A Pilot Study to Assess the Efficacy and Safety of a Novel Device (VIZO Glasses) in the Management of ADHD in Adolescents.
Phase: NA
Conditions: ADHD
Sponsor: VIZO Specs Ltd

Date: February 1st, 2022 
 
Study Protocol and Statistical Analysis Plan 
 
Study Title 
 
A Novel, Non-pharmacological, Intervention for the 
Management of ADHD in Adolescents 
 
Protocol ID 
VIZO_004 
ClinicalTrials.gov ID 
NCT05835336 
 

Protocol Synopsis 
VIZO_004 
 
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Device Name 
VIZO Glasses 
Objectives 
To Assess the Efficacy and Safety of a Novel Device (VIZO 
Glasses) in the Management of ADHD in Adolescents.  
 
Study Group 
Investigational Group 
VIZO Glasses:  Eyeglasses with personalized peripheral retinal 
stimuli 
Key Eligibility Criteria 
 
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 
• Any other reason that, in the opinion of the investigator, 
prevents the participant from participating in the study  
 
Endpoints 
 
Primary 
Primary Outcome Measure: 
Change in the ADHD Rating Scale (ADHD-RS) Parent-report 
Questionnaire - Total Score   [Time Frame: Baseline, 2-
month] 
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. 
 
 
Change in the ADHD Rating Scale (ADHD-RS) Parent-report 
Questionnaire - Inattention Subscale   [Time Frame: Baseline, 
2-month] 
The Inattention subscale of the ADHD-RS contains 9 symptom 

Protocol Synopsis 
VIZO_004 
 
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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. 
 
Change in the ADHD Rating Scale (ADHD-RS) Parent-report 
Questionnaire - Hyperactivity-Impulsivity Subscale   [Time 
Frame: Baseline, 2-month] 
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. 
 
 
Change in Behavior Rating Inventory of Executive Function 
(BRIEF) - Metacognitive Index   [Time Frame: Baseline, 2-
month] 
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. 
High scores indicate executive deficit. 
Secondary 
Secondary Outcome Measures: 
Clinical Global Impression-Improvement (CGI-I)   [Time 
Frame: 2-month] 
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. 
 
 
Change in Behavior Rating Inventory of Executive Function 
(BRIEF) - Global Executive Composite   [Time Frame: Baseline, 
2-month] 
The BRIEF is a standardized measure that captures views of 

Protocol Synopsis 
VIZO_004 
 
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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'). The Global Executive 
Composite (GEC) is an overarching summary score that 
incorporates all of the BRIEF clinical scales. High scores 
indicate executive deficit. 
Other Outcomes 
Adverse events will be monitored and documented. 
Follow-up Visits Schedule 
This was a two-month, open-label study in which eligible ADHD-
diagnosed adolescents were provided with a pair of VIZO-
Glasses featuring a personalized visual stimuli pattern for each 
participant. A baseline assessment of the participants’ ADHD 
clinical profile pre-intervention included the ADHD-RS and the 
Behavior Rating Inventory of Executive Function (BRIEF) 
questionnaires. In addition, participants completed the 
Conners’ Continuous Performance Test-3 (CPT-3). Optical 
centration parameters and demographic information were 
collected for each participant. Participants were then invited to 
complete a personalization process in which they were fitted 
with personalized VIZO-glasses. Participants were instructed to 
wear their Vizo-glasses for at least two hours daily for two 
months. A follow-up assessment at the end of the intervention 
re-assessed ADHD performance on the ADHD-RS and BRIEF 
questionaries. In addition, participants completed the CPT-3 
test while wearing their VIZO-glasses. The Clinical Global 
Impression-Improvement (CGI-I) rating scale was administered 
by a clinician.   
Sample Size 
Given the exploratory nature of the study, the sample size was 
chosen to be sufficiently large to detect significant within 
subject effects of at least 0.5 (Cohen's D) for a 2-Tailed test, at 
anlpha-0.05 with a power of 80%. 
Analysis Plan 
Paired samples t-tests will be used to test the effect of the 
VIZO-glasses intervention, comparing the baseline and end-of-
intervention performances. No corrections for multiple testing 
will be applied due to the exploratory nature of the study. The 
safety analysis will include all available data on the intent-to-
treat (ITT) population.