Target ADHD Executive Working Memory Replication Study
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About
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
Full 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.
Enrollment
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Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
130 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Karen L Kesten, MS; Abigail Sullivan, MS
Data sourced from clinicaltrials.gov
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