NCT02737163

Strata Programmable CSF Shunt Valve Study

Terminated Results posted Last updated 3 July 2023

What this trial tests

trial in Hydrocephalus in 95 participants. Terminated before completion.

Timeline

1 April 2016

Primary endpoint
8 June 2017

8 June 2017

Quick facts

Lead sponsor	Johns Hopkins All Children's Hospital
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	95
Start date	1 April 2016
Primary completion	8 June 2017
Estimated completion	8 June 2017
Sites	1 location across United States

Conditions studied

• Hydrocephalus — all drugs for Hydrocephalus →

Sponsor

Johns Hopkins All Children's Hospital

Who can join

Adults 1 to 21, any sex, with Hydrocephalus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Encounters With Inadvertent Reprogramming of Strata CSF Shunt Valves. Primary · 14 months

Assessed by checking the valves at routine follow-up visits, in patient hospitalizations and prior to MRI imaging. The frequency will be calculated by the number of encounters/visits during which an assessed valve was inadvertently reprogrammed divided by the total number of encounters/visits in the trial. Here, we report the number of encounters/visits during which valves were inadvertently reprogrammed.

Group	Value	95% CI
Observational Single Ecounter Assessment	15

Number of Encounters/Visits With or Without Valve Changes Due to MRI Field Strengths. Secondary · 14 months

Shunt valve settings were assessed before and after MRI studies using the 1.5 Tesla (T), 3 Tesla (T) or other MRI field strengths for any valve setting changes.

1.5 T MRI valve changes

Group	Value	95% CI
Observational Single Ecounter Assessment	76
Observational Single Ecounter Assessment	15

3T MRI valve changes

Group	Value	95% CI
Observational Single Ecounter Assessment	78
Observational Single Ecounter Assessment	13

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. Secondary · 14 months

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 Assessment will be made using a family questionnaire and data sheet from clinical evaluation.

Group	Value	95% CI
Observational Single Ecounter Assessment	7

Number of Encounters of Inadvertent Reprogramming With Exposure to Household Devices With Electromagnetic Charge. Secondary · 14 months

Here we report the number of encounter/visits during which valves were inadvertently reprogrammed due to household devices with electromagnetic charge.

Group	Value	95% CI
Observational Single Ecounter Assessment	15

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Current State of Clinical Trials Studying Hydrocephalus: An Analysis of ClinicalTrials.gov.
   Abraham ME, Povolotskiy R, Gold J, Ward M, et al · · 2020 · cited 3× · PMID 32983722 · DOI 10.7759/cureus.10029