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Behavioral Intervention
Vision Therapy for Post-Concussion Syndrome (PPCS-CI Trial)
N/A
Recruiting
Led By Tara L Alvarez, PhD
Research Sponsored by New Jersey Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between 13 to 25 years of age
Between 13 to 25 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 12 therapy session spanning 6 weeks
Awards & highlights
PPCS-CI Trial Summary
This trial will compare the differences between PPCS-CI and TYP-CI, discover the neural mechanism of OBVAT for PPCS-CI compared to standard-community concussion care, and determine the effectiveness of 12 one-hour sessions compared to 16 one-hour sessions of OBVAT.
Who is the study for?
This trial is for young people aged 13-25 who've had a concussion diagnosed by a professional 1 to 3 months ago and are experiencing eye coordination issues (convergence insufficiency) affecting reading or screen use. They must have certain levels of visual acuity and stereopsis, be willing to wear corrective lenses if needed, and meet specific criteria on an eye symptom survey.Check my eligibility
What is being tested?
The study tests office-based therapy aimed at improving the way eyes work together after a concussion. It compares neural mechanisms in typical convergence insufficiency with those post-concussion, assessing how effective either 12 or 16 one-hour therapy sessions are compared to standard care.See study design
What are the potential side effects?
Since this intervention involves non-invasive vision therapy exercises rather than medication, side effects may include temporary eyestrain or headaches as the eyes adjust to new patterns of coordination.
PPCS-CI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 13 and 25 years old.
Select...
I am between 13 and 25 years old.
PPCS-CI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 12 therapy session spanning 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 12 therapy session spanning 6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Near Point of Convergence with Positive Fusional Vergence
Secondary outcome measures
Functional Activity within vergence neural circuit
Vergence Peak Velocity
PPCS-CI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Office based Vergence and Accommodative Therapy immediately after enrollementExperimental Treatment1 Intervention
This arm will start immediately after baseline assessment. The participant will have two sessions of one hour each for 6 weeks (12 office-based vergence and accommodative therapy sessions). The first outcome measurement will be attained by a masked optometrist. Then, the participant will have 2 more weeks of therapy (4 office-based vergence and accommodative therapy sessions). The second and final outcome measurement will be attained. Assessments include a masked optometric vision exam, objective eye movement recordings and an functional MRI scan.
Group II: Office based Vergence and Accommodative Therapy Delay 6 weeks post enrollmentActive Control1 Intervention
This arm will start with a 6 week delay (no vision therapy) after baseline assessment to evaluate natural recovery. After 6 weeks, the first outcome assessment will be attained by a masked optometrist. The participant will have two sessions of one hour each for 8 weeks (16 office-based vergence and accommodative therapy sessions). The second and final outcome measurement will be attained. Assessments include a masked optometric vision exam, objective eye movement recordings and an functional MRI scan.
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Who is running the clinical trial?
Salus UniversityOTHER
14 Previous Clinical Trials
877 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,580,959 Total Patients Enrolled
National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,401,819 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a lazy eye or have had surgery for crossed eyes.I work with metals.An eye doctor has diagnosed you with convergence insufficiency, which means your eyes have trouble working together at close distances, and you have specific test results and symptoms.You have good depth perception, as measured by a specific eye test.I am willing to wear glasses or contacts if needed.You have been diagnosed with convergence insufficiency by an eye doctor based on specific tests and symptoms.I am between 13 and 25 years old.I do not have conditions like MS, thyroid issues, or diabetes affecting my eye movement.You have good depth perception as measured by a specific eye test.You have metal in your body that can't be taken out.I have done vision exercises like pencil push-ups at home or in an office.I was diagnosed with a concussion 1 to 3 months ago.You were diagnosed with a concussion by a doctor or nurse 1 to 3 months ago.You can see clearly with glasses or contacts both far away and up close.I am between 13 and 25 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Office based Vergence and Accommodative Therapy Delay 6 weeks post enrollment
- Group 2: Office based Vergence and Accommodative Therapy immediately after enrollement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have volunteered to partake in this research?
"Affirmative. The data available on clinicaltrials.gov attests that this trial, which was initially advertised in September 2021, is currently recruiting individuals to participate. They are seeking a total of 100 patients from three separate sites."
Answered by AI
What types of individuals are ideal candidates for this clinical exploration?
"In order to gain access to this trial, a patient must exhibit the symptoms of opsoclonus and be between 13-25 years old. Currently, the team is recruiting 100 participants."
Answered by AI
Does this clinical trial extend to adults aged 18 and above?
"This clinical trial requires participants to be between the ages of 13 and 25. There are 87 trials for those under 18 years old, as well as 243 trials for individuals aged 65 or above."
Answered by AI
Is the trial currently in need of volunteers?
"Affirmative. Clinicaltrials.gov reveals that the recruitment process for this study, which began on September 1st 2021, is still active. A total of 100 participants are needed from 3 separate clinical sites."
Answered by AI
Who else is applying?
What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
The Children's Hospital of Philadelphia
What portion of applicants met pre-screening criteria?
Met criteria
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