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

NCT05835336 | Completed Results

• 1 other identifier: VIZO_004
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ADHD

Keywords

ADHD; Peripheral Retinal Stimulation; Non-pharmacological treatment; Adolescents

Outcome Measures

Primary Outcomes (4)

• Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Total Score - at Baseline and 2 Months Follow up

  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

• Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Inattentiveness Subscale - at Baseline and 2 Months Follow up

  The Inattention subscale of the ADHD-RS contains 9 symptom items, that are designed to measure the child's attention level on tasks or play activities.The items are rated by the parent on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 27. Higher scores mean more symptoms and higher ADHD impairments.

  Baseline, 2-month

• Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Hyperactivity-Impulsivity Subscale - at Baseline and 2 Months Follow up

  The Hyperactivity-Impulsivity subscale of the ADHD-RS contains 9 symptom items, that are designed to measure the child's hyperactivity level and impulsivity level. The items are rated by the parent on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 27. Higher scores mean more symptoms and higher ADHD impairments.

  Baseline, 2-month

• Change in Behavior Rating Inventory of Executive Function (BRIEF) - Metacognitive Index - at Baseline and 2 Months Follow up

  The Metacognition Index (MI) of the BRIEF reflects a child's ability to self-manage and monitor tasks cognitively. The subscale is composed of the Initiate, Working Memory, Plan/Organize, Organization of Materials, and Monitor scales of the BRIEF. It uses a Likert-type response format ranging from 1 to 3, where 1 is never, 2 is sometimes, and 3 is often. The MI subscale includes 40-items with score ranges between 0 to 120. Higher values represent worse outcome and greater difficulties with executive functions. High scores indicate executive deficit.

  Baseline, 2-month

Secondary Outcomes (3)

• Clinical Global Impression-Improvement (CGI-I) - at 2 Months Follow up

  2-month

• Change in Behavior Rating Inventory of Executive Function (BRIEF) - Global Executive Composite - at Baseline and 2 Months Follow up

  Baseline, 2-month

• Change in Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up

  Baseline, 2 months

Study Arms (1)

Active

EXPERIMENTAL

VIZO Glasses- personalized

Device: VIZO Glasses

Interventions

VIZO Glasses DEVICE

Eyeglasses with personalized peripheral retinal stimuli

Active

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Documented history of primary ADHD diagnosis by certified clinicians
• Age 12-17 y
• Minimum total of 24 on the parent ADHD-IV Rating Scale (ADHD-RS)
• Written informed consent
• Able and willing to complete all required ratings and assessments

You may not qualify if:

• 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

Sponsors & Collaborators

• VIZO Specs Ltd: lead

Study Sites (1)

Max Stern Academic College of Emek Yezreel

Haifa, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Yael Richter, PhD
• Organization: VIZO Specs

yaelr@vizo-o.com

972-54-7384809

Study Officials

• Zohar Elyoseph, PhD

  Max Stern Academic College of Emek Yezreel

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: April 1, 2022
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: March 24, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-03

Locations

IL (1)