A Novel, Non-pharmacological, Intervention for the Management of ADHD in Adolescents
Study Details
Study Description
Brief Summary
This is a 2-month study in which eligible ADHD adolescents will be provided with personalized VIZO Glasses
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active VIZO Glasses- personalized |
Device: VIZO Glasses
Eyeglasses with personalized peripheral retinal stimuli
|
Outcome Measures
Primary Outcome Measures
- Change in the ADHD Rating Scale (ADHD-RS) parent-report questionnaire [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.
Secondary Outcome Measures
- Change in Behavior Rating Inventory of Executive Function (BRIEF) [Baseline, 2-month]
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').
- Change in Conners' Continuous Performance Test-3 (CPT-3) [Baseline, 2-month]
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.
- Clinical Global Impression-Improvement (CGI-I) [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Documented history of primary ADHD diagnosis by certified clinicians
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Age 12-17 y
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Written informed consent
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Able and willing to complete all required ratings and assessments
Exclusion Criteria:
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Any current psychiatric/neurological comorbidity (e.g., epilepsy, Autism, depression, TBI, etc.), other than ADHD
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ADHD Medications (stimulants, non-stimulants, other)
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Undergoing Neurofeedback, cognitive training
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Max Stern Academic College of Emek Yezreel | Haifa | Israel |
Sponsors and Collaborators
- VIZO Specs Ltd
Investigators
- Principal Investigator: Zohar Elyoseph, PhD, Max Stern Academic College of Emek Yezreel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VIZO_004