A Novel Device for the Management of ADHD

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05777785
• Other study ID #: VIZO_003
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: March 26, 2023

Study information

• Verified date: August 2023
• Source: VIZO Specs Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 26, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Device:
• VIZO Glasses
Eyeglasses with personalized peripheral retinal stimuli

Locations

Country	Name	City	State
Israel	Max Stern Academic College of Emek Yezreel	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
VIZO Specs Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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