Target ADHD Executive Working Memory Study

NCT04795674 | Completed

• 1 other identifier: HHC-2020-0305
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

Adolescents

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

ADHD EWM

EXPERIMENTAL

Participants will receive EWM training sessions.

Behavioral: EWM Training

ADHD Placebo

PLACEBO COMPARATOR

Participants will receive placebo training sessions.

Behavioral: Placebo Training

Interventions

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.

ADHD EWM

Placebo Training BEHAVIORAL

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

ADHD Placebo

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of ADHD
• English speaking
• Right-handed
• \>5th grade reading level
• \>80 IQ level

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Institute of Living/Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Michael C Stevens, PhD

  Institute of Living/Hartford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 12, 2021
• Study Start: November 1, 2021
• Primary Completion: March 19, 2023
• Study Completion: March 19, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)