Train Your Brain and Exercise Your Heart? Advancing the Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Interventions
- Registration Number
- NCT01363544
- Lead Sponsor
- R. van Mourik
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- ADHD diagnosis
- IQ above 80
- neurological disorder
- severe physical or cognitive disability
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description methylphenidate methylphenidate optimum dose of methylphenidate (assessed by a double blind placebo-controlled procedure) Exercise Exercise - Neurofeedback Neurofeedback -
- Primary Outcome Measures
Name Time Method Improvement in Behaviour 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
- Secondary Outcome Measures
Name Time Method Improvement in neurocognition 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 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
Trial Locations
- Locations (6)
GGZ InGeest
🇳🇱Amsterdam, Noord Holland, Netherlands
Stichting alles Kits
🇳🇱Rotterdam, Zuid Holland, Netherlands
Albert Schweitzer Ziekenhuis
🇳🇱Dordrecht, Zuid Holland, Netherlands
Maasstad Ziekenhuis
🇳🇱Rotterdam, Zuid Holland, Netherlands
Lucertis
🇳🇱Rotterdam, Zuid Holland, Netherlands
Yulius voor Geestelijke Gezondheid
🇳🇱Rotterdam, Zuid-Holland, Netherlands