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

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

Detailed Description
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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.

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 Adolescents.

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 12-17 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) Undergoing Neurofeedback, cognitive training

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 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 the ADHD Rating Scale (ADHD-RS) parent-report questionnaire | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Behavior Rating Inventory of Executive Function (BRIEF) | 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'). | Baseline, 2-month | 
| Change in Conners' Continuous Performance Test-3 (CPT-3) | 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. | Baseline, 2-month | 
| 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-month | 

 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 treatment, Adolescents