Persistent Post-concussive SymptomsPPCS-CINCT05262361
Persistent Post-Concussion Symptoms With Convergence Insufficiency
A study testing Office-based Vergence and Accommodative Therapy in people with Persistent Post-concussive Symptoms and Convergence Insufficiency, run by New Jersey Institute of Technology at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 35 years
- Conditions the study is for
- Persistent Post-concussive Symptoms, Convergence Insufficiency, Mild Traumatic Brain Injury
- What is being tested?
- Office-based Vergence and Accommodative Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2021to 19 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between 11 to 35 years
- Concussion diagnosed by a clinical 1 to 6 months ago
- Best-corrected visual acuity of 20/25 in both eyes at distance and near
- willing to wear glasses or contact to correct refractive error if needed
- Global stereopsis of 500 sec of arc or better and 70 sec of arc of better using Randot Stereo Test
- Diagnosis of convergence insufficiency from an optometrist defined as near point of convergence of greater than or equal to 6 cm, positive fusional vergence at 40 cm not meeting Sheard's criteria of at least twice the near phoria or a range of less than or equal to 15 prism diopters, and a convergence insufficiency symptom survey score of 21 or greater for adults or 16 or greater for children.
Who cannot join
- History of performing office or home-based vision therapy, orthoptics, home-based near target push-ups, or pencil push ups
- Amblyopia (lazy eye) or constant strabismus or strabismus surgery
- Any conditions or diseases that affect accommodation, vergence or ocular motility, such as Multiple Sclerosis, Graves' thyroid disease, Myastheria Gravis, Diabetes, Chemotherapy, or Parkinson's Disease
- Non-removable metal in the body
- Pregnant, planning on becoming pregnant during the study duration, or breastfeeding
- Metal worker
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NJIT
Newark, New Jersey, 07102
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Functional Mechanism of Neural Control in Persistent Post-Concussion Symptoms Convergence Insufficiency
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.
Read the detailed description
During the past 6 years, our study team investigated the neural mechanism of typically-occurring convergence insufficiency (TYP-CI), the most common binocular vision disorder in children and young adults (3.4% to 12.7%5-11). We conducted the only randomized clinical trial (RCT) integrating objective eye movement and fMRI outcome measures, achieving 100% planned enrollment and retention of 100 young adults. Our results localized the reduction in functional activity for TYP-CI compared to controls within the oculomotor vermis (OVM) and the cuneus. Functional activity in the OVM and cuneus was significantly correlated to convergence peak velocity providing the first mechanistic identification of these deficits that create significant burden to those afflicted. Our longitudinal results discovered that the neural mechanistic change stimulated by office-based vergence /accommodative therapy (OBVAT) is an increase in the frontal eye field (FEF) and thalamus functional activity. Increased functional activity from the FEF and thalamus significantly correlates to convergence peak velocity. Results are leading to personalized point-of-care therapies remediating the debilitating symptoms for TYP-CI patients. While our research and results of other RCTs show that OBVAT is the most effective treatment for remediating symptoms and improving vision function in both TYP-CI children and adults, none of these participants had a history of head injury, a pathology that has been linked to CI. Our research team has demonstrated that the prevalence of CI is higher (38% to 49%) in children and adults with persistent post-concussive symptoms (PPCS-CI), than in the non-concussed population. Currently, there is no validated treatment for PPCS-CI. This difference in prevalence, mode of onset (longstanding versus sudden onset), and severity of the condition has led to a debate about whether the diagnostic and management procedures effective for TYP-CI should be utilized for PPCS-CI, and strongly suggests that new research is needed to optimize PPCS-CI management. We are uniquely positioned to provide answers to these questions by building on our work establishing the neurofunctional mechanism of TYP-CI and OBVAT administered to TYP-CI. Such research is of great importance because PPCS-CI is associated with debilitating visual symptoms impacting the return to school/sports, work, or driving. We have identified three significant gaps for the treatment of PPCS-CI that must be addressed to determine its most effective management. First, given the obvious differences in etiology, are there significant differences between TYP-CI and PPCS-CI related to objective eye movement measures (peak velocity, final amplitude, and repeatability) due to underlying neural mechanistic differences? Second, what is the underlying neural mechanism of OBVAT for PPCS-CI compared to TYP-CI? Third, how effective is OBVAT for PPCS-CI and is the dosage of administration different than TYP-CI? This renewal addresses these gaps in clinical science.
- Conditions
- Persistent Post-concussive Symptoms, Convergence Insufficiency, Mild Traumatic Brain Injury, Concussion, Mild, Concussion; Eye
- Being tested
- Office-based Vergence and Accommodative Therapy
- Medical subject headings
- Ocular Motility Disorders, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office-based Vergence and Accommodative TherapyBehavioural
Office-based Vergence and Accommodative Therapy has four phases which start with gross vergence and accommodation. Disparity vergence is isolated using instruments such as vectograms and accommodation is isolated using near far charts and accommodative rock. The final phase includes the integration of vergence and accommodation to increase range and visual comfort which performing activities close to the person.
| Study group | Role | What they receive |
|---|---|---|
| Office based Vergence and Accommodative Therapy immediately after enrollement | Experimental | 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. Receives: Behavioral: Office-based Vergence and Accommodative Therapy |
| Office based Vergence and Accommodative Therapy Delay 6 weeks post enrollment | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near Point of Convergence with Positive Fusional Vergence
Composite score of how close a participant can view a target a single along midline combined with positive fusional vergence range.
