Clinical trial NCT05835336: 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
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: ADHD
Peripheral Retinal Stimulation
Non-pharmacological treatment
Adolescents
Lead sponsor: VIZO Specs Ltd
Sponsor class: INDUSTRY
First posted: 2023-04-28
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Total Score - at Baseline and 2 Months Follow up
timeFrame: Baseline, 2-month
measure: Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Inattentiveness Subscale - at Baseline and 2 Months Follow up
timeFrame: Baseline, 2-month
measure: Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Hyperactivity-Impulsivity Subscale - at Baseline and 2 Months Follow up
timeFrame: Baseline, 2-month
measure: Change in Behavior Rating Inventory of Executive Function (BRIEF) - Metacognitive Index - at Baseline and 2 Months Follow up
timeFrame: Baseline, 2-month
Secondary outcomes:
measure: Clinical Global Impression-Improvement (CGI-I) - at 2 Months Follow up
timeFrame: 2-month
measure: Change in Behavior Rating Inventory of Executive Function (BRIEF) - Global Executive Composite - at Baseline and 2 Months Follow up
timeFrame: Baseline, 2-month
measure: Change in Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up
timeFrame: Baseline, 2 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Max Stern Academic College of Emek Yezreel
Study officials:
affiliation: Max Stern Academic College of Emek Yezreel
name: Zohar Elyoseph, PhD
role: PRINCIPAL_INVESTIGATOR
References: