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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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01363544
Enrollment
112
Registered
2011-06-01
Start date
2010-06-30
Completion date
2015-01-31
Last updated
2015-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

ADHD, neurofeedback, exercise, neurophysiology

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.

Interventions

OTHERNeurofeedback

30 sessions of theta/beta neurofeedback within 10 weeks.

BEHAVIORALExercise

30 sessions of individual sports training during 10 weeks.

DRUGmethylphenidate

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.

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
Yulius
CollaboratorUNKNOWN
R. van Mourik
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 13 Years
Healthy volunteers
Yes

Inclusion criteria

* ADHD diagnosis * IQ above 80

Exclusion criteria

* neurological disorder * severe physical or cognitive disability

Design outcomes

Primary

MeasureTime frameDescription
Improvement in BehaviourWithin 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)Behaviour is assessed with rating scales (SWAN, SDQ, SDSC,DCD) and actigraphy

Secondary

MeasureTime frameDescription
Improvement in neurocognitionWithin 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)Neuorcognition is assessed with several neuropsychological tests measuring inhibition, working memory, time estimation and probabilistic learning
Improvement in neurophysiologyWithin 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)Neurophysiology is measured with ERPs and quantitative EEG

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026