Train Your Brain and Exercise Your Heart? Advancing the Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Hyperactivity Disorder (ADHD)
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Neurofeedback
Exercise
methylphenidate
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring ADHD, neurofeedback, exercise, neurophysiology
Eligibility Criteria
Inclusion Criteria:
- ADHD diagnosis
- IQ above 80
Exclusion Criteria:
- neurological disorder
- severe physical or cognitive disability
Sites / Locations
- GGZ InGeest
- Albert Schweitzer Ziekenhuis
- Stichting alles Kits
- Maasstad Ziekenhuis
- Lucertis
- Yulius voor Geestelijke Gezondheid
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Neurofeedback
Exercise
methylphenidate
Arm Description
optimum dose of methylphenidate (assessed by a double blind placebo-controlled procedure)
Outcomes
Primary Outcome Measures
Improvement in Behaviour
Behaviour is assessed with rating scales (SWAN, SDQ, SDSC,DCD) and actigraphy
Secondary Outcome Measures
Improvement in neurocognition
Neuorcognition is assessed with several neuropsychological tests measuring inhibition, working memory, time estimation and probabilistic learning
Improvement in neurophysiology
Neurophysiology is measured with ERPs and quantitative EEG
Full Information
NCT ID
NCT01363544
First Posted
May 20, 2011
Last Updated
December 8, 2015
Sponsor
R. van Mourik
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Yulius
1. Study Identification
Unique Protocol Identification Number
NCT01363544
Brief Title
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
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
R. van Mourik
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Yulius
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder (ADHD)
Keywords
ADHD, neurofeedback, exercise, neurophysiology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neurofeedback
Arm Type
Experimental
Arm Title
Exercise
Arm Type
Experimental
Arm Title
methylphenidate
Arm Type
Active Comparator
Arm Description
optimum dose of methylphenidate (assessed by a double blind placebo-controlled procedure)
Intervention Type
Other
Intervention Name(s)
Neurofeedback
Other Intervention Name(s)
biofeedback
Intervention Description
30 sessions of theta/beta neurofeedback within 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
sports
Intervention Description
30 sessions of individual sports training during 10 weeks.
Intervention Type
Drug
Intervention Name(s)
methylphenidate
Other Intervention Name(s)
Not applicable, a generic form will be used.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in Behaviour
Description
Behaviour is assessed with rating scales (SWAN, SDQ, SDSC,DCD) and actigraphy
Time Frame
Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)
Secondary Outcome Measure Information:
Title
Improvement in neurocognition
Description
Neuorcognition is assessed with several neuropsychological tests measuring inhibition, working memory, time estimation and probabilistic learning
Time Frame
Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)
Title
Improvement in neurophysiology
Description
Neurophysiology is measured with ERPs and quantitative EEG
Time Frame
Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ADHD diagnosis
IQ above 80
Exclusion Criteria:
neurological disorder
severe physical or cognitive disability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa van Mourik, PhD
Organizational Affiliation
VU University, faculty of psychology and education, department of clinical neuropsychology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jaap Oosterlaan, Professor
Organizational Affiliation
VU University, Faculty of Psychology and Education, department of clinical neuropsychology
Official's Role
Study Director
Facility Information:
Facility Name
GGZ InGeest
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1070BB Amsterdam
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
State/Province
Zuid Holland
ZIP/Postal Code
3300AK
Country
Netherlands
Facility Name
Stichting alles Kits
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3059 XA
Country
Netherlands
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3075EA
Country
Netherlands
Facility Name
Lucertis
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3083BD
Country
Netherlands
Facility Name
Yulius voor Geestelijke Gezondheid
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3014HH
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
32304847
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.
Results Reference
derived
PubMed Identifier
29098467
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.
Results Reference
derived
PubMed Identifier
27866283
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.
Results Reference
derived
PubMed Identifier
27631143
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.
Results Reference
derived
PubMed Identifier
26771913
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.
Results Reference
derived
PubMed Identifier
26748531
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.
Results Reference
derived
Links:
URL
http://www.zonmw.nl/
Description
sponsor website
URL
http://www.yulius.nl
Description
organization/sponsor website
Learn more about this trial
Train Your Brain and Exercise Your Heart? Advancing the Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
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