Measured: after 12 therapy session spanning 6 weeks
Secondary outcomes (2)
Vergence Peak Velocity
The maximum speed of a person looking from far to near along midline
Measured: after 12 therapy session spanning 6 weeks
Functional Activity within vergence neural circuit
The amount of blood oxygenation level dependent signal from vergence neural circuit
Measured: after 12 therapy session spanning 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Sep 2021
- Primary completion19 Jan 2026
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Persistent Post-concussive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The are two arms. Arm 1 will have participants will have office-based vergence and accommodative therapy (twice per week) immediately after enrollment while arm 2 will have participants have a 6 week delay before enrollment of therapy. There are three assessments: baseline, outcome 1 which is at 6 weeks (arm 1 would be after 12 sessions of therapy and arm 2 would not have participants in vision therapy yet), and outcome 2 which after vision therapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Jersey Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Salus University, Children's Hospital of Philadelphia, National Eye Institute (NEI), Rutgers University
- Responsible party
- Principal investigator, Dr. Tara Lynn Alvarez, New Jersey Institute of Technology
- Investigators
- Tara L Alvarez, PhD, Principal investigator, New Jersey Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262361
- Sponsor's protocol ID
- 2R01EY023261
- Other IDs
- 2R01EY023261
- Acronym
- PPCS-CI
- Status last verified
- Jan 2026
- First submitted
- 21 Feb 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: imaging data will be uploaded to FITBIR at the end of the study. Eye movement and clinical data (without any personal identifiers) will be available upon request to the principal investigator (Tara Alvarez, PhD) at the end of the study
Publications
Alvarez TL, Scheiman M, Hajebrahimi F, Noble M, Gohel S, Baro R, Bachman JA, Master CL, Goodman A; CONCUSS Investigator Group. CONCUSS randomised clinical trial of vergence/accommodative therapy for concussion-related symptomatic convergence insufficiency. Br J Sports Med. 2026 Mar 12;60(5):340-354. doi: 10.1136/bjsports-2025-109807.
PubMed 41033748Alvarez TL, Scheiman M, Gohel S, Hajebrahimi F, Noble M, Sangoi A, Yaramothu C, Master CL, Goodman A. Effectiveness of treatment for concussion-related convergence insufficiency: The CONCUSS study protocol for a randomized clinical trial. PLoS One. 2024 Nov 15;19(11):e0314027. doi: 10.1371/journal.pone.0314027. eCollection 2024.
PubMed 39546477
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Mechanism of Neural Control in Persistent Post-Concussion Symptoms Convergence Insufficiency
- ClinicalTrials.gov ID
- NCT05262361
- Acronym / sponsor ID
- PPCS-CI / 2R01EY023261
- Conditions
- Persistent Post-concussive Symptoms, Convergence Insufficiency, Mild Traumatic Brain Injury, Concussion, Mild, Concussion; Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- New Jersey Institute of TechnologyUniversity, hospital or other
- Collaborators
- Salus University, Children's Hospital of Philadelphia, National Eye Institute (NEI), Rutgers University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 19 Jan 2026 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During the past 6 years, our study team investigated the neural mechanism of typically-occurring convergence insufficiency (TYP-CI), the most common binocular vision disorder in children and young adults (3.4% to 12.7%5-11). We conducted the only randomized clinical trial (RCT) integrating objective eye movement and fMRI outcome measures, achieving 100% planned enrollment and retention of 100 young adults. Our results localized the reduction in functional activity for TYP-CI compared to controls within the oculomotor vermis (OVM) and the cuneus. Functional activity in the OVM and cuneus was significantly correlated to convergence peak velocity providing the first mechanistic identification of these deficits that create significant burden to those afflicted. Our longitudinal results discovered that the neural mechanistic change stimulated by office-based vergence /accommodative therapy (OBVAT) is an increase in the frontal eye field (FEF) and thalamus functional activity. Increased functional activity from the FEF and thalamus significantly correlates to convergence peak velocity. Results are leading to personalized point-of-care therapies remediating the debilitating symptoms for TYP-CI patients. While our research and results of other RCTs show that OBVAT is the most effective treatment for remediating symptoms and improving vision function in both TYP-CI children and adults, none of these participants had a history of head injury, a pathology that has been linked to CI. Our research team has demonstrated that the prevalence of CI is higher (38% to 49%) in children and adults with persistent post-concussive symptoms (PPCS-CI), than in the non-concussed population. Currently, there is no validated treatment for PPCS-CI. This difference in prevalence, mode of onset (longstanding versus sudden onset), and severity of the condition has led to a debate about whether the diagnostic and management procedures effective for TYP-CI should be utilized for PPCS-CI, and strongly suggests that new research is needed to optimize PPCS-CI management. We are uniquely positioned to provide answers to these questions by building on our work establishing the neurofunctional mechanism of TYP-CI and OBVAT administered to TYP-CI. Such research is of great importance because PPCS-CI is associated with debilitating visual symptoms impacting the return to school/sports, work, or driving. We have identified three significant gaps for the treatment of PPCS-CI that must be addressed to determine its most effective management. First, given the obvious differences in etiology, are there significant differences between TYP-CI and PPCS-CI related to objective eye movement measures (peak velocity, final amplitude, and repeatability) due to underlying neural mechanistic differences? Second, what is the underlying neural mechanism of OBVAT for PPCS-CI compared to TYP-CI? Third, how effective is OBVAT for PPCS-CI and is the dosage of administration different than TYP-CI? This renewal addresses these gaps in clinical science.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The are two arms. Arm 1 will have participants will have office-based vergence and accommodative therapy (twice per week) immediately after enrollment while arm 2 will have participants have a 6 week delay before enrollment of therapy. There are three assessments: baseline, outcome 1 which is at 6 weeks (arm 1 would be after 12 sessions of therapy and arm 2 would not have participants in vision therapy yet), and outcome 2 which after vision therapy.
| Arm | Type | Receives |
|---|---|---|
| Office based Vergence and Accommodative Therapy immediately after enrollement | Experimental | Behavioral: Office-based Vergence and Accommodative TherapyThis 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. |
| Office based Vergence and Accommodative Therapy Delay 6 weeks post enrollment | No 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. |
Who may qualify
- Ages
- 11 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Between 11 to 35 years
- Concussion diagnosed by a clinical 1 to 6 months ago
- Best-corrected visual acuity of 20/25 in both eyes at distance and near
- willing to wear glasses or contact to correct refractive error if needed
- Global stereopsis of 500 sec of arc or better and 70 sec of arc of better using Randot Stereo Test
Key exclusion criteria (6 listed)
- History of performing office or home-based vision therapy, orthoptics, home-based near target push-ups, or pencil push ups
- Amblyopia (lazy eye) or constant strabismus or strabismus surgery
- Any conditions or diseases that affect accommodation, vergence or ocular motility, such as Multiple Sclerosis, Graves' thyroid disease, Myastheria Gravis, Diabetes, Chemotherapy, or Parkinson's Disease
- Non-removable metal in the body
- Pregnant, planning on becoming pregnant during the study duration, or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Office-based Vergence and Accommodative TherapyOffice-based Vergence and Accommodative Therapy has four phases which start with gross vergence and accommodation. Disparity vergence is isolated using instruments such as vectograms and accommodation is isolated using near far charts and accommodative rock. The final phase includes the integration of vergence and accommodation to increase range and visual comfort which performing activities close to the person. | Behavioural | Office based Vergence and Accommodative Therapy immediately after enrollement |
Primary outcome
Near Point of Convergence with Positive Fusional Vergence
Time frame: after 12 therapy session spanning 6 weeks
Composite score of how close a participant can view a target a single along midline combined with positive fusional vergence range.
2 secondary outcomes
Vergence Peak Velocity
Time frame: after 12 therapy session spanning 6 weeks
Functional Activity within vergence neural circuit
Time frame: after 12 therapy session spanning 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 41033748Alvarez TL, Scheiman M, Hajebrahimi F, Noble M, Gohel S, Baro R, Bachman JA, Master CL, Goodman A; CONCUSS Investigator Group. CONCUSS randomised clinical trial of vergence/accommodative therapy for concussion-related symptomatic convergence insufficiency. Br J Sports Med. 2026 Mar 12;60(5):340-354. doi: 10.1136/bjsports-2025-109807.
- Derived from this study: PubMed 39546477Alvarez TL, Scheiman M, Gohel S, Hajebrahimi F, Noble M, Sangoi A, Yaramothu C, Master CL, Goodman A. Effectiveness of treatment for concussion-related convergence insufficiency: The CONCUSS study protocol for a randomized clinical trial. PLoS One. 2024 Nov 15;19(11):e0314027. doi: 10.1371/journal.pone.0314027. eCollection 2024.
- Individual participant dataSharing planned: Yes. imaging data will be uploaded to FITBIR at the end of the study. Eye movement and clinical data (without any personal identifiers) will be available upon request to the principal investigator (Tara Alvarez, PhD) at the end of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tara L Alvarez, PhD principal investigator
New Jersey Institute of Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Office-based Vergence and Accommodative Therapy in people with Persistent Post-concussive Symptoms and Convergence Insufficiency, run by New Jersey Institute of Technology at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near Point of Convergence with Positive Fusional Vergence (time frame: after 12 therapy session spanning 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05262361, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.