Assessing a Wearable Digital Therapy for Youth With 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

97 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How does the drug FRx-001, FRx-003, FRx-004 differ from other treatments for fragile X syndrome?

The drug FRx-001, FRx-003, FRx-004 may target the underlying genetic mechanisms of fragile X syndrome by focusing on the fragile X mental retardation protein (FMRP) and its RNA targets, which are implicated in the condition. This approach is unique as it potentially addresses the root cause of the syndrome rather than just alleviating symptoms. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

Interventions

• FRx-001
• FRx-003
• FRx-004

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Clustering of two fragile sites and seven homeobox genes in human chromosome region 2q31-->q32.1. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Closely linked cis-acting modifier of expansion of the CGG repeat in high risk FMR1 haplotypes. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Tissue and developmental regulation of fragile X mental retardation 1 exon 12 and 15 isoforms. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Analysis of FMRP mRNA target datasets reveals highly associated mRNAs mediated by G-quadruplex structures formed via clustered WGGA sequences. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Linkage analysis of the fragile X syndrome using a new DNA marker U6.2 defining locus DXS304. [2019]