A Novel, Non-pharmacological, Intervention for the Management of ADHD in Adolescents

Last updated: March 9, 2025
Sponsor: VIZO Specs Ltd
Overall Status: Completed

Phase

N/A

Condition

Williams Syndrome

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Treatment

VIZO Glasses

Clinical Study ID

NCT05835336
VIZO_004
  • Ages 12-17
  • All Genders

Study Summary

This is a 2-month study in which eligible ADHD adolescents will be provided with personalized VIZO Glasses

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented history of primary ADHD diagnosis by certified clinicians

  • Age 12-17 y

  • Minimum total of 24 on the parent ADHD-IV Rating Scale (ADHD-RS)

  • Written informed consent

  • Able and willing to complete all required ratings and assessments

Exclusion

Exclusion Criteria:

  • Any current psychiatric/neurological comorbidity (e.g., epilepsy, Autism,depression, TBI, etc.), other than ADHD

  • ADHD Medications (stimulants, non-stimulants, other)

  • Undergoing Neurofeedback, cognitive training

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: VIZO Glasses
Phase:
Study Start date:
April 01, 2022
Estimated Completion Date:
July 06, 2023

Study Description

This is a pilot, open-label study of a 2-month treatment with VIZO Glasses. Following the enrollment, the participants will go through an adjustment process where they will be fitted with a personalized pair of VIZO Glasses. The participants will be instructed to wear the glasses throughout the day for two months. A follow-up visit at the end of the 2-month treatment will be conducted to assess the efficacy of VIZO Glasses on managing ADHD symptoms, using the ADHD Rating Scale (ADHD-RS) parent-report questionnaire, the Behavior Rating Inventory of Executive Function (BRIEF), the Conners Continuous Performance Test-3, and the Clinical Global Impression-Improvement (CGI-I). Safety will be monitored by documentation of adverse events.

Connect with a study center

  • Max Stern Academic College of Emek Yezreel

    Haifa,
    Israel

    Site Not Available

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