|
ISRCTN
|
ISRCTN82524080
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Neurofeedback with direct training of specific brain regions compared to other biofeedback training methods in patients with Attention Deficit Hyperactivity Disorder (ADHD)
|
|
Scientific title
|
Specificity of tomographic neurofeedback training compared to other biofeedback training methods in patients with ADHD: A randomised controlled trial.
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
There is growing evidence that neurofeedback training is an effective treatment method for ADHD, but its specificity and underlying mechanisms still need to be explored.
In this study, we investigate specific and unspecific effects of three biofeedback training methods: 1. tomographic neurofeedback, 2. conventional neurofeedback and 3. Electromyogram (EMG) biofeedback.
|
|
Ethics approval
|
The Cantonal Ethical Committee of the Canton of Zurich, Subcommission on psychiatry, neurology, neurosurgery (Kantonale Ethikkommission des Kantons Zürich, Unterkommission für Psychiatrie, Neurologie, Neurochirurgie) approved on the 3rd of October 2008 (ref: E57/2005)
|
|
Study design
|
Single centre prospective controlled randomised parallel groups intervention study
|
|
Countries of recruitment
|
Switzerland
|
|
Disease/condition/study domain
|
Attention Deficit Hyperactivity Disorder (ADHD)
|
|
Participants - inclusion criteria
|
1. Diagnosis of ADHD
2. Children (age >8.5) and adults (age >18).
|
|
Participants - exclusion criteria
|
1. (Severe) psychiatric comorbidity
2. Neurological diseases
3. IQ<80
|
|
Anticipated start date
|
01/03/2009
|
|
Anticipated end date
|
31/12/2010
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
http://www.kjpd.uzh.ch/research/focus/focus1/Studien-Neurofeedback.pdf
|
|
Target number of participants
|
80
|
|
Interventions
|
Interventions consist of three biofeedback-training methods, using the same training software and parallel training protocols:
1. Tomographic neurofeedback allows targeting the frontal brain regions which are most affected in ADHD (lateral and mesial), and train patients to modify their activation within these areas according to specific training protocols. To this end, current densities are computed using the standardized Low Resolution Brain Electromagnetic Tomography (sLORETA) algorithm and fed back visually to the subjects in order to change the activation in the particular Regions of Interest (ROIs).
2. In conventional neurofeedback the signal is fed back from the surface of the scalp by one electrode.
3. In EMG-biofeedback, fine motor regulation is fed back.
Duration: 18 double training sessions, over a period of 10-12 weeks. The total follow up time will be 3 months.
|
|
Primary outcome measure(s)
|
1. Clinical ADHD scales (parent-, teacher-, self-report)
2. Neuropsychological tests (subtests from computerised test batteries Test for Attentional Performance [TAP], Child-TAP [Kinder-TAP; KITAP] and D2)
3. Quantitative Electroencephalography (qEEG) and Event-Related Potentials (ERPs)
Measured at baseline and 3-month follow-up.
|
|
Secondary outcome measure(s)
|
Quantitative measures of learned control during the biofeedback training.
Measured at each training session.
|
|
Sources of funding
|
1. European Union - EU Project (COST-B27 ENOC / C06.0071)
2. Department of Health of the Canton of Zurich (Switzerland)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Renate
Drechsler
|
|
Address
|
Neumuensterallee 9
|
|
City/town
|
Zurich
|
|
Zip/Postcode
|
8032
|
|
Country
|
Switzerland
|
|
Email
|
renate.drechsler@kjpd.uzh.ch
|
|
Sponsor
|
University of Zurich (Switzerland)
|
|
Address
|
Department of Child and Adolescent Psychiatry
Neumuensterallee 3-9
|
|
City/town
|
Zurich
|
|
Zip/Postcode
|
8032
|
|
Country
|
Switzerland
|
|
Sponsor website:
|
http://www.kjpd.unizh.ch/index.html
|
|
Date applied
|
20/01/2010
|
|
Last edited
|
02/02/2010
|
|
Date ISRCTN assigned
|
02/02/2010
|
