Train Your Brain and Exercise Your Heart? Advancing the Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

Train Your Brain? Exercise and Neurofeedback Intervention for ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01363544
• Other study ID #: ZonMw 157003012
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 20, 2011
• Last updated: December 8, 2015
• Start date: June 2010
• Est. completion date: January 2015

Study information

• Verified date: December 2015
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 13 Years

Eligibility

Inclusion Criteria:

• ADHD diagnosis

• IQ above 80

Exclusion Criteria:

• neurological disorder

• severe physical or cognitive disability

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Hyperkinesis

Intervention

Other:
• Neurofeedback
30 sessions of theta/beta neurofeedback within 10 weeks.

Behavioral:
• Exercise
30 sessions of individual sports training during 10 weeks.

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.

Locations

Country	Name	City	State
Netherlands	GGZ InGeest	Amsterdam	Noord Holland
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht	Zuid Holland
Netherlands	Lucertis	Rotterdam	Zuid Holland
Netherlands	Maasstad Ziekenhuis	Rotterdam	Zuid Holland
Netherlands	Stichting alles Kits	Rotterdam	Zuid Holland
Netherlands	Yulius voor Geestelijke Gezondheid	Rotterdam	Zuid-Holland

Sponsors (3)

Lead Sponsor	Collaborator
R. van Mourik	Yulius, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Improvement in neurocognition	Neuorcognition is assessed with several neuropsychological tests measuring inhibition, working memory, time estimation and probabilistic learning	Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)	No
Secondary	Improvement in neurophysiology	Neurophysiology is measured with ERPs and quantitative EEG	Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)	No

External Links

•   organization website
•   organization/sponsor website
•   sponsor website