Anorexia NervosaPhase 1/2NCT01390493
Therapeutic Effects of Neurofeedback in Anorexia Nervosa
A Phase 1/2 study testing neurofeedback training in people with Anorexia Nervosa, run by Medical University of Graz.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- neurofeedback training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Nov 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- anorexia nervosa diagnosed by ICD-10
Who cannot join
- epilepsy or other brain organic diseases
About this study
Official title: 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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- neurofeedback training
- Keywords
- neurofeedback, alpha, anorexia nervosa
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurofeedback trainingBehavioural
training of individual alpha frequency, 10 sessions, each 15 min
| Study group | Role | What they receive |
|---|---|---|
| neurofeedback, alpha power | Experimental | Not described Receives: Behavioral: neurofeedback training |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain activity in the alpha band
measuring selected variables pre/posttraining and follow-up and on 10 points of measurement (10 sessions neurofeedback)
Measured: 10 sessions neurofeedback
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startOct 2010
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Lackner, Mag., Principal investigator, Department of Psychology, Karl-Franzens-University Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390493
- Sponsor's protocol ID
- NEUROAN
- Status last verified
- Mar 2015
- First submitted
- 7 Jul 2011
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Alpha-neurofeedback in the Treatment of Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT01390493
- Acronym / sponsor ID
- NEUROAN
- Conditions
- Anorexia Nervosa
- Keywords
- neurofeedback, alpha, anorexia nervosa
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neurofeedback, alpha power | Experimental | Behavioral: neurofeedback training |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- anorexia nervosa diagnosed by ICD-10
Key exclusion criteria (1 listed)
- epilepsy or other brain organic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurofeedback trainingtraining of individual alpha frequency, 10 sessions, each 15 min | Behavioural | neurofeedback, alpha power |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Lackner, Mag. principal investigator
Department of Psychology, Karl-Franzens-University Graz
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing neurofeedback training in people with Anorexia Nervosa, run by Medical University of Graz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain activity in the alpha band (time frame: 10 sessions neurofeedback). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.