ADHD
Conditions
Keywords
ADHD, Peripheral Retinal Stimulation, non-pharmacological
Brief summary
This is a 2-months study, where eligible ADHD adult participants will be provided with personalized VIZO glasses.
Detailed 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) .
Interventions
Eyeglasses with personalized peripheral retinal stimuli
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adult ADHD Self-Report Scale (ASRS) - Total Score at Baseline and 2 Months Follow up | Baseline, 2 months | The Adult ADHD Self-Report Scale (ASRS) is a self-report instrument that comprises eighteen items that correspond with the DSM-V-TR criteria for ADHD. Subjects are asked to rate 18 symptom items using a 5-point Likert scale ranging from 0 ('Never') to 4 ('Very Often'). Total scores range from 0 to 72, based on the sum of all 18 questions. Higher scores mean more symptoms and higher ADHD's impairments. Lower values represent better outcomes. The ASRS has two subscales that can be used to identify ADHD subtypes - Inattentiveness and Hyperactivity/Impulsivity. Each subscale contains 9 questions. |
| Adult ADHD Self-Report Scale (ASRS) - Inattentiveness Subscale Score at Baseline and 2 Months Follow up | Baseline, 2 months | The inattentiveness sub-scale of the ASRS measures difficulties with focusing on details, organisation, remembering appointments, making careless mistakes, and concentration. It includes 9 symptom items using a 5-point Likert scale ranging from 0 ('Never') to 4 ('Very Often'). Total scores range from 0 to 36, based on the sum of all questions. Higher scores mean more symptoms and higher inattentiveness' impairments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression-Improvement (CGI-I) - Rate at 2 Months Follow up | 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. |
| Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up | 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. CPT scores are age and gender standardized T-scores, in which the mean is equal to 50 and the standard deviation is equal to 10. d' is reverse-scored so that higher raw score and T-score values indicate worse performance (i.e., poorer discrimination). Atypical scores are higher than 60 indicating elevated to very elevated performance. |
| Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) - Metacognitive Index - at Baseline and 2 Months Follow up | Baseline, 2 months | The Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) is a standardized measure that captures views of adults' executive functions or self-regulation in their everyday environment. Items are rated on a 3-points Likert scale of 1 ('Never') to 3 ('Often'). The Metacognition Index (MI) of the BRIEF-A reflects the individual's ability to initiate activity and generate problem-solving ideas, to sustain working memory, to plan and organize problem-solving approaches, to monitor success and failure in problem solving, and to organize one's materials and environment. The MI subscale includes 40-items with score ranges between 40 to 120. Higher values represent worse outcome and greater difficulties with executive functions. |
Countries
Israel
Participant flow
Pre-assignment details
108 partcipants met the inclusion criteria. Two participants failed to comply with the personalization process due to difficulty staying awake or using a cell phone during the test, resulting in 106 participants receiving the intervention.
Participants by arm
| Arm | Count |
|---|---|
| Active VIZO Glasses- personalized
VIZO Glasses: Eyeglasses with personalized peripheral retinal stimuli. Participants were instructed to wear the glasses throughout the day for two months. | 97 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Active | — |
|---|---|---|
| Adult ADHD Self-Report Scale (ASRS) - Hyperactivity/Impulsivity subscale | 18.56 units on a scale STANDARD_DEVIATION 6.64 | — |
| Adult ADHD Self-Report Scale (ASRS) - Inattentiveness Subscale | 21.2 units on a scale STANDARD_DEVIATION 6.68 | — |
| Adult ADHD Self-Report Scale (ASRS) - Total Score | 39.76 units on a scale STANDARD_DEVIATION 12.1 | — |
| Age, Continuous | 26.51 years STANDARD_DEVIATION 4.59 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 51 Participants | — |
| Sex: Female, Male Male | 46 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 64 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Adult ADHD Self-Report Scale (ASRS) - Inattentiveness Subscale Score at Baseline and 2 Months Follow up
The inattentiveness sub-scale of the ASRS measures difficulties with focusing on details, organisation, remembering appointments, making careless mistakes, and concentration. It includes 9 symptom items using a 5-point Likert scale ranging from 0 ('Never') to 4 ('Very Often'). Total scores range from 0 to 36, based on the sum of all questions. Higher scores mean more symptoms and higher inattentiveness' impairments.
