Train Your Brain and Exercise Your Heart? Advancing the Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
NCT ID: NCT01363544
Last Updated: 2015-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
112 participants
INTERVENTIONAL
2010-06-30
2015-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Neurofeedback
Neurofeedback
30 sessions of theta/beta neurofeedback within 10 weeks.
Exercise
Exercise
30 sessions of individual sports training during 10 weeks.
methylphenidate
optimum dose of methylphenidate (assessed by a double blind placebo-controlled procedure)
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.
Interventions
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Neurofeedback
30 sessions of theta/beta neurofeedback within 10 weeks.
Exercise
30 sessions of individual sports training during 10 weeks.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* IQ above 80
Exclusion Criteria
* severe physical or cognitive disability
7 Years
13 Years
ALL
Yes
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Yulius
UNKNOWN
R. van Mourik
OTHER
Responsible Party
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R. van Mourik
Dr
Principal Investigators
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Rosa van Mourik, PhD
Role: PRINCIPAL_INVESTIGATOR
VU University, faculty of psychology and education, department of clinical neuropsychology
Jaap Oosterlaan, Professor
Role: STUDY_DIRECTOR
VU University, Faculty of Psychology and Education, department of clinical neuropsychology
Locations
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GGZ InGeest
Amsterdam, North Holland, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, South Holland, Netherlands
Yulius voor Geestelijke Gezondheid
Rotterdam, South Holland, Netherlands
Stichting alles Kits
Rotterdam, South Holland, Netherlands
Maasstad Ziekenhuis
Rotterdam, South Holland, Netherlands
Lucertis
Rotterdam, South Holland, Netherlands
Countries
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References
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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.
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.
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.
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.
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.
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.
Related Links
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sponsor website
organization/sponsor website
Other Identifiers
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ZonMw 157003012
Identifier Type: -
Identifier Source: org_study_id