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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05777785
Enrollment
108
Registered
2023-03-21
Start date
2022-04-01
Completion date
2023-03-26
Last updated
2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

ADHD, Peripheral Retinal Stimulation, non-pharmacological

Brief summary

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

Interventions

Eyeglasses with personalized peripheral retinal stimuli

Sponsors

VIZO Specs Ltd
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adult ADHD Self-Report Scale (ASRS) - Total Score at Baseline and 2 Months Follow upBaseline, 2 monthsThe 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.
Adult ADHD Self-Report Scale (ASRS) - Inattentiveness Subscale Score at Baseline and 2 Months Follow upBaseline, 2 monthsThe 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.

Secondary

MeasureTime frameDescription
Clinical Global Impression-Improvement (CGI-I) - Rate at 2 Months Follow up2 monthsBased 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.
Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow upBaseline, 2 monthsConners' 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.
Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) - Metacognitive Index - at Baseline and 2 Months Follow upBaseline, 2 monthsThe 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.

Countries

Israel

Participant flow

Pre-assignment details

108 partcipants met the inclusion criteria. Two participants failed to comply with the personalization process due to difficulty staying awake or using a cell phone during the test, resulting in 106 participants receiving the intervention.

Participants by arm

ArmCount
Active
VIZO Glasses- personalized VIZO Glasses: Eyeglasses with personalized peripheral retinal stimuli. Participants were instructed to wear the glasses throughout the day for two months.
97
Total97

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up1
Overall StudyWithdrawal by Subject5

Baseline characteristics

CharacteristicActive
Adult ADHD Self-Report Scale (ASRS) - Hyperactivity/Impulsivity subscale18.56 units on a scale
STANDARD_DEVIATION 6.64
Adult ADHD Self-Report Scale (ASRS) - Inattentiveness Subscale21.2 units on a scale
STANDARD_DEVIATION 6.68
Adult ADHD Self-Report Scale (ASRS) - Total Score39.76 units on a scale
STANDARD_DEVIATION 12.1
Age, Continuous26.51 years
STANDARD_DEVIATION 4.59
Race and Ethnicity Not Collected— Participants
Sex: Female, Male
Female
51 Participants
Sex: Female, Male
Male
46 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 100
other
Total, other adverse events
64 / 100
serious
Total, serious adverse events
0 / 100

Outcome results

Primary

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.

Time frame: Baseline, 2 months

Population: Two participants did not complete the questionnaire.

ArmMeasureGroupValue (MEAN)Dispersion
ActiveAdult ADHD Self-Report Scale (ASRS) - Inattentiveness Subscale Score at Baseline and 2 Months Follow upBaseline21.20 score on a scaleStandard Error 0.69
ActiveAdult ADHD Self-Report Scale (ASRS) - Inattentiveness Subscale Score at Baseline and 2 Months Follow upEnd of study20.22 score on a scaleStandard Error 0.72
p-value: 0.037t-test, 2 sided
Primary

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.

Time frame: Baseline, 2 months

Population: Two participants did not complete the questionnaire.

ArmMeasureGroupValue (MEAN)Dispersion
ActiveAdult ADHD Self-Report Scale (ASRS) - Total Score at Baseline and 2 Months Follow upBaseline39.76 score on a scaleStandard Error 1.24
ActiveAdult ADHD Self-Report Scale (ASRS) - Total Score at Baseline and 2 Months Follow upEnd of study38.27 score on a scaleStandard Error 1.31
Secondary

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.

Time frame: Baseline, 2 months

Population: Four participants did not complete the questionnaire.

ArmMeasureGroupValue (MEAN)Dispersion
ActiveBehavior Rating Inventory of Executive Function Adult Version (BRIEF-A) - Metacognitive Index - at Baseline and 2 Months Follow upBaseline79.85 score on a scale (raw scores)Standard Error 1.75
ActiveBehavior Rating Inventory of Executive Function Adult Version (BRIEF-A) - Metacognitive Index - at Baseline and 2 Months Follow upEnd of Study77.76 score on a scale (raw scores)Standard Error 1.75
p-value: 0.029t-test, 2 sided
Secondary

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.

Time frame: 2 months

Population: Nine participants did not participate in the clinicial interview.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
ActiveClinical Global Impression-Improvement (CGI-I) - Rate at 2 Months Follow upCGI-I score of 1, 2 or 377 Participants
ActiveClinical Global Impression-Improvement (CGI-I) - Rate at 2 Months Follow upCGI-I score of 4 or higher11 Participants
Secondary

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.

Time frame: Baseline, 2 months

Population: Four participants did not complete the CPT.

ArmMeasureGroupValue (MEAN)Dispersion
ActiveConners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow upBaseline50.03 T-scoreStandard Error 0.9
ActiveConners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow upEnd of Study47.95 T-scoreStandard Error 1.06
p-value: 0.027t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026