Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05262361
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2022-02-21
Brief Title:
Persistent Post-Concussion Symptoms With Convergence Insufficiency
Sponsor:
New Jersey Institute of Technology
Organization:
New Jersey Institute of Technology
Study Overview
Official Title:
Functional Mechanism of Neural Control in Persistent Post-Concussion Symptoms Convergence Insufficiency
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPCS-CI
Brief 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 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 34 to 1275-11 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 schoolsports 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2R01EY023261 | NIH | None | httpsreporternihgovquickSearch2R01EY023261 |