Neuroplasticity Technology for Attention-deficit/Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Neuroplasticity Technology for Attention-deficit/Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03363568
• Other study ID #: IRB-P00005840
• Status: Completed
• Phase: N/A
• First received: November 10, 2017
• Last updated: December 10, 2017
• Start date: July 18, 2013
• Est. completion date: March 3, 2014

Study information

• Verified date: December 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 3, 2014
• Est. primary completion date: March 3, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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).

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Hyperkinesis

Intervention

Behavioral:
• Adaptive Inhibitory Control Training
Playing computerized stop-signal reaction time tasks that had been modified to increase in difficulty as performance increased.
• Non-adaptive Inhibitory Control Training
Playing computerized stop-signal reactions time tasks that do not change in difficulty level (non-adaptive).

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children’s Hospital	Neuroscouting, L.L.C.

Country where clinical trial is conducted

United States, 

References & Publications (6)

Barkley RA. Behavioral inhibition, sustained attention, and executive functions: constructing a unifying theory of ADHD. Psychol Bull. 1997 Jan;121(1):65-94. Review. — View Citation

Barry, R. J., and Clarke, A. R. (2012) Resting state EEG and symptoms of ADHD. Int. J. Psychophysiol. 85, 294.

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. — View Citation

Nigg JT. Is ADHD a disinhibitory disorder? Psychol Bull. 2001 Sep;127(5):571-98. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in NEPSY-II Inhibition Scale Score	The Developmental NEuroPSYchological Assessment (NEPSY-II) is a nationally normed neuropsychological test for children ages 3-16 years. The Inhibition scale of the NEPSY includes an 'arrows' subtest (completed at baseline) and a 'shapes' subtest (completed at 4 weeks). Performance on these tests were measured as the number of total errors on each subtest task (Naming, Inhibition, and Switching), such that individuals who make more errors show poorer self-monitoring skills.	Baseline and 4-weeks
Other	Change in Math Ability on the Woodcock Johnson III	Math ability subtests of the Woodcok Johnson (WJ-III) were administered: Match Calculation (at baseline) and Match Fluency (at 4 weeks). Normed age and grade estimates of math ability were used. Outcomes are reported using age-based Z-scores, with a mean of 0 and standard deviation of 1.	Baseline and-4 weeks
Other	Change in Working Memory Capacity	Participants completed a working memory filtering task. This was a delayed match to sample task in which participants saw a visual array of several circles on a 4x4 grid, maintained this array in working memory during a delay, and decide if the color of a single probe matched what they saw during encoding. Changes in accuracy from same load trials in which children held 1 shape versus 2 shapes in working memory were used to assess filtering of task-irrelevant information. Changes in accuracy with load from the 1-shape condition are used to assess working memory capacity.	Baseline and 4 weeks
Other	Changes in Inhibitory Control Over Rewarding Stimuli	This was a two-part modified Go/NoGo task with a training phase and testing phase. Participants completed the monetary incentive delay (MID) task during training. Shapes that had been previously rewarded or previously neutral were used as the no-go stimuli in the Go/NoGo task. Errors of commission to the previously rewarded stimuli controlling for errors of commission to the previously neutral stimuli served as the measure of inhibitory control over rewarding stimuli.	Baseline and 4 weeks
Other	Changes in Behavior Rating Inventory of Executive Function Global Score	The Behavior Rating Inventory of Executive Function (BRIEF) is an assessment of executive function consisting of 86-item questionnaire completed by parents. The Global Score on the BRIEF incorporates all clinical scales of the BRIEF and is reported as a T-score with a mean of 50 and standard deviation of 10.	Baseline and 4 weeks
Primary	Change in Average Parent-Reported Inattention Symptoms	Parent-report of inattention symptoms using the Swanson, Nolan, and Pelham Questionnaire (SNAP-IV). The SNAP-IV is based on a 0 to 3 rating scale (Not at All = 0, Just A Little = 1, Quite a Bit = 2, and Very Much = 3). Subscale inattention items are calculated by summing the score for the 9 inattention items and dividing by 9.	Baseline and 4-weeks
Primary	Change in Average Parent-Reported Hyperactivity Symptoms	Parent-report of hyperactivity symptoms used the Swanson, Nolan, and Pelham Questionnaire (SNAP-IV). The SNAP-IV is based on a 0 to 3 rating scale (Not at All = 0, Just A Little = 1, Quite a Bit = 2, and Very Much = 3). Subscale hyperactivity items are calculated by summing the score for the 9 hyperactivity items and dividing by 9.	Baseline and 4-weeks
Secondary	Change in Relative Theta Power During Resting-State Electroencephalogram(EEG) Recording	EEG data was collected for both eyes open and eyes closed resting state for 7 trials of 30 seconds each. For each participant, relative power in the theta band (5-8 Hz) was calculated for two regions of interest analogous to bilateral parietal electrodes in the international 10-10 system using frequency band analyses.	Baseline and 4-weeks
Secondary	Change in Teacher Reported Inattention	Teachers or other non-parental caretakers (e.g. babysitter) completed the teacher report versions of the Conners. The Conner's is based on a 0 to 3 rating scale with 0 being Not true at all, 1 = Just a little true, 2 = pretty much true, and 3 = Very much true. The teacher-report inattention score was calculated by norming and averaging ratings of the inattention domains in the Conner's Teacher Report.	Baseline and 4-weeks
Secondary	Change in Teacher Reported Hyperactivity	Teachers or other non-parental caretakers (e.g. babysitter) completed the teacher report versions of the Conners. The Conner's is based on a 0 to 3 rating scale with 0 being Not true at all, 1 = Just a little true, 2 = pretty much true, and 3 = Very much true. The teacher-report hyperactivity score was calculated by norming and averaging ratings of the hyperactivity domains in the Conner's Teacher Report.	Baseline and 4-weeks
Secondary	Change in N200 Event-Related Potential (ERP) Component During Inhibition	The N200 is a negative going component maximal over frontal scalp cites, which peaks roughly between 200 and 350 ms post stimulus onset. Each subject's ERP response on both errors of commission and correct inhibition trials of a stop-signal reaction time task were analyzed for changes in amplitude and latency.	Baseline and 4-weeks