1) To investigate the efficacy of EEG-neurofeedback in reducing behavioral symptoms of ADHD.2) To investigate whether EEG-neurofeedback is able to improve neurocognitive functioning. 3) To investigate whether EEG-neurofeedback is able to improve…
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
ADHD-DSM-IV rating scale, rated by the investigator
Secondary outcome
scores on all neuropsychological tasks
absolute en relative power of 4 frequenties EEG bands
fluctuations in de BOLD signals on fMRI
measures on the diffusion Tensor Imaging (DTI)
Background summary
EEG-neurofeedback has been shown to offer therapeutic benefits to patients with
ADHD in several relatively small and mostly uncontrolled studies. It is unknown
how EEG-neurofeedback affects brain functioning and exerts therapeutic effects
in ADHD. This controlled treatment is designed to examine the efficacy and
safety of EEG-neurofeedback in a scientific rigorously way and to study the
underlying neurobiological mechanisms of EEG-neurofeedback.
Study objective
1) To investigate the efficacy of EEG-neurofeedback in reducing behavioral
symptoms of ADHD.
2) To investigate whether EEG-neurofeedback is able to improve neurocognitive
functioning.
3) To investigate whether EEG-neurofeedback is able to improve neural
functioning/connectivity.
Study design
Double-blind randomized placebo-controlled treatment study
Intervention
60 subjects with ADHD receive 30 sessions EEG-neurofeedback, 60 subjects with
ADHD receive placebo EEG-neurofeedback.
Study burden and risks
Risks or side-effects are not expected. The burden for the ADHD subjects in the
two treatment modalities exists of the pre- and post-treatment assessment
(different duration, depending on fMRI allocation) and 30 visits of
approximately 45 minutes for the EEG-neurofeedback. The benefit exists of the a
priori change of positive effect of the EEG-neurofeedback on ADHD symptoms.
Reinier Postlaan 10
6525 GC Nijmegen
NL
Reinier Postlaan 10
6525 GC Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Diagnosis ADHD (classified by the DSM-IV TR)
Age between 8 and 15
A full scale IQ ³ 80
Medication- naïve, or using psychostimulants/atomoxetine but still with room for improvement
Exclusion criteria
Currently intensive (i.e. weekly) individual or group psychotherapy.
Use of medication other than psychopharmaca
Diagnosis of one or more of the following comorbid psychiatric disorders:
Major depression or dysthymie
Anxiety disorder
Bipolar disorder
Psychotic disorder
Chronical motor tic disorder or Gilles de la Tourette
Conduct disorder
Autism spectrum disorders
Eating disorders
Cardiovascular disease currently/in the past
Neurological disorders (e.g. epilepsy) currently or in the past
Participation in another clinical trial simultaneously
Neurofeedback training in the past
Metal parts in body
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21590.091.08 |