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NCT Number: NCT01363544

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

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Key information

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

GGZ InGeest, Amsterdam, North Holland, Netherlands

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ADHD diagnosis
  • IQ above 80

Exclusion criteria

  • neurological disorder
  • severe physical or cognitive disability

Treatment and study plan

Neurofeedback

Other

30 sessions of theta/beta neurofeedback within 10 weeks.

Other names: biofeedback

Exercise

Behavioral

30 sessions of individual sports training during 10 weeks.

Other names: sports

Methylphenidate

Drug

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 names: Not applicable, a generic form will be used.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

R. van Mourik

Other

Collaborators

  • Yulius
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Train Your Brain? Exercise and Neurofeedback Intervention for ADHD

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jun 1, 2011
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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