Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369714
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-02
Brief Title:
Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children
Sponsor:
Lei Lei MD
Organization:
Changhai Hospital
Study Overview
Official Title:
Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder ADHD in Children
Status:
RECRUITING
Status Verified Date:
2024-04
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:
ADHD
Brief Summary:
A multi-center randomized controlled trial is being conducted to investigate the efficacy of a novel digital therapeutics DTx program that utilizes a cross-training approach between neurofeedback training and executive function training for pediatric patients aged 6-12 diagnosed with ADHD This gamified interactive program is designed to improve attention deficits and executive function impairments in pediatric patients with ADHD It is delivered through an engaging iPad game in a home-based treatment format Patients will be randomly assigned to one of three groups medication alone digital therapeutics alone or a combination of both interventions Subjects will undergo 30 treatment sessions over the 8-week period with each session lasting 30 minutes Investigators will reassess symptoms of ADHD executive functions and objective measures of attention at the end of the treatment Additionally questionnaires will be distributed to parents to gather their insights and feedback on the treatment approach This innovative digital therapeutics approach is expected to improve ADHD symptoms individually and enhance therapeutic outcomes when used alongside conventional drug treatment regimens
Detailed Description:
None
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