Clinical trial NCT01363544: Train Your Brain and Exercise Your Heart? Advancing the Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
Official title: Train Your Brain? Exercise and Neurofeedback Intervention for ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: ADHD
neurofeedback
exercise
neurophysiology
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Yulius
First posted: 2011-06-01
Enrollment: 112
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* ADHD diagnosis
* IQ above 80

Exclusion Criteria:

* neurological disorder
* severe physical or cognitive disability

Primary outcomes:
measure: Improvement in Behaviour
timeFrame: Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)
Secondary outcomes:
measure: Improvement in neurocognition
timeFrame: Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)
measure: Improvement in neurophysiology
timeFrame: Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: GGZ InGeest
state: Noord Holland
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Stichting alles Kits
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Lucertis
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Yulius voor Geestelijke Gezondheid
state: Zuid-Holland
Study officials:
affiliation: VU University, faculty of psychology and education, department of clinical neuropsychology
name: Rosa van Mourik, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VU University, Faculty of Psychology and Education, department of clinical neuropsychology
name: Jaap Oosterlaan, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.