- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01390493
Therapeutic Effects of Neurofeedback in Anorexia Nervosa
Therapeutic Effects of Alpha-neurofeedback in the Treatment of Anorexia Nervosa
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- anorexia nervosa diagnosed by ICD-10
Exclusion Criteria:
- epilepsy or other brain organic diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: neurofeedback, alpha power
|
training of individual alpha frequency, 10 sessions, each 15 min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
brain activity in the alpha band
Time Frame: 10 sessions neurofeedback
|
measuring selected variables pre/posttraining and follow-up and on 10 points of measurement (10 sessions neurofeedback)
|
10 sessions neurofeedback
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nina Lackner, Mag., Department of Psychology, Karl-Franzens-University Graz
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEUROAN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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