A Novel, Non-pharmacological, Intervention for the Management of ADHD in Adolescents
Primary Purpose
ADHD
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
VIZO Glasses
Sponsored by
About this trial
This is an interventional treatment trial for ADHD focused on measuring ADHD, Peripheral Retinal Stimulation, Non-pharmacological treatment, Adolescents
Eligibility Criteria
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
Sites / Locations
- Max Stern Academic College of Emek YezreelRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active
Arm Description
VIZO Glasses- personalized
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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').
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05835336
Brief Title
A Novel, Non-pharmacological, Intervention for the Management of ADHD in Adolescents
Official Title
A Pilot Study to Assess the Efficacy and Safety of a Novel Device (VIZO Glasses) in the Management of ADHD in Adolescents.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VIZO Specs Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a 2-month study in which eligible ADHD adolescents will be provided with personalized VIZO Glasses
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, Peripheral Retinal Stimulation, Non-pharmacological treatment, Adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
VIZO Glasses- personalized
Intervention Type
Device
Intervention Name(s)
VIZO Glasses
Intervention Description
Eyeglasses with personalized peripheral retinal stimuli
Primary Outcome Measure Information:
Title
Change in the ADHD Rating Scale (ADHD-RS) parent-report questionnaire
Description
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.
Time Frame
Baseline, 2-month
Secondary Outcome Measure Information:
Title
Change in Behavior Rating Inventory of Executive Function (BRIEF)
Description
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').
Time Frame
Baseline, 2-month
Title
Change in Conners' Continuous Performance Test-3 (CPT-3)
Description
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.
Time Frame
Baseline, 2-month
Title
Clinical Global Impression-Improvement (CGI-I)
Description
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-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yael Richter, PhD
Phone
+972-54-7384809
Email
yaelr@vizo-o.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zohar Elyoseph, PhD
Organizational Affiliation
Max Stern Academic College of Emek Yezreel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Max Stern Academic College of Emek Yezreel
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zohar Elyoseph, PhD
Email
zohar.j.a@gmail.com
12. IPD Sharing Statement
Learn more about this trial
A Novel, Non-pharmacological, Intervention for the Management of ADHD in Adolescents
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