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Clinical Trials/NCT04795674
NCT04795674
Completed
Not Applicable

Behavioral and Neural Target Engagement for ADHD Executive Working Memory Training

Hartford Hospital1 site in 1 country62 target enrollmentNovember 1, 2021
ConditionsADHD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ADHD
Sponsor
Hartford Hospital
Enrollment
62
Locations
1
Primary Endpoint
The experimental executive working memory training tasks
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
March 19, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Stevens

Senior Research Scientist

Hartford Hospital

Eligibility Criteria

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

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.

Study Sites (1)

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