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Behavioural Intervention

FRx-001 for Attention Deficit Hyperactivity Disorder (ADHD)

N/A
Waitlist Available
Research Sponsored by Revibe Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to post-intervention (4 weeks)
Awards & highlights

Summary

This trial is testing three different wearable devices to see if they can help children with ADHD improve their focus and behavior at school. The children will wear these devices for a period of time, and their progress will be monitored by parents and teachers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to post-intervention (4 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to post-intervention (4 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ADHD Rating Scale-5 (ADHD-RS-5), School Version: Inattention Subscale
Secondary study objectives
ADHD Rating Scale-5, Home Version: Inattention Subscale
ADHD Rating Scale-5, Home Version: Total score
ADHD Rating Scale-5, School Version: Total score
Other study objectives
ADHD Rating Scale-5, Home Version: Hyperactivity-Impulsivity Subscale
ADHD Rating Scale-5, School Version: Hyperactivity-Impulsivity Subscale
Academic Performance Rating Scale
+7 more

Trial Design

3Treatment groups
Active Control
Group I: FRx-001Active Control1 Intervention
FRx-001 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and scheduled assistive messaging.
Group II: FRx-003Active Control1 Intervention
FRx-003 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and may include periodic assistive messaging.
Group III: FRx-004Active Control1 Intervention
FRx-004 is a wearable digital intervention that displays periodic therapeutic assistive messaging.

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Who is running the clinical trial?

Revibe TechnologiesLead Sponsor
~38 spots leftby Sep 2025
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