A Novel Device for the Management of ADHD

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

Detailed Description
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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) .

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

Conditions
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ADHD

Intervention / Treatment
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* Device: VIZO Glasses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>VIZO Glasses- personalized | Device: VIZO Glasses<br>* Eyeglasses with personalized peripheral retinal stimuli<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Adult ADHD Self-Report Scale (ASRS) | The ASRS is a self-report instrument that comprises eighteen items that correspond with the DSM-V-TR criteria for ADHD. The ASRS-Self is a subject-administered instrument and subjects rate 18 symptom items using a 5-point Likert scale ranging from 0 ('Never') to 4 ('Very Often'). The total score goes from 0 up to 72. Higher scores mean more symptoms and higher ADHD's impairments. | Baseline, 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression-Improvement (CGI-I) | 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 | 
| Change in Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') | 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. On the Conners CPT 3, d' is reverse-scored so that higher raw score and T-score values indicate worse performance (i.e., poorer discrimination). | Baseline, 2 months | 
| Change in Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) | The BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment. The BRIEF-A is composed of 75 items and each item is rated by subjects using a 3-point Likert scale ranging from 1 ('Never') to 3 ('Often'). | Baseline, 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Peripheral Retinal Stimulation, non-pharmacological