Train Your Brain and Exercise Your Heart? Advancing the Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    


Intervention name(s): Neurofeedback; Exercise; methylphenidate
Intervention type(s): Other; Behavioral; Drug
Intervention description(s): 30 sessions of theta/beta neurofeedback within 10 weeks.; 30 sessions of individual sports training during 10 weeks.; 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 intervention name(s): biofeedback; sports; Not applicable, a generic form will be used.
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; neurofeedback; exercise; neurophysiology