Train Your Brain and Exercise Your Heart? Advancing the Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Yulius
Information provided by (Responsible Party):
R. van Mourik, VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT01363544
First received: May 20, 2011
Last updated: April 3, 2014
Last verified: April 2014

May 20, 2011
April 3, 2014
June 2010
April 2014   (final data collection date for primary outcome measure)
Improvement in Behaviour [ Time Frame: Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2) ] [ Designated as safety issue: No ]
Behaviour is assessed with rating scales (SWAN, SDQ, SDSC,DCD) and actigraphy
Same as current
Complete list of historical versions of study NCT01363544 on ClinicalTrials.gov Archive Site
  • Improvement in neurocognition [ Time Frame: Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Neurophysiology is measured with ERPs and quantitative EEG
Same as current
Not Provided
Not Provided
 
Train Your Brain and Exercise Your Heart? Advancing the Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
Train Your Brain? Exercise and Neurofeedback Intervention for ADHD

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder (ADHD)
  • Other: Neurofeedback
    30 sessions of theta/beta neurofeedback within 10 weeks.
    Other Name: biofeedback
  • Behavioral: Exercise
    30 sessions of individual sports training during 10 weeks.
    Other Name: sports
  • Drug: methylphenidate
    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.
  • Experimental: Neurofeedback
    Intervention: Other: Neurofeedback
  • Experimental: Exercise
    Intervention: Behavioral: Exercise
  • Active Comparator: methylphenidate
    optimum dose of methylphenidate (assessed by a double blind placebo-controlled procedure)
    Intervention: Drug: methylphenidate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
186
October 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ADHD diagnosis
  • IQ above 80

Exclusion Criteria:

  • neurological disorder
  • severe physical or cognitive disability
Both
7 Years to 13 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01363544
ZonMw 157003012
No
R. van Mourik, VU University of Amsterdam
R. van Mourik
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • Yulius
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
VU University of Amsterdam
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP