ADHD Clinical Trial
Official title:
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:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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