Monitoring brain pressure at home for hydrocephalus patients
Wireless HOME Monitoring of Intracranial (BRAIN) PRESSURE
This study is testing a new device that helps people with hydrocephalus monitor their brain pressure at home after surgery to see if it can make their lives easier and reduce hospital visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | University of Auckland, New Zealand Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Auckland) |
| Trial ID | NCT06402786 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety of the Kitea ICP Sensor, which is implanted during shunt surgery for patients with hydrocephalus. The device allows for remote monitoring of intracranial pressure, potentially reducing the need for hospital visits due to shunt failures. The study will recruit 20 participants, including both adults and children, who will use the sensor to measure their brain pressure at home for three months following surgery. The goal is to improve patient outcomes and quality of life by providing caregivers with a reliable tool for monitoring brain pressure.
Who should consider this trial
Good fit: Ideal candidates include individuals aged over 16 years or children aged 1 to 15 years who require shunt placement or revision due to hydrocephalus.
Not a fit: Patients with conditions that prevent compliance with the study protocol or those with terminal illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the management of hydrocephalus by allowing for timely intervention before serious complications arise.
How similar studies have performed: While this approach is novel in humans, previous studies in large animal models have shown promising results regarding the safety and reliability of the device.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with a condition requiring cerebral spinal fluid shunting who are undergoing initial shunt placement or shunt revision surgery. * Adults: Age \> 16 years; Children: Age \>1 and \<15 Exclusion Criteria: * Adults: Unable to give informed consent * Paediatric: Failure to obtain assent in a cognitively competent child along with parental consent or parent unable to consent. * Cortical mantle \< 20 mm * Neurologic or other condition that would prevent compliance with protocol * Terminal illness with expected survival \< 1 year * Unable to participate in follow-up for 3 months (e.g., travelling overseas for an extended period) * Underlying medical condition that would make the participant more prone to surgical infections * Other active implanted medical devices e.g. pacemaker, cochlear implant, implantable cardioverter defibrillator, deep brain stimulation devices * Participants with conditions likely to require radiation therapy
Where this trial is running
Auckland
- Auckland City Hospital — Auckland, New Zealand (Recruiting)
Study contacts
- Principal investigator: Sarah-Jane Guild, PhD — The University of Auckland
- Study coordinator: Sarah-Jane Guild, PhD
- Email: s.guild@auckland.ac.nz
- Phone: +64212969030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.