Time frame: Baseline, 2 months
Population: Two participants did not complete the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Adult ADHD Self-Report Scale (ASRS) - Inattentiveness Subscale Score at Baseline and 2 Months Follow up | Baseline | 21.20 score on a scale | Standard Error 0.69 |
| Active | Adult ADHD Self-Report Scale (ASRS) - Inattentiveness Subscale Score at Baseline and 2 Months Follow up | End of study | 20.22 score on a scale | Standard Error 0.72 |
Adult ADHD Self-Report Scale (ASRS) - Total Score at Baseline and 2 Months Follow up
The Adult ADHD Self-Report Scale (ASRS) is a self-report instrument that comprises eighteen items that correspond with the DSM-V-TR criteria for ADHD. Subjects are asked to rate 18 symptom items using a 5-point Likert scale ranging from 0 ('Never') to 4 ('Very Often'). Total scores range from 0 to 72, based on the sum of all 18 questions. Higher scores mean more symptoms and higher ADHD's impairments. Lower values represent better outcomes. The ASRS has two subscales that can be used to identify ADHD subtypes - Inattentiveness and Hyperactivity/Impulsivity. Each subscale contains 9 questions.
Time frame: Baseline, 2 months
Population: Two participants did not complete the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Adult ADHD Self-Report Scale (ASRS) - Total Score at Baseline and 2 Months Follow up | Baseline | 39.76 score on a scale | Standard Error 1.24 |
| Active | Adult ADHD Self-Report Scale (ASRS) - Total Score at Baseline and 2 Months Follow up | End of study | 38.27 score on a scale | Standard Error 1.31 |
Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) - Metacognitive Index - at Baseline and 2 Months Follow up
The Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) is a standardized measure that captures views of adults' executive functions or self-regulation in their everyday environment. Items are rated on a 3-points Likert scale of 1 ('Never') to 3 ('Often'). The Metacognition Index (MI) of the BRIEF-A reflects the individual's ability to initiate activity and generate problem-solving ideas, to sustain working memory, to plan and organize problem-solving approaches, to monitor success and failure in problem solving, and to organize one's materials and environment. The MI subscale includes 40-items with score ranges between 40 to 120. Higher values represent worse outcome and greater difficulties with executive functions.
Time frame: Baseline, 2 months
Population: Four participants did not complete the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) - Metacognitive Index - at Baseline and 2 Months Follow up | Baseline | 79.85 score on a scale (raw scores) | Standard Error 1.75 |
| Active | Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) - Metacognitive Index - at Baseline and 2 Months Follow up | End of Study | 77.76 score on a scale (raw scores) | Standard Error 1.75 |
Clinical Global Impression-Improvement (CGI-I) - Rate at 2 Months Follow up
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.
Time frame: 2 months
Population: Nine participants did not participate in the clinicial interview.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active | Clinical Global Impression-Improvement (CGI-I) - Rate at 2 Months Follow up | CGI-I score of 1, 2 or 3 | 77 Participants |
| Active | Clinical Global Impression-Improvement (CGI-I) - Rate at 2 Months Follow up | CGI-I score of 4 or higher | 11 Participants |
Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up
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. CPT scores are age and gender standardized T-scores, in which the mean is equal to 50 and the standard deviation is equal to 10. d' is reverse-scored so that higher raw score and T-score values indicate worse performance (i.e., poorer discrimination). Atypical scores are higher than 60 indicating elevated to very elevated performance.
Time frame: Baseline, 2 months
Population: Four participants did not complete the CPT.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up | Baseline | 50.03 T-score | Standard Error 0.9 |
| Active | Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up | End of Study | 47.95 T-score | Standard Error 1.06 |