Target ADHD Executive Working Memory Study

ADHD Clinical Trial

Official title:

Behavioral and Neural Target Engagement for ADHD Executive Working Memory Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04795674
• Other study ID #: HHC-2020-0305
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: March 19, 2023

Study information

• Verified date: February 2023
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 19, 2023
• Est. primary completion date: March 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• EWM Training
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
Computerized tasks with comparable engagement that do not tap executive working memory processes

Locations

Country	Name	City	State
United States	Institute of Living/Hartford Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnetic Resonance Imaging Functional Brain Scan using a Seimens 3T Skyra.	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.	Change in fMRI measurements from baseline assessment versus 5 weeks at the conclusion of training
Primary	The experimental executive working memory training tasks	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.	Change in scores from baseline assessment versus 5 weeks at the conclusion of training