Clinical trial NCT03363568: Neuroplasticity Technology for Attention-deficit/Hyperactivity Disorder (ADHD)
Official title: Neuroplasticity Technology for Attention-deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Neuroscouting, L.L.C.
First posted: 2017-12-06
Enrollment: 41
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children were randomly assigned to adaptive treatment (n=20) or non-adaptive control (n=20) with identical tasks, stimuli, and goals. Children were instructed to train for 5 days a week (25m/day) for 4-weeks. All participants had between 10-20 training sessions at study completion.
Primary purpose: TREATMENT

Brief summary: This study evaluates the impact of computerized inhibitory control training on attention-deficit hyperactivity disorder (ADHD) symptoms and ADHD-linked neural signatures in children with ADHD. Children were randomly assigned to adaptive computerized training (n=20) or non-adaptive computerized training control (n=20) with identical stimuli and goals.

Detailed description: Both medication and cognitive behavioral therapy are effective treatments for many children, however, adherence to both medication and therapy regimes is low. Thus, identifying effective adjunct treatments for ADHD is imperative.

Previous studies exploring computerized training programs as supplementary treatments have targeted working memory or attention. However, many lines of research point to inhibitory control (IC) playing a central role in ADHD pathophysiology. IC abnormalities in children with ADHD have been evidenced both in behavioral performance on computerized tasks as well as in the structure and function of neural systems known to support IC function. Furthermore, these IC abnormalities have been linked to symptom severity.

Given findings that the most successful training interventions for children with ADHD are those that have implemented IC training along wtih working memory or attention and previous work demonstrating that IC is a central deficit for children with ADHD, it is surprising that no studies have sought to investigate programs that specifically target IC. Investigators hypothesize that training IC alone will decrease symptoms of ADHD, and information confirming this hypothesis would contribute to making training regimens for children with ADHD efficient by identifying the primary cognitive skill that requires intervention. To test this, they administer a randomized control trial of either adaptive of non-adaptive stop signal reaction time (SSRT) tasks to children with ADHD and assess effects of training on ADHD symptoms and neural activity.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of inattentive or combined subtype ADHD by a licensed clinician and consistent acess to Wi-Fi at home.

Exclusion Criteria:

* Any known genetic abnormalities, a diagnosis of autism spectrum disorder, or current use of medication for psychiatric disorders other than ADHD (e.g. depression, anxiety).

Primary outcomes:
measure: Change in Average Parent-Reported Inattention Symptoms
timeFrame: Baseline and 4-weeks
measure: Change in Average Parent-Reported Hyperactivity Symptoms
timeFrame: Baseline and 4-weeks
Secondary outcomes:
measure: Change in Relative Theta Power During Resting-State Electroencephalogram(EEG) Recording
timeFrame: Baseline and 4-weeks
measure: Change in Teacher Reported Inattention
timeFrame: Baseline and 4-weeks
measure: Change in Teacher Reported Hyperactivity
timeFrame: Baseline and 4-weeks
measure: Change in N200 Event-Related Potential (ERP) Component During Inhibition
timeFrame: Baseline and 4-weeks
Other outcomes:
measure: Change in NEPSY-II Inhibition Scale Score
timeFrame: Baseline and 4-weeks
measure: Change in Math Ability on the Woodcock Johnson III
timeFrame: Baseline and-4 weeks
measure: Change in Working Memory Capacity
timeFrame: Baseline and 4 weeks
measure: Changes in Inhibitory Control Over Rewarding Stimuli
timeFrame: Baseline and 4 weeks
measure: Changes in Behavior Rating Inventory of Executive Function Global Score
timeFrame: Baseline and 4 weeks
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Margaret Sheridan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barkley RA. Behavioral inhibition, sustained attention, and executive functions: constructing a unifying theory of ADHD. Psychol Bull. 1997 Jan;121(1):65-94. doi: 10.1037/0033-2909.121.1.65.
citation: Nigg JT. Is ADHD a disinhibitory disorder? Psychol Bull. 2001 Sep;127(5):571-98. doi: 10.1037/0033-2909.127.5.571.
citation: Vaidya CJ, Bunge SA, Dudukovic NM, Zalecki CA, Elliott GR, Gabrieli JD. Altered neural substrates of cognitive control in childhood ADHD: evidence from functional magnetic resonance imaging. Am J Psychiatry. 2005 Sep;162(9):1605-13. doi: 10.1176/appi.ajp.162.9.1605.
citation: Barry, R. J., and Clarke, A. R. (2012) Resting state EEG and symptoms of ADHD. Int. J. Psychophysiol. 85, 294.
citation: Rapport MD, Orban SA, Kofler MJ, Friedman LM. Do programs designed to train working memory, other executive functions, and attention benefit children with ADHD? A meta-analytic review of cognitive, academic, and behavioral outcomes. Clin Psychol Rev. 2013 Dec;33(8):1237-52. doi: 10.1016/j.cpr.2013.08.005. Epub 2013 Aug 24.
citation: Johnstone SJ, Roodenrys S, Phillips E, Watt AJ, Mantz S. A pilot study of combined working memory and inhibition training for children with AD/HD. Atten Defic Hyperact Disord. 2010 Mar;2(1):31-42. doi: 10.1007/s12402-009-0017-z. Epub 2010 Jan 28.
citation: Meyer KN, Santillana R, Miller B, Clapp W, Way M, Bridgman-Goines K, Sheridan MA. Computer-based inhibitory control training in children with Attention-Deficit/Hyperactivity Disorder (ADHD): Evidence for behavioral and neural impact. PLoS One. 2020 Nov 30;15(11):e0241352. doi: 10.1371/journal.pone.0241352. eCollection 2020.