Status:
COMPLETED
Multi-center, Single Blinded, RCT, Pivotal Study to Evaluate the Efficacy and Safety of DTx to Improve ADHD
Lead Sponsor:
EMOTIV
Conditions:
ADHD - Attention Deficit Disorder With Hyperactivity
ADHD - Combined Type
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
Background: Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity, impulsivity, and impaired executive functioning. It typically...
Detailed Description
Expanded Clinical Summary: Investigational Digital Therapeutic Device for ADHD \[Background and Rationale\] Attention-Deficit/Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characteri...
Eligibility Criteria
Inclusion
- Subjects must meet all the following inclusion criteria:
- Children and adolescents aged 6 years or older but under 13 years, both male and female.
- Diagnosed with ADHD according to DSM-5 criteria or ICD-10 diagnosis of ADHD (F90.0).
- K-ARS scores of 18 or higher for females and 22 or higher for males.
- No changes in ADHD medication dosage or regimen within 1 month prior to enrollment (\*For those receiving pharmacological treatment with methylphenidate or amphetamine-based products, a washout period of 14 days is required if they wish to participate after discontinuing medication).
- Medically healthy based on medical history and vital signs assessed during screening, without other medical abnormalities.
- Able to use a smartphone or tablet PC that meets specified requirements to operate the mobile application without difficulty.
- Both the subject and their guardian voluntarily agree to participate and provide written informed consent.
Exclusion
- Subjects will be excluded if they meet any of the following criteria:
- Presence of any of the following psychiatric symptoms at baseline: chronic tic disorder (requiring medication), Tourette's disorder, or history of major obsessive-compulsive disorder, schizophrenia, bipolar disorder, post-traumatic stress disorder, conduct disorder, or other childhood psychosis (affective disorders are not exclusionary).
- Wechsler Intelligence Scale for Children (WISC) score below 80.
- Presence of congenital genetic disorders.
- Uncontrolled or severe systemic physical illness requiring hospitalization at baseline.
- Suicide attempt within the past 3 months and assessed as high suicide risk by a psychiatrist.
- Initiation or ongoing other cognitive behavioral therapy within the past 3 months (including any CBT for ADHD or other conditions, based on insurance coverage).
- Presence of visual, auditory, or cognitive impairments.
- Any other reasons deemed by the investigator to make the subject unsuitable for participation in the clinical trial.
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07173439
Start Date
April 15 2024
End Date
May 13 2025
Last Update
September 15 2025
Active Locations (1)
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1
Emotiv
Seoul, gangnam, South Korea, 06179