- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00723684
Project Attention Deficit Hyperactivity Disorder (ADHD) and Electroencephalography (EEG)-Neurofeedback THERapy (PANther)
ADHD and EEG-neurofeedback. A Single-blind Randomized Placebo-controlled Treatment Study.
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:
- 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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gelderland
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Nijmegen, Gelderland, Netherlands, 6500 HB
- FC Donders Centre for Cognitive Neuroimaging
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Nijmegen, Gelderland, Netherlands, 6525 GC
- Karakter Nijmegen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo group
This group will receive no real 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
before, after 10, 20, 30 sessions and after half a year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
side-effects by Score on the adapted Pittsburgh side effects rating scale
Time Frame: before, after 10, 20, 30 sessions
|
before, after 10, 20, 30 sessions
|
Collaborators and Investigators
Investigators
- Principal Investigator: J.K. Buitelaar, Professor, UMC St. Radboud and Karakter
Publications and helpful links
General Publications
- Vollebregt MA, van Dongen-Boomsma M, Buitelaar JK, Slaats-Willemse D. Does EEG-neurofeedback improve neurocognitive functioning in children with attention-deficit/hyperactivity disorder? A systematic review and a double-blind placebo-controlled study. J Child Psychol Psychiatry. 2014 May;55(5):460-72. doi: 10.1111/jcpp.12143. Epub 2013 Oct 30. Erratum In: J Child Psychol Psychiatry. 2014 Aug;55(8):954-5. J Child Psychol Psychiatry. 2014 Aug;55(8):954-955.
- van Dongen-Boomsma M, Vollebregt MA, Slaats-Willemse D, Buitelaar JK. A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2013 Aug;74(8):821-7. doi: 10.4088/JCP.12m08321.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NF1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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