Target ADHD Executive Working Memory Replication Study
ConditionADHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorHartford Hospital
About this trial
The proposed study will replicate target engagement as assessed in the first phase while also determining if it correlates with clinically meaningful improvements in ADHD dysfunction
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosis of ADHD
English speaking
Right-handed
>5th grade reading level
Disqualifiers
Braces, metal or implant devices
Brain abnormality, neurological disorder
TBI or loss of consciousness>30 minutes
Diagnosis of Psychosis, Bipolar Disorder, ASD, PTSD, OCD, SUD, Tourette's Disorder
Trial design
Design model
Parallel
Treatments tested in this trial
EWM Training
BehavioralTraining tasks will target Executive Working Memory areas of the brain. Task difficulty will be adaptively increased across the 5 weeks of training based on session-to-session performance.
Placebo Training
BehavioralComputerized tasks with comparable engagement that do not tap executive working memory processes
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: ADHD EWMExperimental treatment 1 intervention
Group B: ADHD PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Magnetic Resonance Imaging Functional Brain Scan using a Seimens 3T Skyra.
fMRI measures of brain activation and functional connectivity - Conventional measures of 'brain activation' are estimated using GLM regression models that fit the fMRI BOLD timeseries data to a model of expected hemodynamic change as elicited by fMRI versions of the executive working memory training task trials. Functional connectivity is assessed using a form of cross-correlation analysis that quantifies how much the entire BOLD timeseries in different brain regions are similar to one another. Our a priori treatment target brain regions are the superior frontal sulcus and mid-lateral prefrontal cortex region of interest. Brain activity and functional connectivity specifically to these regions represent the primary outcome measures of the study.
Time frame
Change in fMRI measurements from baseline assessment versus 5 weeks at the conclusion of training2
Experimental executive working memory training tasks - Reaction Time
Reaction time (RT) from training tasks of executive working memory. These are experimental, non-published tasks that were tested in this project for the first time in Phase I: Updating (removal then replacement of stimuli by new information to be maintained in working memory), Shifting (refocusing selective attention on different stimuli held concurrent in working memory without altering contents), distractor Filtering (inhibiting irrelevant information) and Suppression (resolution of proactive interference from initial stimuli to be able to respond optimally to control trials). Trial structure and duration are similar across these tasks. The tasks record RT in milliseconds. Data from active experimental conditions will be log-transformed prior to statistical testing.
Time frame
Change in scores from baseline assessment versus 5 weeks at the conclusion of training3
Experimental executive working memory training tasks - Performance Accuracy
Accuracy (defined as percentage of correct answers from the pool of available items) from training tasks of executive working memory. These are experimental, non-published tasks that were tested in this project for the first time in Phase I: Updating (removal then replacement of stimuli by new information to be maintained in working memory), Shifting (refocusing selective attention on different stimuli held concurrent in working memory without altering contents), distractor Filtering (inhibiting irrelevant information) and Suppression (resolution of proactive interference from initial stimuli to be able to respond optimally to control trials). Trial structure and duration are similar across these tasks. Data from active experimental conditions will be arcsine-transformed prior to statistical testing.
Time frame
Change in scores from baseline assessment versus 5 weeks at the conclusion of trainingSecondary outcomes
1
Conners Rating Scales 3rd Edition
The parent and self-report short forms of the Conners' Rating Scales were designed for repeated and/or brief assessment of symptoms relevant to ADHD and related disorders. Items are measured on a likert scale from 0-3. There are 39 items with total raw scores ranging from 0-117. Higher scores indicate greater severity in ADHD sympotms. This instrument will be used as confirmation of significant association between symptom severity and evidence of target engagement in brain regions.
Time frame
Change in scores from baseline assessment versus 5 weeks at the conclusion of training2
Near/Far transfer tasks
The Near/Far transfer tasks are computer tasks designed by the Principal Investigator to detail common Working Memory processes. They are programmed and adminstered utilizing E-Prime software. The Near Transfer tasks will test the generalizability of Executive Working Memory training outside of trained tasks, and the Far Transfer tasks will test the training effects to other abilities often impaired in ADHD. They are comprised of four categories: Shifting - Refresh/Repeat Task, Updating - Spatial Updating Task, Filtering - Attend-Ignore Task, and Suppression - Introducing Resistance Task
Time frame
Change in measurements from baseline assessment versus 5 weeks at the conclusion of training.Sponsors and contacts
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Source ClinicalTrials.gov