ADHD and EEG-neurofeedback. A Single-blind Randomized Placebo-controlled Treatment Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ADHD
- Sponsor
- Radboud University Medical Center
- Enrollment
- 63
- Locations
- 2
- Primary Endpoint
- ADHD criteria according to the DSM-IV-TR rated by the investigator.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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:
- 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.
Investigators
Prof. Jan Buitelaar
professor dr.
Radboud University Medical Center
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- side-effects by Score on the adapted Pittsburgh side effects rating scale(before, after 10, 20, 30 sessions)