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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adaptive Inhibitory Control Training
Non-adaptive Inhibitory Control Training
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

8 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adaptive Inhibitory Control Training

Non-Adaptive Inhibitory Control Training

Arm Description

Participants played a set of three modified stop-signal reaction time tasks designed by NeuroScouting, LLC at home for approximately 5 days a week (25 min/day) for 4-weeks. This condition involved real-time adaptive gameplay that increased in difficulty as performance increased.

Participants played a set of three modified stop-signal reaction time tasks designed by NeuroScouting, LLC at home for approximately 5 days a week (25 min/day) for 4-weeks. This condition had no change in difficulty (non-adaptive gameplay).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
November 10, 2017
Last Updated
December 10, 2017
Sponsor
Boston Children's Hospital
Collaborators
Neuroscouting, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT03363568
Brief Title
Neuroplasticity Technology for Attention-deficit/Hyperactivity Disorder (ADHD)
Official Title
Neuroplasticity Technology for Attention-deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 18, 2013 (Actual)
Primary Completion Date
March 3, 2014 (Actual)
Study Completion Date
March 3, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Neuroscouting, L.L.C.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adaptive Inhibitory Control Training
Arm Type
Experimental
Arm Description
Participants played a set of three modified stop-signal reaction time tasks designed by NeuroScouting, LLC at home for approximately 5 days a week (25 min/day) for 4-weeks. This condition involved real-time adaptive gameplay that increased in difficulty as performance increased.
Arm Title
Non-Adaptive Inhibitory Control Training
Arm Type
Active Comparator
Arm Description
Participants played a set of three modified stop-signal reaction time tasks designed by NeuroScouting, LLC at home for approximately 5 days a week (25 min/day) for 4-weeks. This condition had no change in difficulty (non-adaptive gameplay).
Intervention Type
Behavioral
Intervention Name(s)
Adaptive Inhibitory Control Training
Intervention Description
Playing computerized stop-signal reaction time tasks that had been modified to increase in difficulty as performance increased.
Intervention Type
Behavioral
Intervention Name(s)
Non-adaptive Inhibitory Control Training
Intervention Description
Playing computerized stop-signal reactions time tasks that do not change in difficulty level (non-adaptive).
Primary Outcome Measure Information:
Title
Change in Average Parent-Reported Inattention Symptoms
Description
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.
Time Frame
Baseline and 4-weeks
Title
Change in Average Parent-Reported Hyperactivity Symptoms
Description
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.
Time Frame
Baseline and 4-weeks
Secondary Outcome Measure Information:
Title
Change in Relative Theta Power During Resting-State Electroencephalogram(EEG) Recording
Description
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.
Time Frame
Baseline and 4-weeks
Title
Change in Teacher Reported Inattention
Description
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.
Time Frame
Baseline and 4-weeks
Title
Change in Teacher Reported Hyperactivity
Description
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.
Time Frame
Baseline and 4-weeks
Title
Change in N200 Event-Related Potential (ERP) Component During Inhibition
Description
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.
Time Frame
Baseline and 4-weeks
Other Pre-specified Outcome Measures:
Title
Change in NEPSY-II Inhibition Scale Score
Description
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.
Time Frame
Baseline and 4-weeks
Title
Change in Math Ability on the Woodcock Johnson III
Description
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.
Time Frame
Baseline and-4 weeks
Title
Change in Working Memory Capacity
Description
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.
Time Frame
Baseline and 4 weeks
Title
Changes in Inhibitory Control Over Rewarding Stimuli
Description
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.
Time Frame
Baseline and 4 weeks
Title
Changes in Behavior Rating Inventory of Executive Function Global Score
Description
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.
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Sheridan, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Because this is a preliminary study designed primarily to identify feasibility and presence of an effect of this kind of cognitive training on neural and behavioral outcomes in ADHD, we did not develop a data sharing plan. If researchers are interested in working with this data they are encouraged to contact the PI directly - Margaret Sheridan sheridan.margaret@unc.edu
Citations:
PubMed Identifier
9000892
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.
Results Reference
background
PubMed Identifier
11548968
Citation
Nigg JT. Is ADHD a disinhibitory disorder? Psychol Bull. 2001 Sep;127(5):571-98. doi: 10.1037/0033-2909.127.5.571.
Results Reference
background
PubMed Identifier
16135618
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.
Results Reference
background
Citation
Barry, R. J., and Clarke, A. R. (2012) Resting state EEG and symptoms of ADHD. Int. J. Psychophysiol. 85, 294.
Results Reference
background
PubMed Identifier
24120258
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.
Results Reference
background
PubMed Identifier
21432588
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.
Results Reference
background
PubMed Identifier
33253237
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.
Results Reference
derived

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

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