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

December 8, 2015 updated by: R. van Mourik

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord Holland
      • Amsterdam, Noord Holland, Netherlands, 1070BB Amsterdam
        • GGz inGeest
    • Zuid Holland
      • Dordrecht, Zuid Holland, Netherlands, 3300AK
        • Albert Schweitzer Ziekenhuis
      • Rotterdam, Zuid Holland, Netherlands, 3059 XA
        • Stichting alles Kits
      • Rotterdam, Zuid Holland, Netherlands, 3075EA
        • Maasstad Ziekenhuis
      • Rotterdam, Zuid Holland, Netherlands, 3083BD
        • Lucertis
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3014HH
        • Yulius voor Geestelijke Gezondheid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ADHD diagnosis
  • IQ above 80

Exclusion Criteria:

  • neurological disorder
  • severe physical or cognitive disability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
Behavioral: Exercise
30 sessions of individual sports training during 10 weeks.
Other Names:
  • sports
Experimental: Neurofeedback
Other: Neurofeedback
30 sessions of theta/beta neurofeedback within 10 weeks.
Other Names:
  • biofeedback
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 Names:
  • Not applicable, a generic form will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)
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
Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R. van Mourik

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

May 20, 2011

First Submitted That Met QC Criteria

May 27, 2011

First Posted (Estimate)

June 1, 2011

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZonMw 157003012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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