Project Attention Deficit Hyperactivity Disorder (ADHD) and Electroencephalography (EEG)-Neurofeedback THERapy (PANther)
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|ClinicalTrials.gov Identifier: NCT00723684|
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : March 8, 2013
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.
- To investigate the efficacy of EEG-neurofeedback in reducing behavioral symptoms of ADHD.
- To investigate whether EEG-neurofeedback is able to improve neurocognitive functioning.
- To investigate whether EEG-neurofeedback is able to improve neural functioning.
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.
The hypothesis is EEG-Neurofeedback can reduce symptoms of ADHD.
|Condition or disease||Intervention/treatment||Phase|
|ADHD||Other: Placebo EEG Neurofeedback Other: EEG-Neurofeedback||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||ADHD and EEG-neurofeedback. A Single-blind Randomized Placebo-controlled Treatment Study.|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||February 2013|
Placebo Comparator: Placebo group
This group will receive no real EEG-Neurofeedback.
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.
Experimental: NF group
This group will receive real 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).
- ADHD criteria according to the DSM-IV-TR rated by the investigator. [ Time Frame: before, after 10, 20, 30 sessions and after half a year ]
- side-effects by Score on the adapted Pittsburgh side effects rating scale [ Time Frame: before, after 10, 20, 30 sessions ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723684
|FC Donders Centre for Cognitive Neuroimaging|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Nijmegen, Gelderland, Netherlands, 6525 GC|
|Principal Investigator:||J.K. Buitelaar, Professor||UMC St. Radboud and Karakter|