Target ADHD Executive Working Memory Study

Sponsor

Hartford Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04795674

Collaborator

(none)

Enrollment

Location

Arms

22.4

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ADHD	Behavioral: EWM Training Behavioral: Placebo Training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Behavioral and Neural Target Engagement for ADHD Executive Working Memory Training

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Sep 15, 2023

Anticipated Study Completion Date :

Sep 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ADHD EWM Participants will receive EWM training sessions.	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 Comparator: ADHD Placebo Participants will receive placebo training sessions.	Behavioral: Placebo Training Computerized tasks with comparable engagement that do not tap executive working memory processes

Arm

Intervention/Treatment

Experimental: ADHD EWM

Participants will receive EWM training sessions.

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 Comparator: ADHD Placebo

Participants will receive placebo training sessions.

Behavioral: Placebo Training

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

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Living/Hartford Hospital	Hartford	Connecticut	United States	06106

Sponsors and Collaborators

Hartford Hospital

Investigators

Principal Investigator: Michael C Stevens, PhD, Institute of Living/Hartford Hospital

Study Documents (Full-Text)

Informed Consent Form - Nov 25, 2020

More Information

Publications

None provided.

Responsible Party:

Michael Stevens, Senior Research Scientist, Hartford Hospital

ClinicalTrials.gov Identifier:

NCT04795674

Other Study ID Numbers:

HHC-2020-0305

First Posted:

Mar 12, 2021

Last Update Posted:

Jan 31, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Michael Stevens, Senior Research Scientist, Hartford Hospital

Adolescents

Study Results

No Results Posted as of Jan 31, 2022