A Novel Device for the Management of ADHD

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

This is a 2-months study, where eligible ADHD adult participants will be provided with personalized VIZO glasses.

Study Overview

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

Detailed Description

This study was designed as a pilot single-center, open-label study of 2 months treatment. 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 Conners Continuous Performance Test-3, the Adult ADHD Self-Report Scale (ASRS), Behavior Rating Inventory of Executive Function Adults (BRIEF-A), and Clinical Global Impression-Improvement (CGI-I) .

• Study Type: Interventional
• Enrollment (Actual): 108
• 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: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Documented history of primary ADHD diagnosis by certified clinicians
• Age 18-40 y
• 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)
• 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
Adult ADHD Self-Report Scale (ASRS) - Total Score at Baseline and 2 Months Follow up	The Adult ADHD Self-Report Scale (ASRS) is a self-report instrument that comprises eighteen items that correspond with the DSM-V-TR criteria for ADHD. Subjects are asked to rate 18 symptom items using a 5-point Likert scale ranging from 0 ('Never') to 4 ('Very Often'). Total scores range from 0 to 72, based on the sum of all 18 questions. Higher scores mean more symptoms and higher ADHD's impairments. Lower values represent better outcomes. The ASRS has two subscales that can be used to identify ADHD subtypes - Inattentiveness and Hyperactivity/Impulsivity. Each subscale contains 9 questions.	Baseline, 2 months
Adult ADHD Self-Report Scale (ASRS) - Inattentiveness Subscale Score at Baseline and 2 Months Follow up	The inattentiveness sub-scale of the ASRS measures difficulties with focusing on details, organisation, remembering appointments, making careless mistakes, and concentration. It includes 9 symptom items using a 5-point Likert scale ranging from 0 ('Never') to 4 ('Very Often'). Total scores range from 0 to 36, based on the sum of all questions. Higher scores mean more symptoms and higher inattentiveness' impairments.	Baseline, 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression-Improvement (CGI-I) - Rate 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 months
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
Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) - Metacognitive Index - at Baseline and 2 Months Follow up	The Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) is a standardized measure that captures views of adults' executive functions or self-regulation in their everyday environment. Items are rated on a 3-points Likert scale of 1 ('Never') to 3 ('Often'). The Metacognition Index (MI) of the BRIEF-A reflects the individual's ability to initiate activity and generate problem-solving ideas, to sustain working memory, to plan and organize problem-solving approaches, to monitor success and failure in problem solving, and to organize one's materials and environment. The MI subscale includes 40-items with score ranges between 40 to 120. Higher values represent worse outcome and greater difficulties with executive functions.	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): March 1, 2023
• Study Completion (Actual): March 26, 2023

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: ADHD; non-pharmacological; 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_003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No