Neural Correlates of Neurofeedback Training

NCT ID: NCT03165578

Last Updated: 2017-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Nicotine Dependence Depression PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Neurofeedback

Neurofeedback training.

Group Type EXPERIMENTAL

Neurofeedback training

Intervention Type OTHER

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.

Group Type SHAM_COMPARATOR

Sham Feedback

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frank Scharnowski

OTHER

Sponsor Role lead

Responsible Party

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Frank Scharnowski

Prof. Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Frank Scharnowski, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital of Psychiatry, University of Zurich

Locations

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Hospital of Psychiatry, University of Zurich

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Frank Scharnowski, Prof. Dr.

Role: CONTACT

+41765682259

Facility Contacts

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Frank Scharnowski, Prof. Dr.

Role: primary

+41443842953

Ronald Sladky, PD Dr.

Role: backup

+41443842667

Other Identifiers

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PsychiatricUHZ

Identifier Type: -

Identifier Source: org_study_id

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