Train Your Brain and Exercise Your Heart? Advancing the Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
Train Your Brain? Exercise and Neurofeedback Intervention for ADHD
1 other identifier
interventional
112
1 country
6
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2010
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 20, 2011
CompletedFirst Posted
Study publicly available on registry
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedDecember 9, 2015
December 1, 2015
4.6 years
May 20, 2011
December 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in Behaviour
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 Outcomes (2)
Improvement in neurocognition
Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)
Improvement in neurophysiology
Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)
Study Arms (3)
Neurofeedback
EXPERIMENTALExercise
EXPERIMENTALmethylphenidate
ACTIVE COMPARATORoptimum dose of methylphenidate (assessed by a double blind placebo-controlled procedure)
Interventions
30 sessions of theta/beta neurofeedback within 10 weeks.
30 sessions of individual sports training during 10 weeks.
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.
Eligibility Criteria
You may qualify if:
- ADHD diagnosis
- IQ above 80
You may not qualify if:
- neurological disorder
- severe physical or cognitive disability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- R. van Mouriklead
- ZonMw: The Netherlands Organisation for Health Research and Developmentcollaborator
- Yuliuscollaborator
Study Sites (6)
GGZ InGeest
Amsterdam, North Holland, 1070BB Amsterdam, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, South Holland, 3300AK, Netherlands
Yulius voor Geestelijke Gezondheid
Rotterdam, South Holland, 3014HH, Netherlands
Stichting alles Kits
Rotterdam, South Holland, 3059 XA, Netherlands
Maasstad Ziekenhuis
Rotterdam, South Holland, 3075EA, Netherlands
Lucertis
Rotterdam, South Holland, 3083BD, Netherlands
Related Publications (6)
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.
PMID: 32304847DERIVEDGelade 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.
PMID: 29098467DERIVEDJanssen 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.
PMID: 27866283DERIVEDGelade 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.
PMID: 27631143DERIVEDJanssen 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.
PMID: 26771913DERIVEDJanssen 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.
PMID: 26748531DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
May 20, 2011
First Posted
June 1, 2011
Study Start
June 1, 2010
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
December 9, 2015
Record last verified: 2015-12