Last reviewed · How we verify
NCT07173439
Multi-center, Single Blinded, RCT, Pivotal Study to Evaluate the Efficacy and Safety of DTx to Improve ADHD
NA trial testing Model Name: EMT-SR01;red in ADHD - Attention Deficit Disorder With Hyperactivity in 120 participants. Completed in 13 May 2025.
13 May 2025
Quick facts
| Lead sponsor | EMOTIV |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 15 April 2024 |
| Primary completion | 13 May 2025 |
| Estimated completion | 13 May 2025 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Model Name: EMT-SR01;red
- Model Name: EMT-SR01;red (Placebo)
Conditions studied
- ADHD - Attention Deficit Disorder With Hyperactivity — all drugs for ADHD - Attention Deficit Disorder With Hyperactivity →
- ADHD - Combined Type — all drugs for ADHD - Combined Type →
- ADHD — all drugs for ADHD →
Sponsor
EMOTIV
Who can join
Adults 6 to 12, any sex, with ADHD - Attention Deficit Disorder With Hyperactivity or ADHD - Combined Type. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity, impulsivity, and impaired executive functioning. It typically begins in childhood and is often first diagnosed at school age due to learning and social behavioral difficulties. Therefore, ADHD treatment aims to directly enhance attention, reduce hyperactivity and impulsivity, and ultimately improve task performance and associated behavioral and relational issues. Objective of the Clinical Trial: To evaluate the safety of the investigational digital therapeutic device for the treatment of ADHD. To evaluate the efficacy of the investigational digital therapeutic device for the treatment of ADHD. Study Design \& Methodology: A total of 122 participants were enrolled (62 in the treatment group and 60 in the control group), with 114 participants included in the Full Analysis Set (FAS: 58 treatment, 56 control).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Multicenter randomized trial of a digital therapeutic game for executive function in children with ADHD.
Lee S, Lim YB, Choi W, Park S, et al · · 2026 · PMID 42204362 · DOI 10.1038/s41746-026-02721-3
Verify or expand the search:
- PubMed search for NCT07173439
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for ADHD - Attention Deficit Disorder With Hyperactivity
Currently open trials in the same condition.
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- NCT07139210 — EFFECT OF PERCEPTUAL-MOTOR TRAINING ON COGNITIVE FUNCTIONS, MOTOR ABILITIES AND QUALITY OF LIFE IN CHILDREN WITH ATTENTI · NA · active not recruiting
- NCT06910605 — Exploring Parameters of Driving Simulation in Relation to Drug Holidays in ADHD Patients · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07173439 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by EMOTIV
- Last refreshed: 15 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07173439.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing