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

R. van Mourik

Status and phase: Completed; Phase 3; Phase 2

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Treatments: Drug: methylphenidate; Behavioral: Exercise; Other: Neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT01363544

ZonMw 157003012

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 7 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ADHD diagnosis
• IQ above 80

Exclusion criteria

• neurological disorder
• severe physical or cognitive disability

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 3 patient groups

Neurofeedback

Experimental group

Treatment:

Other: Neurofeedback

Exercise

Experimental group

Treatment:

Behavioral: Exercise

methylphenidate

Active Comparator group

Description:

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

Treatment:

Drug: methylphenidate