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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01363544
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : December 9, 2015
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
R. van Mourik, VU University of Amsterdam

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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Neurofeedback Other: Neurofeedback
30 sessions of theta/beta neurofeedback within 10 weeks.
Other Name: biofeedback
Experimental: Exercise Behavioral: Exercise
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)
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • ADHD diagnosis
  • IQ above 80

Exclusion Criteria:

  • neurological disorder
  • severe physical or cognitive disability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01363544

GGZ InGeest
Amsterdam, Noord Holland, Netherlands, 1070BB Amsterdam
Albert Schweitzer Ziekenhuis
Dordrecht, Zuid Holland, Netherlands, 3300AK
Stichting alles Kits
Rotterdam, Zuid Holland, Netherlands, 3059 XA
Maasstad Ziekenhuis
Rotterdam, Zuid Holland, Netherlands, 3075EA
Rotterdam, Zuid Holland, Netherlands, 3083BD
Yulius voor Geestelijke Gezondheid
Rotterdam, Zuid-Holland, Netherlands, 3014HH
Sponsors and Collaborators
R. van Mourik
ZonMw: The Netherlands Organisation for Health Research and Development
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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: R. van Mourik, Dr, VU University of Amsterdam Identifier: NCT01363544     History of Changes
Other Study ID Numbers: ZonMw 157003012
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015

Keywords provided by R. van Mourik, VU University of Amsterdam:

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents