Concussion, BrainNCT04076657
Efficacy of Brock String Therapy Post Concussion
A study testing Brock String Therapy in people with Concussion, Brain and Near Point Convergence, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of the proposed study is to evaluate the efficacy of Brock String therapy prescribed in the acute stage of concussion recovery can improve clinical outcomes among patients with receded near point of convergence (NPC). Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Concussion, Brain, Near Point Convergence
- What is being tested?
- Brock String Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 19 Mar 2025
- 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 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Athletes who sustained a concussion during organized sport within past 48 hours
- ages 12-20
- at least one NPC measurement >10 centimeters at initial clinic evaluation.
Who cannot join
- lack of access to a smart phone to receive text message prompts
- vestibular disorder
- seizure disorder
- history of traumatic brain injury with imaging findings or brain surgery
- history of 3+ concussions\
- concussion within the past 6 months
Show all 9Show fewer
- history of developmental or intellectual disability
- history of substance abuse
- Patients will also be excluded from recruitment if the treating clinician feels the potential participant would be unable to tolerate Brock String therapy due to severe symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center, Rooney Sports Complex
Pittsburgh, Pennsylvania, 15203
About this study
Official title: Brock String Therapy for Receded Near Point of Convergence Post Concussion
The purpose of the proposed study is to evaluate the efficacy of Brock String therapy prescribed in the acute stage of concussion recovery can improve clinical outcomes among patients with receded near point of convergence (NPC).
Aim 1: Determine if participants receiving the Brock String have more significant improvements in NPC measurements at follow up 7-10 days post injury.
Aim 2: Determine if participants receiving the Brock String 1) improve on computerized neurocognitive test scores from initial visit (<48 hours post injury) to follow up visit (7-10 days post injury) compared to control participants, and 2) have reduced recovery time (i.e., days from injury until return to play) compared to control participants.
Read the detailed description
Receded near point of convergence (NPC) is a common oculomotor deficit associated with numerous vision diagnoses, including convergence and accommodative insufficiencies, following sport-related concussion (SRC). Researchers have found associations with worse neurocognitive test scores, higher post-concussion symptom burden, and longer recovery among patients with receded NPC relative to concussion patients with normal NPC. Although oculomotor dysfunction may resolve spontaneously or improves with vision therapy exercises in the post-acute phase of recovery, it is unclear if early intervention can improve recovery outcomes. The Brock String is a cost effective and practical vision therapy exercise for congenital convergence insufficiency (CI), and initial research supports effectiveness with SRC patients who have receded NPC in the subacute phase of recovery (e.g., weeks to months post injury). Early vision therapy intervention may be efficacious in improving recovery times and reduce healthcare costs by eliminating later therapies for chronic deficits.
- Conditions
- Concussion, Brain, Near Point Convergence
- Being tested
- Brock String Therapy, Standard of Care
- Keywords
- brock string, sport-concussion, concussion therapy, receded near point of convergence
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brock String TherapyBehavioural
Oculomotor exercise to improve binocular vision function
Standard of CareBehavioural
patient engages in normal behavior to manage vision issues, such as breaks with reading and screen use
| Study group | Role | What they receive |
|---|---|---|
| Brock String | Experimental | Participants will receive instruction on Brock String therapy after first clinic visit (<48 hours post) injury, and will complete home therapy exercise twice daily Receives: Behavioral: Brock String Therapy |
| Standard of Care | Active comparator | Participants will receive standard of care (i.e., no Brock String therapy within the first week post injury) but will be informed they will receive any therapy deemed necessary at follow up visit 7-10 days post injury, consistent with standard of care Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near point of convergence measurement
change in convergence measurement from nose in centimeters
Measured: from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)
Secondary outcomes (2)
Immediate Post Concussion Assessment and Cognitive Testing (ImPACT
change in test scores based on normative data percentile (range <1-100); for all composite scores, including verbal memory, visual memory, visual motor speed scores, reaction time; better score indicating better performance
Measured: from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)
concussion recovery duration
recovery time (i.e., days from injury until return to play)
Measured: from day of injury until final clinic visit, determined by concussion symptoms resolving and all aspects of testing within normal limits; expected range 7-10 days to up to 6 months post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start9 Nov 2020
- Primary completion19 Mar 2025
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alicia Trbovich, University of Pittsburgh
- Investigators
- Alicia Trbovich, PhD, Principal investigator, University of PittsburghAnthony P Kontos, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076657
- Sponsor's protocol ID
- STUDY19070375
- Status last verified
- Jun 2025
- First submitted
- 27 Aug 2019
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trbovich AM, Zynda AJ, Togashi T, Burley C, Mucha A, Collins MW, Kontos AP. Randomized Controlled Trial of Brock String Vision Therapy for Receded Near Point of Convergence Following Concussion. J Neurotrauma. 2025 Oct;42(19-20):1708-1718. doi: 10.1177/08977151251359960. Epub 2025 Sep 16.
PubMed 40957852
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brock String Therapy for Receded Near Point of Convergence Post Concussion
- ClinicalTrials.gov ID
- NCT04076657
- Acronym / sponsor ID
- STUDY19070375
- Conditions
- Concussion, Brain, Near Point Convergence
- Keywords
- brock string, sport-concussion, concussion therapy, receded near point of convergence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 3 Sep 2019 (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.
The purpose of the proposed study is to evaluate the efficacy of Brock String therapy prescribed in the acute stage of concussion recovery can improve clinical outcomes among patients with receded near point of convergence (NPC).
Aim 1: Determine if participants receiving the Brock String have more significant improvements in NPC measurements at follow up 7-10 days post injury.
Aim 2: Determine if participants receiving the Brock String 1) improve on computerized neurocognitive test scores from initial visit (<48 hours post injury) to follow up visit (7-10 days post injury) compared to control participants, and 2) have reduced recovery time (i.e., days from injury until return to play) compared to control participants.
Detailed description
Receded near point of convergence (NPC) is a common oculomotor deficit associated with numerous vision diagnoses, including convergence and accommodative insufficiencies, following sport-related concussion (SRC). Researchers have found associations with worse neurocognitive test scores, higher post-concussion symptom burden, and longer recovery among patients with receded NPC relative to concussion patients with normal NPC. Although oculomotor dysfunction may resolve spontaneously or improves with vision therapy exercises in the post-acute phase of recovery, it is unclear if early intervention can improve recovery outcomes. The Brock String is a cost effective and practical vision therapy exercise for congenital convergence insufficiency (CI), and initial research supports effectiveness with SRC patients who have receded NPC in the subacute phase of recovery (e.g., weeks to months post injury). Early vision therapy intervention may be efficacious in improving recovery times and reduce healthcare costs by eliminating later therapies for chronic deficits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brock String | Experimental | Behavioral: Brock String TherapyParticipants will receive instruction on Brock String therapy after first clinic visit (<48 hours post) injury, and will complete home therapy exercise twice daily |
| Standard of Care | Active comparator | Behavioral: Standard of CareParticipants will receive standard of care (i.e., no Brock String therapy within the first week post injury) but will be informed they will receive any therapy deemed necessary at follow up visit 7-10 days post injury, consistent with standard of care |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Athletes who sustained a concussion during organized sport within past 48 hours
- ages 12-20
- at least one NPC measurement >10 centimeters at initial clinic evaluation.
Key exclusion criteria (9 listed)
- lack of access to a smart phone to receive text message prompts
- vestibular disorder
- seizure disorder
- history of traumatic brain injury with imaging findings or brain surgery
- history of 3+ concussions\
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 |
|---|---|---|
| Brock String TherapyOculomotor exercise to improve binocular vision function | Behavioural | Brock String |
| Standard of Carepatient engages in normal behavior to manage vision issues, such as breaks with reading and screen use | Behavioural | Standard of Care |
Primary outcome
Near point of convergence measurement
Time frame: from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)
change in convergence measurement from nose in centimeters
2 secondary outcomes
Immediate Post Concussion Assessment and Cognitive Testing (ImPACT
Time frame: from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)
concussion recovery duration
Time frame: from day of injury until final clinic visit, determined by concussion symptoms resolving and all aspects of testing within normal limits; expected range 7-10 days to up to 6 months post injury
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 5 Jun 2025.
- Derived from this study: PubMed 40957852Trbovich AM, Zynda AJ, Togashi T, Burley C, Mucha A, Collins MW, Kontos AP. Randomized Controlled Trial of Brock String Vision Therapy for Receded Near Point of Convergence Following Concussion. J Neurotrauma. 2025 Oct;42(19-20):1708-1718. doi: 10.1177/08977151251359960. Epub 2025 Sep 16.
- Individual participant dataSharing planned: No
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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.
Alicia Trbovich, PhD principal investigator
University of Pittsburgh
Anthony P Kontos, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brock String Therapy in people with Concussion, Brain and Near Point Convergence, run by University of Pittsburgh at 1 site 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 3 inclusion and 9 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 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 measurement (time frame: from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)). 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 NCT04076657, which also lists 1 linked publication.
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 5 Jun 2025.