Target ADHD Executive Working Memory Replication Study

Not Applicable

Recruiting

• Conditions: ADHD
• Interventions: Behavioral: EWM Training; Behavioral: Placebo Training

• Registration Number: NCT06446284
• Lead Sponsor: Hartford Hospital

Brief Summary

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

Detailed Description

This proposal is a 3-year clinical trial study replicating an R61 study that targeted brain engagement in 62 ADHD diagnosed adolescents. This study will recruit n=130 adolescents, n=90 ADHD, 40 non-ADHD. The ADHD group will be 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 that was developed in the Phase I study. This study will attempt to establish a convincing link between the hypothesized targets found in Phase I and ADHD symptom expression. It also will characterize ADHD brain activity or EWM ability changes relative to typical levels seen in the n=40 non-ADHD control group.

Study Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2024-02-26
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-04
• Last Update Submitted: 2024-06-04
• Study First Posted: 2024-06-06
• Last Update Posted: 2024-06-06
• Primary Completion: 2026-08-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADHD EWM	EWM Training	Participants will receive EWM training sessions.
ADHD Placebo	Placebo Training	Participants will receive placebo training sessions.

Primary Outcome Measures

Name	Time	Method
Experimental executive working memory training tasks - Reaction Time	Change in scores from baseline assessment versus 5 weeks at the conclusion of training	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.
Magnetic Resonance Imaging Functional Brain Scan using a Seimens 3T Skyra.	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.
Experimental executive working memory training tasks - Performance Accuracy	Change in scores from baseline assessment versus 5 weeks at the conclusion of training	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.

Secondary Outcome Measures

Name	Time	Method
Conners Rating Scales 3rd Edition	Change in scores from baseline assessment versus 5 weeks at the conclusion of training	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.
Near/Far transfer tasks	Change in measurements from baseline assessment versus 5 weeks at the conclusion of training.	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

Trial Locations

Locations (1)

Institute of Living/Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States