Condition category
Mental and Behavioural Disorders
Date applied
20/01/2010
Date assigned
02/02/2010
Last edited
02/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Renate Drechsler

ORCID ID

Contact details

Neumuensterallee 9
Zurich
8032
Switzerland
renate.drechsler@kjpd.uzh.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Specificity of tomographic neurofeedback training compared to other biofeedback training methods in patients with ADHD: A randomised controlled trial.

Acronym

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

http://www.kjpd.uzh.ch/research/focus/focus1/Studien-Neurofeedback.pdf

Condition

Attention Deficit Hyperactivity Disorder (ADHD)

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

Quantitative measures of learned control during the biofeedback training.
Measured at each training session.

Overall trial start date

01/03/2009

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of ADHD
2. Children (age >8.5) and adults (age >18).

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. (Severe) psychiatric comorbidity
2. Neurological diseases
3. IQ<80

Recruitment start date

01/03/2009

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Switzerland

Trial participating centre

Neumuensterallee 9
Zurich
8032
Switzerland

Sponsor information

Organisation

University of Zurich (Switzerland)

Sponsor details

Department of Child and Adolescent Psychiatry
Neumuensterallee 3-9
Zurich
8032
Switzerland

Sponsor type

University/education

Website

http://www.kjpd.unizh.ch/index.html

Funders

Funder type

Government

Funder name

European Union - EU Project (COST-B27 ENOC / C06.0071)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department of Health of the Canton of Zurich (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes