Behavioral and Neural Target Engagement for ADHD Executive Working Memory Training
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hartford Hospital
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- The experimental executive working memory training tasks
Study Overview
Brief Summary
This study will assess whether or not a novel executive working memory training intervention for Attention-Deficit/Hyperactivity Disorder can engage frontoparietal brain network treatment targets and behavioral performance.
Detailed Description
This proposal seeks support for a 2-year milestone-driven R61 initial test of target engagement in n=62 ADHD diagnosed adolescents randomized to a 'sham training' placebo or to train 4 times each week using 4 different EWM exercises that have been combined into the format of a typical cognitive training intervention. Exercise difficulty levels in the active intervention will increase across 5 weeks to continually challenge EWM ability. EWM training will use a novel, remotely-supervised 'at home' computerized training approach. If R61 EWM training target engagement milestones are met, a 3-year R33 phase will begin. The R33 will replicate target engagement in another randomized placebo-controlled trial of n=90 new ADHD adolescents and attempt to establish a convincing link between the hypothesized targets and ADHD symptom expression. It also will characterize ADHD brain activity or EWM ability changes relative to typical levels seen in an n=40 non-ADHD control group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 12 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of ADHD
- •English speaking
- •Right-handed
- •>5th grade reading level
- •>80 IQ level
Exclusion Criteria
- •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
Arms & Interventions
ADHD EWM
Participants will receive EWM training sessions.
Intervention: EWM Training (Behavioral)
ADHD Placebo
Participants will receive placebo training sessions.
Intervention: Placebo Training (Behavioral)
Outcomes
Primary Outcomes
The experimental executive working memory training tasks
Time Frame: Change in scores from baseline assessment versus 5 weeks at the conclusion of training
Will examine changes in performance accuracy on the 4 executive working memory training tasks. These are experimental, non-published tasks being tested in this project for the first time.
Magnetic Resonance Imaging Functional Brain Scan using a Seimens 3T Skyra.
Time Frame: Change in fMRI measurements from baseline assessment versus 5 weeks at the conclusion of training
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Michael Stevens
Senior Research Scientist
Hartford Hospital