Target ADHD Executive Working Memory Study

Not Applicable

Completed

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

• Registration Number: NCT04795674
• Lead Sponsor: Hartford Hospital

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 Timeline

• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-12
• Study Start: 2021-11-01
• Status Verified: 2023-02
• Primary Completion: 2023-03-19
• Study Completion: 2023-03-19
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The experimental executive working memory training tasks	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.	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.

Trial Locations

Locations (1)

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