Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial
Official title:
Train Your Brain? Exercise and Neurofeedback Intervention for ADHD
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03260205 -
Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
|
Phase 3 | |
| Withdrawn |
NCT03546400 -
Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.
|
Phase 4 | |
| Completed |
NCT02917109 -
LearningRx Cognitive Training for ADHD
|
N/A | |
| Completed |
NCT02248948 -
Superiority of Omega-3 Versus Placebo on the Improvement of ADHD in Children
|
N/A | |
| Recruiting |
NCT01750307 -
The Relationship of Essential Fatty Acids to Adult ADHD: The OCEAN Study (Oils and Cognitive Effects in Adult ADHD Neurodevelopment)
|
N/A | |
| Recruiting |
NCT06170996 -
Internet-Assisted Behavioral Parent Training Intervention for Children With Attention Deficit Hyperactivity Disorder
|
N/A | |
| Completed |
NCT00735371 -
Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
|
Phase 3 | |
| Withdrawn |
NCT03580005 -
A 6-week Study to Evaluate the Safety and Efficacy of Quillichew ERCT in 4-5 Year Old Children With ADHD.
|
Phase 4 | |
| Completed |
NCT02578030 -
Pharmacokinetic Study in Children and Adolescents Aged 6 to 17 Years Who Have Been Diagnosed With ADHD
|
Phase 1 | |
| Completed |
NCT02574273 -
Pilot Trial of a Social Skills Group Treatment (Secret Agent Society Program)
|
N/A | |
| Completed |
NCT02257216 -
Vayarin® Medical Food Study for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
|
N/A | |
| Recruiting |
NCT04943796 -
A Study to Learn About the Occurrence of ADHD in Adults With Mental Conditions and Their Quality of Life
|
||
| Recruiting |
NCT04634006 -
Home-Based tDCS in Children With ADHD: A Randomized, Sham-Controlled tDCS and fNIRS Study
|
N/A | |
| Active, not recruiting |
NCT02908802 -
Probiotic Supplement as Treatment for Students With ADHD
|
N/A | |
| Completed |
NCT02604407 -
Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
|
Phase 3 | |
| Completed |
NCT05870605 -
Drug Use Study With Intuniv® in European Countries
|
||
| Terminated |
NCT03481959 -
Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity
|
Phase 3 | |
| Terminated |
NCT03638466 -
Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With Attention-Deficit/Hyperactivity Disorder
|
Phase 2 | |
| Completed |
NCT03709940 -
Brain Connectivity in Attention Deficit Hyperactivity Disorder (ADHD)
|
N/A | |
| Completed |
NCT02795637 -
Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction
|
Phase 1 |