Target ADHD Executive Working Memory Replication Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EWM Training, Placebo Training.
- Who it may be relevant to
- Registry conditions: ADHD. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Behavioral and Neural Target Engagement for ADHD Executive Working Memory Training
Overview
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.
Interventions
- 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. - Behavioral Placebo Training
Computerized tasks with comparable engagement that do not tap executive working memory processes
Primary outcome measures
- Magnetic Resonance Imaging Functional Brain Scan using a Seimens 3T Skyra. [Time frame: Change in fMRI measurements from baseline assessment versus 5 weeks at the conclusion of training]
- Experimental executive working memory training tasks - Reaction Time [Time frame: Change in scores from baseline assessment versus 5 weeks at the conclusion of training]
- Experimental executive working memory training tasks - Performance Accuracy [Time frame: Change in scores from baseline assessment versus 5 weeks at the conclusion of training]
Secondary outcome measures (2)
- Conners Rating Scales 3rd Edition [Time frame: Change in scores from baseline assessment versus 5 weeks at the conclusion of training]
- Near/Far transfer tasks [Time frame: Change in measurements from baseline assessment versus 5 weeks at the conclusion of training.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Institute of Living/Hartford Hospital — Hartford
Identifiers
NCT: NCT06446284 · HHC-2023-0178