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Sponsored by: |
Radboud University |
Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00723684 |
Background:
Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with ADHD in several mostly uncontrolled studies with relatively small sample sizes. It is unknown how EEG-neurofeedback affects brain functioning and exerts therapeutic effects in ADHD. This study 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.
Objectives:
Study design:
Double-blind randomized placebo-controlled treatment study.Study population: 120 subjects with ADHD (age 8-15, IQ of 80 or more). Intervention: 60 subjects with ADHD receive 30 sessions EEG-neurofeedback, and 60 subjects with ADHD receive placebo EEG-neurofeedback.
Main study parameter: ADHD-DSM-IV rating scale, rated by the investigator.
Hypothesis:
The hypothesis is EEG-Neurofeedback can reduce symptoms of ADHD.
Condition | Intervention |
ADHD |
Other: Placebo EEG Neurofeedback Other: EEG-Neurofeedback |
MedlinePlus related topics: | Attention Deficit Hyperactivity Disorder |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | ADHD and EEG-Neurofeedback. A Double-Blind Randomized Placebo-Controlled Treatment Study. |
Estimated Enrollment: | 120 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Placebo group: Placebo Comparator
This group will receive no real EEG-Neurofeedback.
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Other: Placebo EEG Neurofeedback
The placebo EEG-neurofeedback group will get an identical procedure as the real EEG-Neurofeedback, but with feedback on a EEG signal simulation. The placebo group will not be rewarded on their real-time EEG but on a random, simulated EEG; known to be effective for this purpose (Utrecht University, study in progress). In the protocol selection the electrode position and rewarding versus inhibition of the treatment frequency band or bands will be individually created. The first 30 seconds of the treatment will start on a predetermined fixed threshold value for all treatment subjects. |
NF group: Experimental
This group will receive real EEG-Neurofeedback
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Other: EEG-Neurofeedback
The EEG-neurofeedback group will receive feedback on their real-time EEG-signal (brain activity). The treatment group will be rewarded, by brightening (i.e. not being blackened of) the feedback screen. Rewards will be given to the subjects when their digitally filtered frequency EEG activity meets the criteria in the 'percentage time over threshold' parameter. The 'percentage time over threshold' parameter will be auto-adjusted on the digitally filtered real-time EEG every 30 seconds, and the percentage parameter will be kept as a constant over all participants during the entire study (i.e. not adjusted during treatment based on individual capabilities).
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Ages Eligible for Study: | 8 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contact: J.K. Buitelaar, Professor | 3613490/89 ext 024 | j.buitelaar@psy.umcn.nl |
Contact: M. Boomsma, MD | 024352222 | m.boomsma@psy.umcn.nl |
Netherlands, Gelderland | |||||
Karakter Nijmegen | Recruiting | ||||
Nijmegen, Gelderland, Netherlands, 6525 GC | |||||
Contact: M. Boomsma , MD | |||||
Principal Investigator: J.K. Buitelaar, professor | |||||
FC Donders Centre for Cognitive Neuroimaging | Recruiting | ||||
Nijmegen, Gelderland, Netherlands, 6500 HB | |||||
Contact: M. Zwiers, DR. 36 10750/10651 ext 24 | |||||
Sub-Investigator: M. Lansbergen, DR. |
Radboud University |
Principal Investigator: | J.K. Buitelaar, Professor | UMC St. Radboud and Karakter |
Responsible Party: | UMC St. Radboud ( Prof. J.K. Buitelaar ) |
Study ID Numbers: | NF1 |
First Received: | July 28, 2008 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00723684 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
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