Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rhaeos, Inc.
Study ID
NCT06996600
Status
Recruiting
Apply to this trial

Conditions

  • Hydrocephalus

Eligibility Criteria

Sex
ALL
Age
6 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • wireless thermal anisotropy measurement device — DEVICE
    Wireless wearable thermal anisotropy measurement device designed for use at home

Study Details

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.

Key Dates

Start date
May 2, 2025
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: CSF Shunted Patients with Chronic Headaches
    hydrocephalus patients with an existing ventriculoperitoneal (VP) shunt who experience chronic headaches, defined as ≥15 headache episodes/month for ≥3 months

Primary Outcome Measure

Correlation Between Study Device Flow Measurement and Subject-reported Headaches [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rhaeos, IncChicagoIllinois60642
Anna Somera
[email protected]
855-814-3569

Find similar trials in Chicago, IL

By research site
Rhaeos, Inc· Chicago, IL

Related Studies