Wearable Digital Therapy for ADHD

Overseen By Lindsay E Ayearst, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Revibe Technologies

Must be taking: ADHD medications

Disqualifiers: Autism, Intellectual disability, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test three wearable digital devices—FRx-001, FRx-003, and FRx-004—to determine if they help children with ADHD (Attention-Deficit/Hyperactivity Disorder) improve symptoms and daily functioning. Worn on the wrist, these devices may provide therapeutic vibrations or assistive messages to manage ADHD symptoms. Children diagnosed with ADHD, attending in-person school, and able to wear the device for four weeks are suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity for children to potentially benefit from innovative technology designed to improve ADHD management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that participants have been undergoing pharmacological treatment for ADHD in the past 30 days.

What prior data suggests that these wearable digital interventions are safe for children with ADHD?

Research has shown that wearable digital devices are generally safe for use. For example, past studies on devices like FRx-001 found them to be well-tolerated. These devices track health information without causing harm. Similarly, FRx-003 underwent testing in various situations and revealed no major safety issues. It gathers health data and has been used safely in other areas. Additionally, FRx-004, another wearable device, participated in studies that found it aids physical activity without causing problems.

While these devices are new treatments for ADHD, their design and technology have been safely used in other fields. Prospective trial participants might find reassurance in the safety record of these wearables from other studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for ADHD because they offer a new, non-invasive approach using wearable digital technology. Unlike traditional medications like stimulants or non-stimulants, which target neurotransmitters in the brain, these devices focus on delivering therapeutic vibrations and assistive messaging directly to the wrist. FRx-001 and FRx-003 provide therapeutic vibrations, with FRx-001 offering scheduled messaging and FRx-003 potentially including periodic messaging. Meanwhile, FRx-004 focuses solely on displaying therapeutic assistive messaging. This innovative method could provide a more engaging and accessible option for youth, potentially reducing the need for medication and its associated side effects.

What evidence suggests that this trial's wearable digital interventions could be effective for ADHD?

Research shows that wearable digital tools can improve behaviors and outcomes in children with conditions like ADHD. In this trial, participants may receive one of the following interventions: FRx-001, FRx-003, or FRx-004. Studies have found that wearable devices using therapeutic vibrations, such as FRx-001 and FRx-003, can enhance social behavior in children with autism. This suggests they might also help with ADHD, as both conditions involve attention and behavior issues. Meanwhile, FRx-004 uses assistive messaging, and evidence indicates that digital messages can manage symptoms by providing timely reminders and support. Although specific data for ADHD is limited, positive results in similar conditions suggest these devices could be beneficial. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

The study does not include children or teenagers.

You must be between 8 and 12 years old.

You must be a resident of the United States.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Online screening questionnaire

Baseline Assessment

Parents and teachers complete baseline measures

1 week

Remote assessments

Treatment

Children wear the assigned device to school Monday-Friday for a four-week period

4 weeks

Remote monitoring of device compliance

Post-intervention Assessment

Parents and teachers complete measures again at the end of the four-week intervention period

1 week

Remote assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FRx-001
• FRx-003
• FRx-004

How Is the Trial Designed?

Group I: FRx-001 Active Control 1 Intervention

FRx-001 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and scheduled assistive messaging.

Group II: FRx-003 Active Control 1 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-004 Active Control 1 Intervention

FRx-004 is a wearable digital intervention that displays periodic therapeutic assistive messaging.

Who Is Running the Clinical Trial?

Revibe Technologies

Lead Sponsor

Trials

1

Recruited

100+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30907929/

Effect of Wearable Digital Intervention for Improving ... - PubMed This is the first randomized clinical trial to demonstrate efficacy of a wearable digital intervention to improve social behavior of children with ASD.

2. researchgate.net researchgate.net/publication/349854980_Focal_Vibration_Therapy_Vibration_Parameters_of_Effective_Wearable_Devices

Vibration Parameters of Effective Wearable Devices When the devices were strapped to the body (constrained), vibration amplitude decreased by up to 65.7%. These results identify effective ranges ...

3. hamr.lcsr.jhu.edu hamr.lcsr.jhu.edu/wp-content/uploads/2025/07/CARDUCCI-DISSERTATION-2023.pdf

DEVICE CHARACTERIZATION FOR HUMAN HAND AND WRIST ... Current therapy tools have limited clinical outcomes for upper-limb recovery due to incomplete models of hand and wrist function that in turn inform device ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6503634/

Effect of Wearable Digital Intervention for Improving ... This randomized clinical trial evaluates the efficacy of a wearable behavioral intervention for improving social outcomes of children with autism spectrum ...

5. mdpi.com mdpi.com/2076-3417/14/14/6323

AI, BlazePod Sensors, and Head Vests Implemented in ... The Flash Reflex (FRX) Training methodology utilizes BlazePod's Pods and app to enhance users' reactive intelligence, aiming to improve cognitive and physical ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&event_id=&productdescriptiontxt=hil&productcode=&IVDProducts=&rootCauseText=&recallstatus=&centerclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=07%2F10%2F2014&productshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=&knumber=&PAGENUM=500

Medical Device Recalls - accessdata.fda.gov Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Syste...139, 2, 01/04/2013, Philips Medical ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9987377/

Wearable device and smartphone data quantify ALS ... Several wearable data daily physical activity measures demonstrated statistically significant change over time and associations with ALSFRS-RSE ...

8. researchgate.net researchgate.net/publication/330338193_Evaluation_of_Wearable_Digital_Devices_in_a_Phase_I_Clinical_Trial

(PDF) Evaluation of Wearable Digital Devices in a Phase I ... PDF | We assessed the performance of two US Food and Drug Administration (FDA) 510(k)‐cleared wearable digital devices and the operational feasibility.

9. dannydid.org dannydid.org/wp-content/uploads/Tobi_etc_Epilepsia_2021.pdf

Wearable Devices for Seizure Detection: Practical ... Live data streaming is also a key requirement for any intervention or alarm system not directly built into the wearable device. Page 6. 6 |.

10. link.springer.com link.springer.com/content/pdf/10.1631/FITEE.2100085.pdf

Wearable devices and IoT applications for symptom ... Here we explore innovative wearable solutions. (reported in scientific works) that are aimed at detecting the onset of the first symptoms of. COVID-19, such as ...