Working… Menu

Project Attention Deficit Hyperactivity Disorder (ADHD) and Electroencephalography (EEG)-Neurofeedback THERapy (PANther)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00723684
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : March 8, 2013
Information provided by (Responsible Party):
Prof. Jan Buitelaar, Radboud University

Brief Summary:


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.


  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.

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.


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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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).

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. side-effects by Score on the adapted Pittsburgh side effects rating scale [ Time Frame: before, after 10, 20, 30 sessions ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis ADHD, classified by the (Diagnostic and Statistical Manual of Mental Disorders, 2000)
  • Age between 8 and 15
  • A full scale IQ of more than 80
  • Psychopharmaca- naïve or -free, or using a stable dosage of psychostimulants or atomoxetine but still with room for improvement (defined by an average score of more than 1 on ADHD-DSM-IV rating scale).
  • Deviant EEG of more than 1.5 standard deviation compared to the database

Exclusion criteria:

  • Currently intensive (i.e. weekly) individual or group psychotherapy
  • Regular use of medication other than psychostimulants or atomoxetine
  • Diagnosis of one or more of the following comorbid psychiatric disorders:
  • Major depression
  • Bipolar disorder
  • Psychotic disorder
  • Chronically motor tic disorder or Gilles de la Tourette
  • Conduct disorder
  • Autism spectrum disorders
  • Eating disorders
  • Neurological disorders (e.g. epilepsy) currently or in the past
  • Cardiovascular disease currently or in the past
  • Participation in another clinical trial simultaneously
  • EEG-neurofeedback training in the past
  • Use of alcohol or drugs

Information from the National Library of Medicine

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 identifier (NCT number): NCT00723684

Layout table for location information
FC Donders Centre for Cognitive Neuroimaging
Nijmegen, Gelderland, Netherlands, 6500 HB
Karakter Nijmegen
Nijmegen, Gelderland, Netherlands, 6525 GC
Sponsors and Collaborators
Radboud University
Layout table for investigator information
Principal Investigator: J.K. Buitelaar, Professor UMC St. Radboud and Karakter