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Attention Deficit Hyperactivity Disorder (ADHD)Phase 2/3NCT01363544

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

A Phase 2/3 study testing Neurofeedback, Exercise and methylphenidate in people with Attention Deficit Hyperactivity Disorder (ADHD), run by R. van Mourik at 6 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 13 yearsHealthy volunteers can take part
What is being tested?
Neurofeedback, Exercise and methylphenidate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
6 sitesNetherlands
Study dates
Jun 2010to Jan 2015
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 13 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • ADHD diagnosis
  • IQ above 80

Who cannot join

  • neurological disorder
  • severe physical or cognitive disability

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Netherlands6 sites

  • GGZ InGeest

    Amsterdam, North Holland, 1070BB Amsterdam

  • Albert Schweitzer Ziekenhuis

    Dordrecht, South Holland, 3300AK

  • Yulius voor Geestelijke Gezondheid

    Rotterdam, South Holland, 3014HH

  • Stichting alles Kits

    Rotterdam, South Holland, 3059 XA

  • Maasstad Ziekenhuis

    Rotterdam, South Holland, 3075EA

  • Lucertis

    Rotterdam, South Holland, 3083BD

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Neurofeedback, Exercise, methylphenidate
Keywords
ADHD, neurofeedback, exercise, neurophysiology
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeurofeedbackOther

    Also called biofeedback

    30 sessions of theta/beta neurofeedback within 10 weeks.

  • ExerciseBehavioural

    Also called sports

    30 sessions of individual sports training during 10 weeks.

  • methylphenidateDrug

    Also called Not applicable, a generic form will be used.

    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.

Study groups in NCT01363544
Study groupRoleWhat they receive
NeurofeedbackExperimentalNot described
Receives: Other: Neurofeedback
ExerciseExperimentalNot described
Receives: Behavioral: Exercise
methylphenidateActive comparatoroptimum dose of methylphenidate (assessed by a double blind placebo-controlled procedure)
Receives: Drug: methylphenidate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in Behaviour

    Behaviour is assessed with rating scales (SWAN, SDQ, SDSC,DCD) and actigraphy

    Measured: Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)

Secondary outcomes (2)

  1. Improvement in neurocognition

    Neuorcognition is assessed with several neuropsychological tests measuring inhibition, working memory, time estimation and probabilistic learning

    Measured: Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)

  2. Improvement in neurophysiology

    Neurophysiology is measured with ERPs and quantitative EEG

    Measured: Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2011 (estimated)
  2. Study startJun 2010
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01363544
Sponsor's protocol ID
ZonMw 157003012
Status last verified
Dec 2015
First submitted
20 May 2011
Last updated
9 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Janssen TWP, Gelade K, Bink M, van Mourik R, Twisk JWR, Maras A, Oosterlaan J. Long-term effects of theta/beta neurofeedback on EEG power spectra in children with attention deficit hyperactivity disorder. Clin Neurophysiol. 2020 Jun;131(6):1332-1341. doi: 10.1016/j.clinph.2020.02.020. Epub 2020 Mar 12.

    PubMed 32304847

  • Gelade K, Janssen TWP, Bink M, Twisk JWR, van Mourik R, Maras A, Oosterlaan J. A 6-month follow-up of an RCT on behavioral and neurocognitive effects of neurofeedback in children with ADHD. Eur Child Adolesc Psychiatry. 2018 May;27(5):581-593. doi: 10.1007/s00787-017-1072-1. Epub 2017 Nov 2.

    PubMed 29098467

  • Janssen TWP, Bink M, Weeda WD, Gelade K, van Mourik R, Maras A, Oosterlaan J. Learning curves of theta/beta neurofeedback in children with ADHD. Eur Child Adolesc Psychiatry. 2017 May;26(5):573-582. doi: 10.1007/s00787-016-0920-8. Epub 2016 Nov 19.

    PubMed 27866283

  • Gelade K, Janssen TW, Bink M, van Mourik R, Maras A, Oosterlaan J. Behavioral Effects of Neurofeedback Compared to Stimulants and Physical Activity in Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial. J Clin Psychiatry. 2016 Oct;77(10):e1270-e1277. doi: 10.4088/JCP.15m10149.

    PubMed 27631143

  • Janssen TW, Bink M, Gelade K, van Mourik R, Maras A, Oosterlaan J. A Randomized Controlled Trial Investigating the Effects of Neurofeedback, Methylphenidate, and Physical Activity on Event-Related Potentials in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2016 May;26(4):344-53. doi: 10.1089/cap.2015.0144. Epub 2016 Jan 15.

    PubMed 26771913

  • Janssen TW, Bink M, Gelade K, van Mourik R, Maras A, Oosterlaan J. A randomized controlled trial into the effects of neurofeedback, methylphenidate, and physical activity on EEG power spectra in children with ADHD. J Child Psychol Psychiatry. 2016 May;57(5):633-44. doi: 10.1111/jcpp.12517. Epub 2016 Jan 8.

    PubMed 26748531

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Neurofeedback, Exercise and methylphenidate in people with Attention Deficit Hyperactivity Disorder (ADHD), run by R. van Mourik at 6 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01363544, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.

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