Multi-center, Single Blinded, RCT, Pivotal Study to Evaluate the Efficacy and Safety of DTx to Improve ADHD
NCT07173439, Not applicable, Completed, EMOTIV
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Multi-center, Single Blinded, RCT, Pivotal Study to Evaluate the Efficacy and Safety of DTx to Improve ADHD | ClinicalTrials.gov |
| NCT number | NCT07173439 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 120 participants, actual | ClinicalTrials.gov |
| Lead sponsor | EMOTIV | ClinicalTrials.gov |
| Conditions | ADHD - Attention Deficit Disorder With Hyperactivity, ADHD - Combined Type, ADHD | ClinicalTrials.gov |
| Interventions | Model Name: EMT-SR01;red, Model Name: EMT-SR01;red (Placebo) | ClinicalTrials.gov |
| First posted | 2025-09-15 | ClinicalTrials.gov |
| Last updated | 2025-09-15 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline in ADHD-RS (Investigator-Rated Scale) at end of treatment (FAS) | The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment. | The Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS, Investigator-Rated) is a clinician-administered assessment tool based on the DSM-IV diagnostic criteria for ADHD. It includes 18 items, with 9 items assessing inattention and 9 items assessing hyperactivity/impulsivity. Each item is scored on a 4-point scale (0 = never or rarely, 3 = very often). The total score reflects overall ADHD symptom severity, with higher scores indicating greater severity. The investigator-rated version is completed by a trained clinician through interviews and behavioral observations, rather than by parents or teachers. | ClinicalTrials.gov |
| Secondary | ADHD-RS-IV (Parent-rated, Korean version) | The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment. | The Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV, Parent-rated, Korean version) is a standardized rating scale based on the DSM-IV diagnostic criteria for ADHD. It consists of 18 items corresponding to the inattention (9 items) and hyperactivity/impulsivity (9 items) symptom domains. Parents rate the frequency of each symptom on a 4-point Likert scale ranging from 0 (never or rarely) to 3 (very often). The Korean version has been translated and validated for use in Korean populations. Higher scores indicate greater severity of ADHD symptoms. | ClinicalTrials.gov |
| Secondary | CGI-S(Clinical Global Impression-Severity) | The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment. | The Clinical Global Impression - Severity (CGI-S) scale is a 7-point clinician-rated scale that assesses the clinician's global impression of the patient's current illness severity at the time of evaluation. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). It provides a simple, standardized measure of overall illness severity, independent of specific symptom rating scales. | ClinicalTrials.gov |
| Secondary | CGI-I(Clinical Global Impression-Improvement) | The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment. | The Clinical Global Impression - Improvement (CGI-I) scale is a 7-point clinician-rated scale used to assess how much a patient's illness has improved or worsened relative to baseline. | ClinicalTrials.gov |
| Secondary | CCTT(Children's Color Trails Test) | The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment. | The Children's Color Trails Test (CCTT) is a neuropsychological assessment tool designed to evaluate cognitive functions in children, particularly: * Attention and sustained focus * Cognitive flexibility (set-shifting, task-switching) * Processing speed * Executive functioning | ClinicalTrials.gov |
| Secondary | Stroop | The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment. | The Stroop Test (Stroop Color and Word Test) is a widely used neuropsychological assessment designed to measure attention, selective attention, processing speed, and inhibitory control, which are key aspects of executive function. | ClinicalTrials.gov |
| Secondary | Changes in Medication Dosage | The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment. | Changes in Medication Dosage refers to any adjustments in the dose of a participant's prescribed ADHD medication during the study period. | ClinicalTrials.gov |
| Secondary | Patient-Centered Outcomes | The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment. | Satisfaction (10-point) Participants will rate their overall satisfaction with the intervention on a 10-point Visual Analog Scale (VAS), with higher scores indicating greater satisfaction. Task Difficulty (10-point) Participants will rate the perceived difficulty of the tasks on a 10-point VAS, with higher scores indicating greater difficulty. Suggestions for Improvement (Open-ended) Participants can provide subjective comments or suggestions regarding the intervention. Willingness to Pay (Objective) Participants will indicate their willingness to pay for the intervention using a structured, objective questionnaire. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 42204362 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)