Project Attention Deficit Hyperactivity Disorder (ADHD) and Electroencephalography (EEG)-Neurofeedback THERapy (PANther)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||ADHD and EEG-neurofeedback. A Single-blind Randomized Placebo-controlled Treatment Study.|
- 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 ] [ Designated as safety issue: No ]
- side-effects by Score on the adapted Pittsburgh side effects rating scale [ Time Frame: before, after 10, 20, 30 sessions ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Study Completion Date:||February 2013|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723684
|Nijmegen, Gelderland, Netherlands, 6525 GC|
|FC Donders Centre for Cognitive Neuroimaging|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Principal Investigator:||J.K. Buitelaar, Professor||UMC St. Radboud and Karakter|