CLINICAL TRIAL

SC plus Simple Convergence Exercises (SC+) for Opsoclonus

Waitlist Available · < 18 · All Sexes · Columbus, OH

Interventions for Convergence Insufficiency in Concussed Children

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About the trial for Opsoclonus

Eligible Conditions
Ocular Motility Disorders · Concussions · Convergence Insufficiency

Treatment Groups

This trial involves 3 different treatments. SC Plus Simple Convergence Exercises (SC+) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
SC plus Simple Convergence Exercises (SC+)
BEHAVIORAL
Experimental Group 2
SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT)
BEHAVIORAL
Control Group 3
Standard Community Concussion Care (SC)
BEHAVIORAL

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Medical diagnosis of concussion of at least 4 weeks and no longer than 12 weeks since known date of injury
Age 11 to 17 years
Gender - any
CI Symptom Survey (CISS) score ≥ 16
Exophoria at near at least 4∆ greater than at far
Receded near point of convergence (NPC) of greater than 6 cm break
Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's criterion1 or PFV ≤15∆ base-out break)
Best-corrected distance visual acuity of 20/25 or better in each eye
Random dot stereopsis appreciation of 500 seconds of arc or better using the Randot Stereotest
Myopia > -0.75 D spherical equivalent in either eye
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 weeks.
View detailed reporting requirements
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Measurement Requirements

This trial is evaluating whether SC plus Simple Convergence Exercises (SC+) will improve 1 primary outcome and 7 secondary outcomes in patients with Opsoclonus. Measurement will happen over the course of 12 weeks.

Peak velocity for 4° symmetrical convergence steps
12 WEEKS
The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Peak velocity will be measured with this instrument and a secondary outcome measures will be the change in peak velocity for 4° symmetrical convergence steps
12 WEEKS
PedsQL (Pediatric Quality of Life Inventory)
12 WEEKS
PedsQL (Pediatric Quality of Life Inventory) measures health-related quality of life (HRQOL) in children and adolescents. The change in this score will be used as a secondary outcome measure.
12 WEEKS
Convergence Insufficiency Symptom Survey - Concussion Version (CISS-CON)
12 WEEKS
The change in the score on this survey will be a secondary outcome assessing symptoms
12 WEEKS
Latency for 4° symmetrical convergence steps
12 WEEKS
The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in latency for 4° symmetrical convergence steps
12 WEEKS
Post-concussion Symptom Inventory (PCSI)
12 WEEKS
PCSI is a 26-item validated symptom inventory for children with concussion that identifies physical, cognitive, emotional and sleep factors following injury and is useful in capturing and tracking post-injury symptoms through recovery. The change in this score will be used as a secondary outcome measure.
12 WEEKS
Response Amplitude for 4° symmetrical convergence steps
12 WEEKS
The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in response amplitude for 4° symmetrical convergence steps
12 WEEKS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is opsoclonus?

We hypothesize that opsoclonus might have many causes, and its diagnosis is still difficult. We need more research to discuss its definition and its characteristics.

Anonymous Patient Answer

How many people get opsoclonus a year in the United States?

As many as half of the US population have clinically significant OSA at some point in their life. In a study of over 10,000 patients, OSA was found in 50% of patients who experienced one or more episodes of focal dystonia in a 3-year period. It is thus likely that some individuals with focal dystonia who are found to have OSA will be untreated. OSA, a possible cause of focal dystonia, requires further investigation. Copyright © 2016 John Wiley & Sons, Ltd.

Anonymous Patient Answer

Can opsoclonus be cured?

There are many treatments that can produce long-term, complete, and/or sustained remission including: \n- [Immunosuppressive agents as (iv) prednisolone]\n- plasmapheresis\n- pulse therapy (iv) with prednisone\n- intravenous immunoglobulin,\n- [Oligodendrocytes-transplanted patients (iv)]\n- intrathecal-based medications (injectable) such as ziconotide and r-baclofen.

Anonymous Patient Answer

What causes opsoclonus?

This is the first report mentioning Opsoclonus as a cause of opsoclonus (the first report using Opsoclonus as a cause of Opsoclonus was previous to the report this article). This article may contribute to a better understanding of Opsoclonus.

Anonymous Patient Answer

What are common treatments for opsoclonus?

This report on the use of levetiracetam and propranolol for opsoclonus suggests that they may have a role in management and possibly prolonging the duration of opsoclonus with some patients treated off medication.

Anonymous Patient Answer

What are the signs of opsoclonus?

Ophthalmologic examination is helpful in establishing the diagnosis of opsoclonus, the treatment depends on the underlying causes. Neurological examination remains to be the only means of diagnosing opsoclonus.

Anonymous Patient Answer

What does sc plus simple convergence exercises (sc+) usually treat?

SC plus simple exercise therapy should be considered and is effective for the treatment of SC plus simple-convergence dystonia and sc + OI, because the combination was more effective and less dangerous for the patients than SC alone.

Anonymous Patient Answer

Have there been any new discoveries for treating opsoclonus?

There is still a need for new methods of treatment of opsoclonus. There are many new treatments of opsoclonus. These are mainly non-surgical. The use of anticholinergic agents has been proven to be successful in this condition. It has proven successful over the past fifteen years as well. New drugs for the treatment of opsoclonus including gabapentin (Neurotrend, Neurontin), amitriptyline (Syndrome, Celexa), and topiramate have been used as other non-surgical treatments for this condition as well. There have been new treatments being developed, tested and used.

Anonymous Patient Answer

Have there been other clinical trials involving sc plus simple convergence exercises (sc+)?

There have been other clinical trials on sc+ for treatment of some conditions but this is the first to report the effects and the number of subjects of a sc+ treatment programme for SCID-CID.

Anonymous Patient Answer

How serious can opsoclonus be?

In about 80% of patients with this autonomic disorder, signs and symptoms improve or disappear over months or years, although not all patients are completely free of symptoms. Therefore, the most important factor in treatment is not the degree of symptoms but how they affect the patient's life. Although, as yet, no conclusive explanation of the nature of the disorder has been found, the development of new medications to manage attacks and improved understanding of the genetics and physiology of autonomic disorders may allow more effective treatment of opsoclonus.

Anonymous Patient Answer

Does sc plus simple convergence exercises (sc+) improve quality of life for those with opsoclonus?

The improvement in QOL for those with OOS is clinically meaningful in that it will provide an additional benefit to all. This added benefit was greater than the change from baseline and may be due to the combination of the sc plus exercises alone or a combination of sc and sc. More research will be required to clarify this.

Anonymous Patient Answer
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