A Novel Device for the Management of ADHD
Primary Purpose
ADHD
Status
Completed
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
Eligibility Criteria
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
Sites / Locations
- Max Stern Academic College of Emek Yezreel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active
Arm Description
VIZO Glasses- personalized
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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').
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05777785
Brief Title
A Novel Device for the Management of ADHD
Official Title
A Pilot Study to Assess the Efficacy and Safety of a Novel Device (VIZO Glasses) in the Management of ADHD in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 26, 2023 (Actual)
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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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) .
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)
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 Adult ADHD Self-Report Scale (ASRS)
Description
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.
Time Frame
Baseline, 2 months
Secondary Outcome Measure Information:
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 months
Title
Change in Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d')
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.
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).
Time Frame
Baseline, 2 months
Title
Change in Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A)
Description
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').
Time Frame
Baseline, 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
12. IPD Sharing Statement
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A Novel Device for the Management of ADHD
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