Skip to main content
Clinical Trials/NCT01363544
NCT01363544
Completed
Phase 2

Train Your Brain? Exercise and Neurofeedback Intervention for ADHD

R. van Mourik6 sites in 1 country112 target enrollmentJune 2010

Overview

Phase
Phase 2
Intervention
Neurofeedback
Conditions
Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor
R. van Mourik
Enrollment
112
Locations
6
Primary Endpoint
Improvement in Behaviour
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
January 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
R. van Mourik
Responsible Party
Sponsor Investigator
Principal Investigator

R. van Mourik

Dr

VU University of Amsterdam

Eligibility Criteria

Inclusion Criteria

  • ADHD diagnosis
  • IQ above 80

Exclusion Criteria

  • neurological disorder
  • severe physical or cognitive disability

Arms & Interventions

Neurofeedback

Intervention: Neurofeedback

Exercise

Intervention: Exercise

methylphenidate

optimum dose of methylphenidate (assessed by a double blind placebo-controlled procedure)

Intervention: methylphenidate

Outcomes

Primary Outcomes

Improvement in Behaviour

Time Frame: Within 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 Outcomes

  • Improvement in neurocognition(Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2))
  • Improvement in neurophysiology(Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2))

Study Sites (6)

Loading locations...

Similar Trials