A Novel Device for the Management of ADHD
Study Details
Study Description
Brief Summary
This is a 2-months study, where eligible ADHD adult participants will be provided with personalized VIZO glasses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study was designed as a pilot single-center, open-label study of 2 months treatment. Following the enrollment & baseline visit participants will be provided with personalized VIZO glasses. Assessment of the immediate effect of VIZO glasses on attentional performance will be assessed by conducting standardized tests of a attention twice. The first assessment will be conducted wearing standard eyeglasses (with no peripheral retinal stimulation), after 10 minutes the assessment will be conducted again, wearing VIZO Glasses. The participants will be then instructed to wear VIZO glasses throughout the day for a period of 2 months. At the end of the treatment period a follow up visit will be conducted assessing 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) .
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active VIZO Glasses- personalized |
Device: VIZO Glasses
Eyeglasses with personalized peripheral retinal stimuli
|
Outcome Measures
Primary Outcome Measures
- Change in Adult ADHD Self-Report Scale (ASRS) [Baseline, 2 months]
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) [2 months]
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') [Baseline, 2 months]
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) [Baseline, 2 months]
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').
- Change in Trial Making Test (TMT) [Baseline, within 10 minutes of wearing VIZO Glasses]
The TMT encompasses visual attention and processing speed, it consists of 2 parts in which a set of 25 dots in the first part and 24 dots in the second part have to be accurately connected. Time performance is measured as the main outcome.
- Change in Stroop Test [Baseline, within 10 minutes of wearing VIZO Glasses]
This is a frequently used test measuring primarily selective attention, by inhibiting an automatic response. Reaction time is the primary measure.
- Change in Modified Posner's paradigms using eye tracking [Baseline, within 10 minutes of wearing VIZO Glasses]
Posner's paradigm is a neuropsychological test often used to assess attention by assessing a person's ability to perform an attentional shift. Oculomotor reaction time will be measured.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Documented history of primary ADHD diagnosis by certified clinicians
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Age 18-40 y
-
Written informed consent
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Able and willing to complete all required ratings and assessments
Exclusion criteria:
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Any current psychiatric / neurological comorbidity (e.g., epilepsy, Autism, depression, TBI, etc), other than ADHD
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ADHD Medications (stimulants, non-stimulants, other)
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Neurofeedback, cognitive training
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Max Stern Academic College of Emek Yezreel | Haifa | Israel |
Sponsors and Collaborators
- VIZO Specs Ltd
Investigators
- Principal Investigator: Zohar Elyoseph, PhD, Max Stern Academic College of Emek Yezreel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VIZO_003