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Completed

NCT Number: NCT04795674

Target ADHD Executive Working Memory Study

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Living/Hartford Hospital

Hartford, Connecticut, 06106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EWM Training

Behavioral

Training 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

Behavioral

Computerized tasks with comparable engagement that do not tap executive working memory processes

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Registry information

Official study title

Behavioral and Neural Target Engagement for ADHD Executive Working Memory Training

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2021
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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