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This study collects exploratory data using a non-invasive device for assessing CSF shunt flow using thermal anisotropy measurements. Patients with an existing implanted ventricular CSF shunt will be enrolled into either a prospective (study device) or retrospective (no study device) cohort to gather data on health resource utilization, quality-of-life, and study device measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSF Shunted Patients | Experimental | The trial will include two cohorts. The study device will be used to assess CSF flow in Cohort A (prospective). The study device will not be used for Cohort B (retrospective). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wireless wearable thermal anisotropy measurement device | Device | non-invasive device used for assessing CSF shunt flow via thermal anisotropy measurements in a routine outpatient clinic setting |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health. A PROMIS T-score of 50 represents the general population norm, and each 10-point deviation represents one standard deviation from the norm. Higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). | 14 days |
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Inclusion criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Neurons Neurosurgical Institute | Cedar Knolls | New Jersey | 07927 | United States |
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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