Attention Deficit Hyperactivity Disorder
Conditions
Interventions
The fMRI-neurofeedback training will proceed as follows. Before the training
the subjects will be suggested a set of mental strategies that they may use
during the neurofeedback training (same set o
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.) Diagnosis of ADHD according to the DSM-IV TR criteria 2.) fMRI screening criteria 3.) Age > 18 4.) IQ > 85 5.) Psychopharmaca-naïve or -free, or being on a fixed dose of medication for the study period
Exclusion criteria
Exclusion criteria: 1.) Current diagnosis of one or more Axis I diagnosis other than ADHD according to the DSM-IV TR criteria 2.) Other significant medical condition/ regular use of medication other than psychostimulants 3.) Participation in another clinical trial simultaneously
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome messure • ADHD symptom score according to the ADHD DSM-IV rating scale Statistical Analysis (primary and secondary study parameters) Related to primary objective (1): Investigate whether fMRI-neurofeedback training reduces ADHD symptoms: For the ADHD symptom score, the sustained attention measures, the working memory measures, and the fMRI resting state anterior cingulate cortex connectivity several independent 2 x 2- way ANCOVAs (one per outcome measure) will be conducted (two-tailed, significance level is set at 5%) with session (pre-vs. post-treatment) as within-subjects factor, group (fMRI-neurofeedback vs. control neurofeedback) as between-subjects factor, and age, sex and IQ as covariates. For the cognitive interference measures, and the fMRI anterior cingulate cortex activation level/ connectivity during MSIT several independent 6 x 2- way ANCOVA (one per outcome measure) will be conducted (two-tailed, significance level is set at 5%) with session (number of training session) as within-subjects factor, group (fMRI-neurofeedback vs. control neurofeedback) as between-subjects factor, and age, sex and IQ as covariates. The influence of current state of motivation on training success will be calculated by computing non-parametric Spearman*s rank correlations within each individual patient. The mental strategies used will be scored and their influence on training success will be evaluated by computing non-parametric Spearman*s rank correlations within each individual patient. Related to primary objective (2): Investigate if the abnormal activation levels in ADHD patients play a causal role in ADHD pathophysiology: To estimate the influence of the neurofeedback training on the symptoms a measure of change in activation level during the neurofeedback training/ the transfer blocks at the end of the training will be developed. This measure (sessions x subjects) will be correlated with the performance on the MSIT task in th | — |
Secondary
| Measure | Time frame |
|---|---|
| Attention & Hyperactivity (before and after training) • Sustained attention score according to SA-DOTS and SART • Working memory score according to Digit Span and Nback-task • Anterior cingulate cortex activation connectivity during resting-state fMRI fMRI Neurofeedback Training (during each training session) • Current Motivation according to QCM • Cognitive interference score according to MSIT • Anterior cingulate cortex activation level during MSIT/ neurofeedback training • Mental strategies used during neurofeedback task | — |
Countries
Netherlands
Outcome results
None listed