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

ADHD Clinical Trial

— PANther  

Official title:

ADHD and EEG-neurofeedback. A Single-blind Randomized Placebo-controlled Treatment Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723684
• Other study ID #: NF1
• Status: Completed
• Phase: N/A
• First received: July 28, 2008
• Last updated: March 7, 2013
• Start date: July 2008
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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:

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.

Hypothesis:

The hypothesis is EEG-Neurofeedback can reduce symptoms of ADHD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: February 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 15 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

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.
• 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).

Locations

Country	Name	City	State
Netherlands	FC Donders Centre for Cognitive Neuroimaging	Nijmegen	Gelderland
Netherlands	Karakter Nijmegen	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD criteria according to the DSM-IV-TR rated by the investigator.		before, after 10, 20, 30 sessions and after half a year	No
Secondary	side-effects by Score on the adapted Pittsburgh side effects rating scale		before, after 10, 20, 30 sessions	Yes