Trial document





This trial has been registered retrospectively.
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  DRKS00006767

Trial Description

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Title

Biofeedback for Attention-deficit/Hyperactivity Disorder (ADHD) in adults: A comparison of different treatments: Slow cortical potentials feedback, frontal lobe oxygen consummation feedback and feedback of muscular tension/relaxation

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Trial Acronym

Feedback adults ADHD

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URL of the Trial

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Brief Summary in Lay Language

Background and study aims:
Attention-deficit/hyperactivity disorder (ADHD) is the most common behavioral disorder of childhood and also persists in 30-65% of children with ADHD into adulthood. Key symptoms include impaired attention, impulsivity hyperactivity, or more common in adults, inner restlessness.
At present, drugs like methylphenidate are the preferred treatment for ADHD, but especially for adults with ADHD there is a need for other treatment options. Among alternative treatments, neurofeedback is a non-invasive treatment for children with ADHD. Neurofeedback is a procedure that helps the individual to learn self-regulation of their ‘brain activity’ as recorded by an electroencephalogram (EEG) or other techniques that measure brain activity such as near-infrared spectroscopy (NIRS). The aim is that the participants learn to regulate their brain activity and by this reduce the ADHD symptoms. This should bring their neurophysiological profile closer to that of the non-ADHD population, resulting in improvements in behaviour and cognition.
This study will examine how well two different neurofeedback techniques work for adults with ADHD in comparison to an unspecific peripheral biofeedback treatment (muscular relaxation).

Who can participate?
Adults with a clinical diagnosis or suspected ADHD older than 18 years.

What does the study involve?
Interested individuals will undergo different measurements like questionnaires, interviews as well as EEG and NIRS recordings.
Participants will be randomly allocated to either 30 sessions of EEG feedback, NIRS feedback or biofeedback training. Each session will last about 60 minutes. After 15 sessions of training an in-between assessment will be made including questionnaires, EEG and NIRS measurement. After a break of three weeks the second half of the training will be conducted.
After the end of treatment and after a six-month period, follow-up examinations will be conducted focusing on the (long-term) effects.

What are the possible risks of participating?
Until now, no serious side effects of neurofeedback or peripheral biofeedback have been reported.

Where is the study run from?
Institute of Medical Psychology & Behavioral Neurobiology and University Hospital for Psychiatry & Psychotherapy,
University of Tübingen (Germany)

When is the study starting and how long is it expected to run for?
From January 2012 to March 2015.

Who is funding the study?
The project is funded by the Deutsche Forschungsgemeinschaft (DFG), Germany.

Who is the main contact?
Beatrix Barth
beatrix.barth@med.uni-tuebingen.de

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Brief Summary in Scientific Language

Attention deficit hyperactivity disorder (ADHD) is characterized by symptoms of inattention, impulsivity, and hyperactivity. Hitherto, only a few studies have investigated ADHD in an adult population and even less have investigated new forms of treatment such as neurofeedback training. Neurofeedback training has been applied effectively in various areas, especially in the treatment of children with ADHD. This study is designed to investigate the effect of slow cortical potentials (SPC) neurofeedback training and a new form of neurofeedback using near-infrared spectroscopy (NIRS) on symptomatology and neurophysiological parameters in an adult ADHD population.
A comparison of SCP and NIRS neurofeedback therapy methods has not been previously conducted and may yield valuable findings about alternative treatments for adult ADHD. The outcome of both neurofeedback techniques will be assessed after 30 training sessions and after a six months follow-up period and compared to unspecific biofeedback training. Furthermore, to investigate if training effects in this proof of principle study can be predicted by specific neurophysiological baseline parameters, regression models will be applied. Finally, a comparison with healthy controls will be conducted to evaluate deviant pre-training neurophysiological parameters, stability of assessment measures, and treatment outcome.

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Organizational Data

  •   DRKS00006767
  •   2014/10/08
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  •   yes
  •   Approved
  •   434/2010BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   F90 -  Hyperkinetic disorders
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Interventions/Observational Groups

  •   Neurofeedback therapy, 30 one hour sessions up to five times a week with 20 ADHD adults;
    Method: Feedback of EEG slow cortical potentials (< 0.1Hz) on electrode position Cz. The extent of activation and deactivation in term of slow electrical positive or negative shifts is displayed online on a computer screen to the patient and allows the patient to learn regulation and control over their brain activity via operant conditioning.
  •   Neurofeedback therapy, 30 one hour sessions up to five times a week with 20 ADHD adults;
    Method: Feedback of the oxygen level of the blood flow in the frontal lobe using near-infrared spectroscopy (NIRS). The extent of prefrontal activation in terms of changes in O2Hb concentration is displayed online on a computer screen to the patient and allows the patient to learn regulation and control over their brain activity via operant conditioning.
  •   Biofeedback therapy, 30 one hour sessions up to five times a week with 20 ADHD adults;
    Method: Feedback of muscular activity in the shoulder muscles. The extent of tension and relaxation of the left and right musculus supraspinatus is displayed online on a computer screen to the patient and allows the patient to learn regulation and control over their muscle tension via operant conditioning.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Change in ADHD Rating Scale (self-rated and third-party-rated) at pre treatment, after 15 sessions, after 30 sessions and at 6 months follow-up.

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Secondary Outcome

Assessment time points: before therapy = T1, after 15 sessions = T2, after 30 sessions = T3, after 6 months follow op = T4

Questionnaires:
- Wender ADHD interview - T1, T3, T4
- Becks Depression Index (BDI-II) - T1, T2, T3, T4
- Anxiety (STAI) - T1, T2, T3, T4
- Borderline Symptoms (BSL) - T1, T2, T3, T4

Behavioural tests:
- CFT-20-R IQ - T1, T3
- d2 attention test - T1, T3
Reaction and attention test:
- Reaction times - T1, T2, T3, T4
- Reaction time variability - T1, T2, T3, T4
- Error rates - T1, T2, T3, T4
- Wordfluency - T1, T2, T3, T4

Changes in Psychophysiology:
- EEG: Event related potentials, frequency bands activity - T1, T2, T3, T4
- NIRS: Blood oxygen level during cognitive performance - T1, T2, T3, T4

All these measurements compared to a healthy control group - T1, T3

Assessment of self-regulation ability over all 30 sessions

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/02/26
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1 - Attention Deficit Disorder inattentive type or hyperactive type or combined type according to DSM-IV criteria.
2 - No additional serious physical, neurological, or psychiatric disorders with the exception of moderate depression and personality disorders excluding anti-social or borderline personality disorders.
3 - Full scale IQ > 80

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Exclusion Criteria

1 - Self-reported diagnosis of the following current symptoms: Serious physical illness or chronic diseases such as lung disease, heart disease, diabetes, hypertension, and rheumatic diseases; Neurological disorders including Parkinson's disease, stroke, multiple sclerosis and epilepsy; indicated psychiatric disorders including bipolar disorder, psychosis, obsessive-compulsive disorder, chronic tics, Tourette syndrome, and suicidal behavior.
2 - Previous participation in another neurofeedback study.

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Addresses

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    • Eberhard Karls Universität Tübingen
    • 72076  Tübingen
    • Germany
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    • Institut für medizinische Psychologie und Neurobiologie
    • Ms.  Dr.  Kerstin  Mayer 
    • Silcherstrasse 5
    • 72076  Tübingen
    • Germany
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    • Klinik für Psychiatrie & Psychotherapie
    • Ms.  Dipl. Psych.  Beatrix  Barth 
    • Postanschrift: Calwerstr. 14
    • 72074  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.