Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446284
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-02-26
Brief Title:
Target ADHD Executive Working Memory Replication Study
Sponsor:
Hartford Hospital
Organization:
Hartford Hospital
Study Overview
Official Title:
Behavioral and Neural Target Engagement for ADHD Executive Working Memory Training
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n130 adolescents n90 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 n40 non-ADHD control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None