Clinical trial NCT02737163: Strata Programmable CSF Shunt Valve Study
Official title: Inadvertent Cerebral Spinal Fluid Valve Reprogramming: Prevalence and the Correlation With Signs, Symptoms, Radiographic Changes and the Exposure to Magnetic Fields.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hydrocephalus
Keywords: Programmable shunts
Strata valve
Lead sponsor: Johns Hopkins All Children's Hospital
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 95
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 21 years of age and younger, with Strata valve CSF shunts, who are being evaluated by the All Children's Hospital (ACH) neurosurgical service as part of standard of care, will be eligible for participation during the three-year enrollment period. Each time an eligible patient has contact with the neurosurgical service their valve will be checked for possible inadvertent reprogramming in the outpatient facilities, emergency department, and inpatient setting. Patients will only have their valves checked as part of this study once during each encounter. Only patients who were evaluated by the neurosurgical service and returned to their normal environment more than seven days prior to their current encounter will be eligible to have their valves rechecked as part of this study.

Brief summary: The treatment of hydrocephalus is the most time consuming, and arguably the most important role of the pediatric neurosurgical service at most children's' hospitals. Despite many technological advances, cerebral spinal fluid (CSF) shunting procedures remain the mainstay of hydrocephalus treatment. While often lifesaving, CSF shunting procedures are associated with high complication rates and account for a disproportionate share of health care expenditures and morbidity.

Programmable CSF shunt valves, through which CSF flow and pressure can be adjusted by quick and painless transcutaneous reprogramming, have been implanted for more than 15 years in the developed world. Reprogramming these valves relies on rotational magnetic forces, which are applied by neurosurgeons and neurosurgical advanced practice providers. Inadvertent reprogramming (IR) can occur when patients with these valves are exposed to magnetic fields in the environment, which may lead to serious symptoms that may require urgent reprogramming and/or surgery.

The concurrent proliferation of magnetically sensitive programmable CSF shunt valves and household items that generate substantial magnetic fields has caused concern among patients, parents and providers about the potential consequences of inadvertent valve reprogramming. This growing concern led the FDA to issue a warning to individuals with programmable valves in 2014, which deemed the programmable valves safe for use but vulnerable to IR when household devices such as tablets or cell phones are placed within 2 inches of the valve. The FDA recommended further study, stating that no systematic evaluation had been performed regarding the prevalence of accidental valve adjustments.

By evaluating each of the patients with magnetically susceptible CSF shunt valves, during each of the routine points of contact with the service, investigators aim to define the prevalence of inadvertent shunt reprogramming, to correlate with the presence and absence of symptoms and radiographic changes, and to evaluate the risk of inadvertent shunt reprogramming based on exposure to common environmental items.

Detailed description: Investigators intend to evaluate all patients 21 years old and younger with magnetically susceptible CSF shunts, specifically those with Strata (Medtronic, Dublin) valves implanted. All evaluations will be performed during routine patient care in the hospital, the emergency department and in the outpatient facilities. Valve settings will be checked transcutaneously in the standard manner, before and after any MRI studies.

Evaluating IR and making correlations between exposure to MRI or environmental magnets and symptoms and radiographic changes (when available) will require the patient or family to complete a brief questionnaire. It will then require the study team and delegated providers to check the valve setting before and after MRI, and to gather clinical information from the medical record and from the current clinical evaluation.

Each patient's initial enrollment will require the acquisition of an informed consent, which will cover all future evaluations of IR during the three year study period for that patient. However, every time a patient enrolled in the study encounters the neurosurgical service, all study steps will be performed, including the valve check before and after MRI, the participant's completion of the questionnaire, and the research staff's completion of the data sheets.

Eligibility criteria: Inclusion Criteria:

* Patients 21 years of age and younger
* With Strata valve CSF shunts
* Who are being evaluated by the All Children's Hospital (ACH) neurosurgical service as part of standard of care

Exclusion Criteria:

* Patients older than 21 years of age
* Do not have a Strata CSF shunt valve
* Not patients of the All Children's Hospital neurosurgical service

Primary outcomes:
measure: Number of Encounters With Inadvertent Reprogramming of Strata CSF Shunt Valves.
timeFrame: 14 months
Secondary outcomes:
measure: Number of Encounters/Visits With or Without Valve Changes Due to MRI Field Strengths.
timeFrame: 14 months
measure: Number of Encounters With Increased Signs, Symptoms and Radiographic Changes Suggestive of Shunt Malfunction in Participants With Inadvertent Reprogramming of the Strata Valve Compared to Those Without Inadvertent Reprogramming.
timeFrame: 14 months
measure: Number of Encounters of Inadvertent Reprogramming With Exposure to Household Devices With Electromagnetic Charge.
timeFrame: 14 months
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
Study officials:
affiliation: Johns Hopkins All Children's Hospital
name: Gerald Tuite, MD
role: PRINCIPAL_INVESTIGATOR
References: