Vision Therapy for Post-Concussion Syndrome

(PPCS-CI Trial)

Recruiting at 2 trial locations

Overseen By Tara L Alvarez, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: New Jersey Institute of Technology

Disqualifiers: Amblyopia, Strabismus, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 19

Duration: 6-14 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Our successful R01 discovered 1) the neural mechanistic difference between typically occurring convergence insufficiency (TYP-CI) and binocularly normal controls and 2) the underlying mechanism of office-based vergence and accommodative therapy (OBVAT) that is effective in remediating symptoms. Adolescent and young adult concussion is considered a substantial health problem in the United States where our team has shown that about half of patients with persistent post-concussion symptoms have convergence insufficiency (PPCS-CI), causing significant negative impact associated with reading or digital screen-related activities, and is believed to be one factor causing delayed recovery impacting return to school, sports, or work. The results of this randomized clinical trial will impact the lives of adolescents and young adults with PPCS-CI to guide professionals on how to manage and treat those with PPCS-CI by 1) comparing the differences between PPCS-CI and TYP-CI, 2) discovering the neural mechanism of OBVAT for PPCS-CI compared to standard-community concussion care, and 3) determining the effectiveness of 12 one-hour sessions compared to 16 one-hour sessions of OBVAT.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have conditions like Multiple Sclerosis, Graves' thyroid disease, Myasthenia Gravis, Diabetes, or Parkinson's Disease, you may not be eligible to participate.

What data supports the effectiveness of the treatment Office-based Vergence and Accommodative Therapy for Post-Concussion Syndrome?

Research shows that Office-Based Vergence/Accommodative Therapy (OBVAT) is effective for treating convergence insufficiency (difficulty focusing both eyes together) in about 75% of patients. Additionally, vision therapy has been shown to improve abnormal eye movement responses in people with mild traumatic brain injury, indicating potential benefits for post-concussion syndrome. ^{1 2 3 4 5}

Is vision therapy safe for humans?

Vision therapy, including office-based vergence and accommodative therapy, is generally considered safe for humans. It is a noninvasive treatment used for various vision disorders, and studies have shown it can help improve symptoms without significant safety concerns. ^{2 3 4 5 6}

How is the treatment Office-based Vergence and Accommodative Therapy (OBVAT) different from other treatments for post-concussion syndrome?

Office-based Vergence and Accommodative Therapy (OBVAT) is unique because it specifically targets vision problems like convergence insufficiency and accommodative disorders, which are common after a concussion. This therapy uses exercises to improve eye coordination and focus, leveraging the brain's ability to adapt and recover, unlike other treatments that may not directly address these specific vision issues. ^{2 3 5 7 8}

Research Team

Tara Alvarez, PhD

Principal Investigator

New Jersey Institute of Technology

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

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

Pregnant, planning on becoming pregnant during the study duration, or breastfeeding

I work with metals.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment including a masked optometric vision exam, objective eye movement recordings, and a functional MRI scan

1 week

1 visit (in-person)

Treatment

Participants receive office-based vergence and accommodative therapy. One arm starts immediately with 12 sessions over 6 weeks, followed by 4 additional sessions over 2 weeks. Another arm starts after a 6-week delay with 16 sessions over 8 weeks.

6-14 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including outcome assessments by a masked optometrist

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Office-based Vergence and Accommodative Therapy

Trial Overview 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.

Participant Groups

Group I: Office based Vergence and Accommodative Therapy immediately after enrollement Experimental Treatment 1 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 enrollment Active Control 1 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.

Office-based Vergence and Accommodative Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Office-based Vergence/Accommodative Therapy for:

• Convergence Insufficiency
• Persistent Post-Concussion Symptoms

Approved in European Union as Office-based Vergence/Accommodative Therapy for:

• Convergence Insufficiency

Who Is Running the Clinical Trial?

New Jersey Institute of Technology

Lead Sponsor

Trials

11

Recruited

1,100+

Salus University

Collaborator

Trials

16

Recruited

1,100+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

Somerset Pediatric Group

Collaborator

Trials

1

Recruited

100+

Findings from Research

In a study of 40 patients (33 with mild traumatic brain injury and 7 with cerebrovascular accident) who underwent optometric vision therapy, 90% of TBI patients and 100% of CVA patients showed significant improvement in oculomotor dysfunctions, indicating high efficacy of the therapy.

