Target ADHD Executive Working Memory Replication Study

NCT06446284 | Recruiting

• 1 other identifier: HHC-2023-0178
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Conditions

ADHD

Outcome Measures

Primary Outcomes (3)

• 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

• Experimental executive working memory training tasks - Reaction Time

  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.

  Change in scores from baseline assessment versus 5 weeks at the conclusion of training

• Experimental executive working memory training tasks - Performance Accuracy

  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.

  Change in scores from baseline assessment versus 5 weeks at the conclusion of training

Secondary Outcomes (2)

• Conners Rating Scales 3rd Edition

  Change in scores from baseline assessment versus 5 weeks at the conclusion of training

• Near/Far transfer tasks

  Change in measurements 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: Yes
• Age Groups: Child (0-17), Adult (18-64)

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

RECRUITING

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

Central Study Contacts

Karen L Kesten, MS

CONTACT

8605457776; Karen.kesten@hhchealth.org

Abigail Sullivan, MS

CONTACT

8605457363; Abigail.sullivan@hhchhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: June 6, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)