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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

Must not have

Amblyopia (lazy eye) or constant strabismus or strabismus surgery

Metal worker

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 12 therapy session spanning 6 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 13 and 25 years old.

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I am between 13 and 25 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a lazy eye or have had surgery for crossed eyes.

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I work with metals.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 12 therapy session spanning 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Near Point of Convergence with Positive Fusional Vergence

Secondary study objectives

Functional Activity within vergence neural circuit

Vergence Peak Velocity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met