The improvements in symptoms and clinical signs were stable at a follow-up 2 to 3 months later, suggesting that optometric vision therapy can lead to lasting benefits and highlights the brain's ability to adapt and recover despite injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision therapy for oculomotor dysfunctions in acquired brain injury: a retrospective analysis. Ciuffreda, KJ., Rutner, D., Kapoor, N., et al.[2022]

This study evaluated the effects of office-based vision therapy (OBVT) on five individuals with concussion-related convergence insufficiency (CI) and found significant improvements in objective measures of disparity vergence, including peak velocity and accuracy, indicating that OBVT can effectively enhance eye coordination after a concussion.

The research suggests that objective measures of disparity vergence can provide valuable insights into the physiological changes associated with CI, making them suitable for use in larger clinical trials to assess treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective Assessment of Vergence after Treatment of Concussion-Related CI: A Pilot Study. Scheiman, MM., Talasan, H., Mitchell, GL., et al.[2018]

Individuals with mild traumatic brain injury (mTBI) show abnormal vergence and accommodation responses, including slowed and inaccurate dynamics compared to healthy controls, indicating significant visual processing issues.

Short-term oculomotor-based vision therapy can partially remediate these abnormalities, suggesting that the brain retains a degree of neuroplasticity even after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objectively-based vergence and accommodative dynamics in mild traumatic brain injury (mTBI): A mini review. Ciuffreda, KJ., Thiagarajan, P.[2022]

Office-Based Vergence/Accommodative Therapy (OBVAT) effectively treats convergence insufficiency (CI), improving symptoms in about 75% of patients, as shown in a study with 25 symptomatic CI patients who underwent 12 hours of therapy.

Post-therapy assessments revealed significant improvements in near point of convergence, positive fusional vergence, and reduced symptoms, alongside increased functional brain activity in areas related to eye movement control, indicating that OBVAT not only enhances visual function but also engages neural mechanisms involved in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Functional Imaging Changes Induced from Vision Therapy in Patients with Convergence Insufficiency. Alvarez, TL., Scheiman, M., Santos, EM., et al.[2020]

Vision disturbances after traumatic brain injury (TBI) can be effectively addressed through noninvasive rehabilitative interventions like vision therapy, which is provided by optometrists.

Rehabilitative optometric interventions, including the use of specialized spectacles and vision therapy, are beneficial for many TBI patients and should be considered as treatment options to improve their visual function and overall recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision Disturbances Following Traumatic Brain Injury. Kapoor, N., Ciuffreda, KJ.[2020]

In a study of 19 adults with binocular vision disorders following brain injury, 12 weeks of home-based computer vergence therapy led to significant improvements in various measures of eye function, including near point of convergence and vergence facility.

Approximately 69% of participants showed successful improvement in near point of convergence, and 92% improved in vergence facility, indicating that this therapy can effectively enhance binocular vision and reduce symptoms associated with convergence insufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision Therapy for Binocular Dysfunction Post Brain Injury. Conrad, JS., Mitchell, GL., Kulp, MT.[2018]

In a study of 113 adolescents aged 11 to 17, 70% were found to have at least one vision-related diagnosis after a concussion, with the most common issues being vergence disorders (60%) and accommodative disorders (57%).

Current physician-administered screening methods for detecting these vision problems are not very effective, with sensitivities as low as 63% for convergence insufficiency, indicating that comprehensive oculomotor evaluations are necessary for adolescents with persistent post-concussion symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency of oculomotor disorders in adolescents 11 to 17 years of age with concussion, 4 to 12 weeks post injury. Scheiman, M., Grady, MF., Jenewein, E., et al.[2022]

Optometric visual rehabilitation therapy is commonly used for various visual disorders, particularly in patients with conditions like posttrauma visual syndrome and visual midline shift syndrome, often following strokes or head injuries.

However, the scientific evidence supporting these therapies is limited, primarily consisting of case reports and series without control groups, indicating a need for more rigorous studies to validate their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consensus Statement on Visual Rehabilitation in Mild Traumatic Brain Injury. Subramanian, PS., Barton, JJS., Ranalli, P., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Vision therapy for oculomotor dysfunctions in acquired brain injury: a retrospective analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Objective Assessment of Vergence after Treatment of Concussion-Related CI: A Pilot Study. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Objectively-based vergence and accommodative dynamics in mild traumatic brain injury (mTBI): A mini review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical and Functional Imaging Changes Induced from Vision Therapy in Patients with Convergence Insufficiency. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Vision Disturbances Following Traumatic Brain Injury. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Vision Therapy for Binocular Dysfunction Post Brain Injury. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Frequency of oculomotor disorders in adolescents 11 to 17 years of age with concussion, 4 to 12 weeks post injury. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Consensus Statement on Visual Rehabilitation in Mild Traumatic Brain Injury. [2022]