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

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 Adolescents.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05835336
• Other study ID #: VIZO_004
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: September 2023

Study information

• Verified date: March 2023
• Source: VIZO Specs Ltd
• Contact: Yael Richter, PhD
• Phone: +972-54-7384809
• Email: yaelr[@]vizo-o.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

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 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	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
Secondary	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
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-month