Therapeutic Effects of Neurofeedback in Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

Therapeutic Effects of Alpha-neurofeedback in the Treatment of Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390493
• Other study ID #: NEUROAN
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 7, 2011
• Last updated: March 10, 2015
• Start date: October 2010
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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:

1. To examine whether AN patients are able to control their alpha-activity through neurofeedback.

2. To examine the effects of neurofeedback on symptomatology and personality variables in AN patients.

3. To examine the long-term effects of neurofeedback in the treatment of AN.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• anorexia nervosa diagnosed by ICD-10

Exclusion Criteria:

• epilepsy or other brain organic diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Behavioral:
• neurofeedback training
training of individual alpha frequency, 10 sessions, each 15 min

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	brain activity in the alpha band	measuring selected variables pre/posttraining and follow-up and on 10 points of measurement (10 sessions neurofeedback)	10 sessions neurofeedback	Yes