months ]
    Behavioral outcome measures (questionnaires, standard clinical assessments) will be compared between subjects in the experimental group vs. the sham control group.

  3. maintenance of learned self-regulation [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165578


Contacts
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Contact: Frank Scharnowski, Prof. Dr. +41765682259 Frank.Scharnowski@uzh.ch

Locations
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Switzerland
Hospital of Psychiatry, University of Zurich Recruiting
Zürich, Zürich-, Switzerland, 8032
Contact: Frank Scharnowski, Prof. Dr.    +41443842953    Frank.Scharnowski@uzh.ch   
Contact: Ronald Sladky, PD Dr.    +41443842667    ronald.sladky@uzh.ch   
Sponsors and Collaborators
Frank Scharnowski
Investigators
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Principal Investigator: Frank Scharnowski, Prof. Dr. Hospital of Psychiatry, University of Zurich

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Responsible Party: Frank Scharnowski, Prof. Dr., Psychiatric University Hospital, Zurich
ClinicalTrials.gov Identifier: NCT03165578     History of Changes
Other Study ID Numbers: PsychiatricUHZ
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders