Train Your Brain and Exercise Your Heart? Advancing the Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
|ClinicalTrials.gov Identifier: NCT01363544|
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : December 9, 2015
Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that has a severe impact on a child's life and society. The core symptoms are attention problems, hyperactivity and impulsivity. These symptoms are related to disruptions in neurocognitive functions (such as inhibition: the ability to stop behavior) and disruptions in cortical regulation (such as 'cortical underarousal' as measured with the electroencephalogram). To date, the only evidence-based treatment is pharmacological. Medication is not effective in 20-30% of the children with ADHD and it can have side effects. The lack of alternatives for medication is a severe problem for these children and society.
Neurofeedback is becoming increasingly popular for treating ADHD. Neurofeedback is a training in which a person learns to alter its cortical regulation. Neurofeedback has been classified as 'probably effective' but its treatment effects need further empirical evidence. Non specific training effects, such as individual attention, may also contribute to treatment success. In this research project the investigators compare the efficacy of neurofeedback with exercise, a second non-pharmacological treatment, that may be comparable with neurofeedback in terms of non-specific effects. Exercise is also a promising treatment because of its positive effects on behavior, neurocognition in several patient groups. For these reasons, exercise deserves systematic research in ADHD. Furthermore, the investigators compare the efficacy of these two treatments with an optimal pharmacological treatment with methylphenidate (MPH). The main question is if neurofeedback and exercise are comparable in efficacy with MPH for treating ADHD. The primary outcome measure is behaviour (symptoms of ADHD). Secondary outcome measures include neurocognition and cortical regulation. This research project will give answer to the question if neurofeedback and exercise are as effective as MPH. Furthermore, it will give insight in how these interventions will give rise to improvements in behavior.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder (ADHD)||Other: Neurofeedback Behavioral: Exercise Drug: methylphenidate||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Train Your Brain? Exercise and Neurofeedback Intervention for ADHD|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
30 sessions of theta/beta neurofeedback within 10 weeks.
Other Name: biofeedback
30 sessions of individual sports training during 10 weeks.
Other Name: sports
Active Comparator: methylphenidate
optimum dose of methylphenidate (assessed by a double blind placebo-controlled procedure)
The medication treatment is based on the MTA study and includes methylphenidate dosages of 5, 10, 15 (only for children with a weight below 25 kg) and 20 mg (only for children with a weight above 25 kg. The optimum dose will be determined by a double-blind placebo-controlled trial.
Other Name: Not applicable, a generic form will be used.
- Improvement in Behaviour [ Time Frame: Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2) ]Behaviour is assessed with rating scales (SWAN, SDQ, SDSC,DCD) and actigraphy
- Improvement in neurocognition [ Time Frame: Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2) ]Neuorcognition is assessed with several neuropsychological tests measuring inhibition, working memory, time estimation and probabilistic learning
- Improvement in neurophysiology [ Time Frame: Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2) ]Neurophysiology is measured with ERPs and quantitative EEG
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363544
|Amsterdam, Noord Holland, Netherlands, 1070BB Amsterdam|
|Albert Schweitzer Ziekenhuis|
|Dordrecht, Zuid Holland, Netherlands, 3300AK|
|Stichting alles Kits|
|Rotterdam, Zuid Holland, Netherlands, 3059 XA|
|Rotterdam, Zuid Holland, Netherlands, 3075EA|
|Rotterdam, Zuid Holland, Netherlands, 3083BD|
|Yulius voor Geestelijke Gezondheid|
|Rotterdam, Zuid-Holland, Netherlands, 3014HH|
|Principal Investigator:||Rosa van Mourik, PhD||VU University, faculty of psychology and education, department of clinical neuropsychology|
|Study Director:||Jaap Oosterlaan, Professor||VU University, Faculty of Psychology and Education, department of clinical neuropsychology|