Train Your Brain and Exercise Your Heart? Advancing the Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder (ADHD) |
Other: Neurofeedback Behavioral: Exercise Drug: methylphenidate |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Train Your Brain? Exercise and Neurofeedback Intervention for ADHD |
- Improvement in Behaviour [ Time Frame: Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2) ] [ Designated as safety issue: No ]Behaviour is assessed with rating scales (SWAN, SDQ, SDSC,DCD) and actigraphy
- Improvement in neurocognition [ Time Frame: Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2) ] [ Designated as safety issue: No ]Neuorcognition is assessed with several neuropsychological tests measuring inhibition, working memory, time estimation and probabilistic learning
- Improvement in neurophysiology [ Time Frame: Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2) ] [ Designated as safety issue: No ]Neurophysiology is measured with ERPs and quantitative EEG
| Estimated Enrollment: | 186 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Neurofeedback |
Other: Neurofeedback
30 sessions of theta/beta neurofeedback within 10 weeks.
Other Name: biofeedback
|
| Experimental: Exercise |
Behavioral: Exercise
30 sessions of individual sports training during 10 weeks.
Other Name: sports
|
|
Active Comparator: methylphenidate
optimum dose of methylphenidate (assessed by a double blind placebo-controlled procedure)
|
Drug: 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 Name: Not applicable, a generic form will be used.
|
Eligibility| Ages Eligible for Study: | 7 Years to 13 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- ADHD diagnosis
- IQ above 80
Exclusion Criteria:
- neurological disorder
- severe physical or cognitive disability
Contacts and Locations| Contact: Rosa van Mourik, PhD | +31 20 5988843 | r.van.mourik@psy.vu.nl |
| Contact: Jaap Oosterlaan, Professor | + 31 20 5988960 | j.ooosterlaan@psy.vu.nl |
| Netherlands | |
| GGZ InGeest | Recruiting |
| Amsterdam, Noord Holland, Netherlands, 1070BB Amsterdam | |
| Contact: Zeynel Erkut z.erkut@ggzingeest.nl | |
| Principal Investigator: Tieme Janssen, MSc | |
| Albert Schweitzer Ziekenhuis | Recruiting |
| Dordrecht, Zuid Holland, Netherlands, 3300AK | |
| Contact: Valentijn Drexhage, Md + 3178 654 11 11 v.r.drexhage@asz.nl | |
| Principal Investigator: Katleen Gelade, MSc | |
| Stichting alles Kits | Recruiting |
| Rotterdam, Zuid Holland, Netherlands, 3059 XA | |
| Contact: Dop Scheewe, Md + 31 10 2585703 'dopscheewe@alleskits.nl' | |
| Principal Investigator: Katleen Gelade, MSc | |
| Lucertis | Recruiting |
| Rotterdam, Zuid Holland, Netherlands, 3083BD | |
| Contact: Ellen Fliers, Md, PhD + 3110 49 60 640 e.fliers@lucertis.nl | |
| Principal Investigator: Katleen Gelade, MSc | |
| Maasstad Ziekenhuis | Recruiting |
| Rotterdam, Zuid Holland, Netherlands, 3075EA | |
| Contact: Rob Pereira, Md +31 10 291 19 11 PereiraR@maasstadziekenhuis.nl | |
| Principal Investigator: Katleen Gelade, MSc | |
| Yulius voor Geestelijke Gezondheid | Recruiting |
| Rotterdam, Zuid-Holland, Netherlands, 3014HH | |
| Contact: Katleen Gelade, MSc + 31 10 436 98 98 k.gelade@yulius.nl | |
| Contact: Athanasios Maras, Md, PhD + 31 10 436 98 98 A.Maras@yulius.nl | |
| Principal Investigator: Katleen Gelade, MSc | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Prof. E. Scherder, head of department of clinical neuropsychology, VU University, Faculty of Psychology and Education, department of clinical neuropsychology |
| ClinicalTrials.gov Identifier: | NCT01363544 History of Changes |
| Other Study ID Numbers: | ZonMw 157003012 |
| Study First Received: | May 20, 2011 |
| Last Updated: | May 27, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by VU University of Amsterdam:
|
ADHD neurofeedback exercise neurophysiology |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methylphenidate |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013