Prescription digital therapy to treat ADHD appears feasible

A study found statistically significant improvement in ADHD symptoms in children who wore the Revibe Connect device to school, according to a press release.

The results of the study were announced by Revibe Technologies, a digital therapeutics company, on the efficacy of FokusRx, an investigational software as a medical device.

Through a single-arm multi-rater feasibility study, parents and teachers rated schoolchildren aged 8 to 12 years with a parent-reported diagnosis of ADHD, who attended in-person classroom learning without taking medication. To be included, the participants were required to wear the Revibe Connect device to school for at least 3 days per week or a minimum of 15 days total for 4 weeks.

Researchers measured outcomes via the ADHD-RS-5 (Home and School versions), Conners 4 – short version, Weiss Functional Impairment Rating Scale-Parent Form (WFIRS-P) and the Academic Performance Rating Scale (APRS).

Results showed statistically significant improvements in ADHD symptoms measured via the ADHD-RS-5 Total Score from both parents and teachers, four of six domains of functioning (family, school, life skills and social activities) measured via the WFIRS-P and ADHD symptoms (inattention/executive dysfunction, hyperactivity, impulsivity, emotional dysregulation) and functioning (schoolwork, peer relationships, family relationships) measured via the Conners 4 and rated by parents.

Teachers reported statistically significant improvements in academic performance.

"We are pleased that the feasibility study has proven to be a successful exercise that de-risks our upcoming randomized sham-controlled pivotal trial,” Lindsay Ayerst, PhD, chief scientific officer of Revibe, said in the release.

“The moderate to large effect sizes observed and change scores that exceed standards for minimally important (clinically significant) differences, provide encouraging preliminary evidence supporting the efficacy of our intervention.”