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This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during headache and non-headache periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSF Shunted Patients with Chronic Headaches | Experimental | hydrocephalus patients with an existing ventriculoperitoneal (VP) shunt who experience chronic headaches, defined as ≥15 headache episodes/month for ≥3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wireless thermal anisotropy measurement device | Device | Wireless wearable thermal anisotropy measurement device designed for use at home |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Study Device Flow Measurement and Subject-reported Headaches | Exploratory analysis to determine the relationship between headaches (subject-reported headache and non-headache periods) and measured flow. Data will be analyzed using the Point-Biserial Correlation Coefficient between headaches periods (headache and non-headache periods) and thermal flow score (flow score derived from algorithm analysis of raw thermal data) | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Somera | Contact | 855-814-3569 | clinical@rhaeos.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhaeos, Inc | Recruiting | Chicago | Illinois | 60642 | 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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