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

A Pilot Study to Assess the Efficacy and Safety of a Novel Device (VIZO Glasses) in the Management of ADHD in Adolescents.

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

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Device: VIZO Glasses

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Max Stern Academic College of Emek Yezreel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; VIZO Glasses- personalized	Device: VIZO Glasses; Eyeglasses with personalized peripheral retinal stimuli

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Total Score - at Baseline and 2 Months Follow up	The ADHD-RS is a parent report questionnaire that is used to aid in the diagnosis of ADHD in children ranging from ages 5-17. The questionnaire contains 18 symptom items corresponding to the DSM-V criteria for ADHD. The parent rates each symptom item on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 54. Higher scores mean more symptoms and higher ADHD impairments.	Baseline, 2-month
Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Inattentiveness Subscale - at Baseline and 2 Months Follow up	The Inattention subscale of the ADHD-RS contains 9 symptom items, that are designed to measure the child's attention level on tasks or play activities.The items are rated by the parent on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 27. Higher scores mean more symptoms and higher ADHD impairments.	Baseline, 2-month
Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Hyperactivity-Impulsivity Subscale - at Baseline and 2 Months Follow up	The Hyperactivity-Impulsivity subscale of the ADHD-RS contains 9 symptom items, that are designed to measure the child's hyperactivity level and impulsivity level. The items are rated by the parent on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 27. Higher scores mean more symptoms and higher ADHD impairments.	Baseline, 2-month
Change in Behavior Rating Inventory of Executive Function (BRIEF) - Metacognitive Index - at Baseline and 2 Months Follow up	The Metacognition Index (MI) of the BRIEF reflects a child's ability to self-manage and monitor tasks cognitively. The subscale is composed of the Initiate, Working Memory, Plan/Organize, Organization of Materials, and Monitor scales of the BRIEF. It uses a Likert-type response format ranging from 1 to 3, where 1 is never, 2 is sometimes, and 3 is often. The MI subscale includes 40-items with score ranges between 0 to 120. Higher values represent worse outcome and greater difficulties with executive functions. High scores indicate executive deficit.	Baseline, 2-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression-Improvement (CGI-I) - at 2 Months Follow up	Based on an interview with the participant, the clinician rates the total improvement on a 7 point scale as follows: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.	2-month
Change in Behavior Rating Inventory of Executive Function (BRIEF) - Global Executive Composite - at Baseline and 2 Months Follow up	The BRIEF is a standardized measure that captures views of executive functions or self-regulation in the everyday environment. The BRIEF is composed of 86 items, where each item is rated by the parent, using a 3-point Likert scale ranging from 1 ('Never') to 3 ('Often'). Total score ranges between 86 to 258. The Global Executive Composite (GEC) is an overarching summary score that incorporates all of the BRIEF clinical scales. High scores indicate executive deficit.	Baseline, 2-month
Change in Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up	Conners' Continuous Performance Test-3 (CPT-3) is an objective test of attention and impulsivity that has been validated in individuals aged 8 years and older. d-prime (d') is a measure of how well the respondent discriminates nontargets (i.e., the letter X) from targets (i.e., all other letters). This variable is also a signal detection statistic that measures the difference between the signal (targets) and noise (non-targets) distributions. In general, the greater the difference between the signal and noise distributions, the better the ability to distinguish non-targets and targets. CPT scores are age and gender standardized T-scores, in which the mean is equal to 50 and the standard deviation is equal to 10. d' is reverse-scored so that higher raw score and T-score values indicate worse performance (i.e., poorer discrimination). Atypical scores are higher than 60 indicating "elevated" to "very elevated" performance.	Baseline, 2 months

Collaborators and Investigators

• Sponsor: VIZO Specs Ltd
• Investigators: Principal Investigator: Zohar Elyoseph, PhD, Max Stern Academic College of Emek Yezreel

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): July 6, 2023
• Study Completion (Actual): July 6, 2023

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 9, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Adolescents; ADHD; Non-pharmacological treatment; Peripheral Retinal Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: VIZO_004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No