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Therapeutic Effects of Neurofeedback in Anorexia Nervosa

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
neurofeedback training
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring neurofeedback, alpha, anorexia nervosa

Eligibility Criteria

12 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • anorexia nervosa diagnosed by ICD-10

Exclusion Criteria:

  • epilepsy or other brain organic diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    neurofeedback, alpha power

    Arm Description

    Outcomes

    Primary Outcome Measures

    brain activity in the alpha band
    measuring selected variables pre/posttraining and follow-up and on 10 points of measurement (10 sessions neurofeedback)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 7, 2011
    Last Updated
    March 10, 2015
    Sponsor
    Medical University of Graz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01390493
    Brief Title
    Therapeutic Effects of Neurofeedback in Anorexia Nervosa
    Official Title
    Therapeutic Effects of Alpha-neurofeedback in the Treatment of Anorexia Nervosa
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2010 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of Graz

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether neurofeedback training can significantly reduce the symptoms of anorexia nervosa (AN) with focus on changes in personality and psychological well-being. The primary aims of this study include: To examine whether AN patients are able to control their alpha-activity through neurofeedback. To examine the effects of neurofeedback on symptomatology and personality variables in AN patients. To examine the long-term effects of neurofeedback in the treatment of AN.
    Detailed Description
    The aim of the present study is to investigate the impact of EEG frequency band biofeedback (neurofeedback) training on EEG topography and symptomatology of patients suffering from anorexia nervosa (AN). There is evidence that alpha-neurofeedback leads to an increase in positive therapy outcome in clinical populations by changing long-lasting EEG frequency patterns. The use of an EEG-guided relaxation paradigm has been shown to be associated with well-being and improvements in pathology of psychiatric patients. In the present study the effects of alpha-training on EEG activity, mood, personality, well-being, blood parameters, and heart frequency will be evaluated in a sample of anorectic girls (12-18 years). The subjects are trained with at least 10 sessions alpha-neurofeedback, in order to enhance individual alpha frequency, with spectral resting EEG, EKG, blood samples, ERP-measures and psychometric measures assessed before and after training. Neurofeedback is conducted over a period of five weeks, with each participant receiving two training sessions per-week. Neurofeedback is administered using USBAmp-EEG system. For better surveillance of training effects there are two non-treatment control groups. A patient group receiving conventional therapy programme of the Psychosomatic Division of the Pediatric Department at the University Hospital Graz and a healthy control group. A twelve-week follow-up study is carried out in order to document long-term effects of alpha-neurofeedback training in AN patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anorexia Nervosa
    Keywords
    neurofeedback, alpha, anorexia nervosa

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    neurofeedback, alpha power
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    neurofeedback training
    Intervention Description
    training of individual alpha frequency, 10 sessions, each 15 min
    Primary Outcome Measure Information:
    Title
    brain activity in the alpha band
    Description
    measuring selected variables pre/posttraining and follow-up and on 10 points of measurement (10 sessions neurofeedback)
    Time Frame
    10 sessions neurofeedback

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: anorexia nervosa diagnosed by ICD-10 Exclusion Criteria: epilepsy or other brain organic diseases
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nina Lackner, Mag.
    Organizational Affiliation
    Department of Psychology, Karl-Franzens-University Graz
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Therapeutic Effects of Neurofeedback in Anorexia Nervosa

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