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
About this trial
This is an interventional treatment trial for Anorexia Nervosa focused on measuring neurofeedback, alpha, anorexia nervosa
Eligibility Criteria
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
NCT ID
NCT01390493
First Posted
July 7, 2011
Last Updated
March 10, 2015
Sponsor
Medical University of Graz
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
We'll reach out to this number within 24 hrs