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
  Purpose

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 Intervention Phase
Attention Deficit Hyperactivity Disorder (ADHD)
Other: Neurofeedback
Behavioral: Exercise
Drug: methylphenidate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Train Your Brain? Exercise and Neurofeedback Intervention for ADHD

Resource links provided by NLM:


Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 186
Study Start Date: June 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   7 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ADHD diagnosis
  • IQ above 80

Exclusion Criteria:

  • neurological disorder
  • severe physical or cognitive disability
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363544

Locations
Netherlands
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
Lucertis
Rotterdam, Zuid Holland, Netherlands, 3083BD
Maasstad Ziekenhuis
Rotterdam, Zuid Holland, Netherlands, 3075EA
Yulius voor Geestelijke Gezondheid
Rotterdam, Zuid-Holland, Netherlands, 3014HH
Sponsors and Collaborators
R. van Mourik
ZonMw: The Netherlands Organisation for Health Research and Development
Yulius
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: R. van Mourik, Dr, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT01363544     History of Changes
Other Study ID Numbers: ZonMw 157003012
Study First Received: May 20, 2011
Last Updated: April 3, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VU University of Amsterdam:
ADHD
neurofeedback
exercise
neurophysiology

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014