HydrocephalusNCT02737163
Strata Programmable CSF Shunt Valve Study
An observational study of Hydrocephalus, run by Johns Hopkins All Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Hydrocephalus
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 8 Jun 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
Official title: Inadvertent Cerebral Spinal Fluid Valve Reprogramming: Prevalence and the Correlation With Signs, Symptoms, Radiographic Changes and the Exposure to Magnetic Fields.
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.
Read more
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.
Read the 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.
- Conditions
- Hydrocephalus
- Keywords
- Programmable shunts, Strata valve
- Medical subject headings
- Hydrocephalus
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Encounters With Inadvertent Reprogramming of Strata CSF Shunt Valves.
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.
Measured: 14 months
Secondary outcomes (3)
Number of Encounters/Visits With or Without Valve Changes Due to MRI Field Strengths.
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.
Measured: 14 months
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.
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.
Measured: 14 months
Number of Encounters of Inadvertent Reprogramming With Exposure to Household Devices With Electromagnetic Charge.
Here we report the number of encounter/visits during which valves were inadvertently reprogrammed due to household devices with electromagnetic charge.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start1 Apr 2016
- Primary completion8 Jun 2017
- Study completion8 Jun 2017
Why it stopped: Terminated early due to sufficient data acquired to meet our study objectives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerald Tuite, MD, Principal investigator, Johns Hopkins All Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737163
- Sponsor's protocol ID
- IRB00093490
- Status last verified
- Jun 2023
- First submitted
- 1 Apr 2016
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inadvertent Cerebral Spinal Fluid Valve Reprogramming: Prevalence and the Correlation With Signs, Symptoms, Radiographic Changes and the Exposure to Magnetic Fields.
- ClinicalTrials.gov ID
- NCT02737163
- Acronym / sponsor ID
- IRB00093490
- Conditions
- Hydrocephalus
- Keywords
- Programmable shunts, Strata valve
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated early due to sufficient data acquired to meet our study objectives
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 8 Jun 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Posted 19 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Encounters With Inadvertent Reprogramming of Strata CSF Shunt Valves.
Time frame: 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.
3 secondary outcomes
Number of Encounters/Visits With or Without Valve Changes Due to MRI Field Strengths.
Time frame: 14 months
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.
Time frame: 14 months
Number of Encounters of Inadvertent Reprogramming With Exposure to Household Devices With Electromagnetic Charge.
Time frame: 14 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Gerald Tuite, MD principal investigator
Johns Hopkins All Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus, run by Johns Hopkins All Children's Hospital 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 3 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: stopped early, as of the sponsor's last update on 3 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Encounters With Inadvertent Reprogramming of Strata CSF Shunt Valves. (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2023.