Target ADHD Executive Working Memory Replication Study

Официальное название

Behavioral and Neural Target Engagement for ADHD Executive Working Memory Training

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое Placebo Training
  Computerized tasks with comparable engagement that do not tap executive working memory processes

Первичные конечные точки

• Magnetic Resonance Imaging Functional Brain Scan using a Seimens 3T Skyra. [Срок оценки: Change in fMRI measurements from baseline assessment versus 5 weeks at the conclusion of training]
• Experimental executive working memory training tasks - Reaction Time [Срок оценки: Change in scores from baseline assessment versus 5 weeks at the conclusion of training]
• Experimental executive working memory training tasks - Performance Accuracy [Срок оценки: Change in scores from baseline assessment versus 5 weeks at the conclusion of training]

Вторичные конечные точки (2)

• Conners Rating Scales 3rd Edition [Срок оценки: Change in scores from baseline assessment versus 5 weeks at the conclusion of training]
• Near/Far transfer tasks [Срок оценки: Change in measurements from baseline assessment versus 5 weeks at the conclusion of training.]

Критерии участия

Inclusion Criteriia:

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Institute of Living/Hartford Hospital — Hartford

Идентификаторы

NCT: NCT06446284 · HHC-2023-0178

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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