Clinical trial NCT06446284: Target ADHD Executive Working Memory Replication Study
Official title: Behavioral and Neural Target Engagement for ADHD Executive Working Memory Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 130
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This proposal is a 3-year clinical trial study replicating an R61 study that targeted brain engagement in 62 ADHD diagnosed adolescents. This study will recruit n=130 adolescents, n=90 ADHD, 40 non-ADHD. The ADHD group will be 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 that was developed in the Phase I study. This study will attempt to establish a convincing link between the hypothesized targets found in Phase I and ADHD symptom expression. It also will characterize ADHD brain activity or EWM ability changes relative to typical levels seen in the n=40 non-ADHD control group.

Eligibility criteria: Inclusion Criteriia:

* 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

Primary outcomes:
measure: Magnetic Resonance Imaging Functional Brain Scan using a Seimens 3T Skyra.
timeFrame: Change in fMRI measurements from baseline assessment versus 5 weeks at the conclusion of training
measure: Experimental executive working memory training tasks - Reaction Time
timeFrame: Change in scores from baseline assessment versus 5 weeks at the conclusion of training
measure: Experimental executive working memory training tasks - Performance Accuracy
timeFrame: Change in scores from baseline assessment versus 5 weeks at the conclusion of training
Secondary outcomes:
measure: Conners Rating Scales 3rd Edition
timeFrame: Change in scores from baseline assessment versus 5 weeks at the conclusion of training
measure: Near/Far transfer tasks
timeFrame: Change in measurements from baseline assessment versus 5 weeks at the conclusion of training.
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Institute of Living/Hartford Hospital
state: Connecticut
Study officials:
affiliation: Institute of Living/Hartford Hospital
name: Michael C Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
References: