The Use of Q-Collar to Increase CSF Drainage in Low-pressure Hydrocephalus Patients

May 9, 2024 updated by: Paul Camarata, MD, University of Kansas Medical Center
The investigators hypothesize that the Q-collar compression on bilateral internal jugular veins of patients with low pressure hydrocephalus will decrease venous drainage from the intracranial space, therefore increasing intracranial volume, decreasing brain compliance, and increasing CSF drainage through the shunt. This should improve persistent hydrocephalus symptoms and demonstrate improved ventricular drainage on imaging with decompressed ventricles.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Low-pressure hydrocephalus is an entity that is rare and difficult to manage. At this institution, Dr. Paul Camarata uses a method of "neck-wrapping" in those low-pressure hydrocephalus patients that were admitted for complications with their shunt, hypothesized to decrease venous outflow from the intracranial space, increase venous pressure within the cranium and therefore increase the turgor in the brain tissue allowing for CSF to more easily be pushed out of the ventricular space and through the drain. This would relieve the hydrocephalus symptoms and reduce ventricular size on imaging. The advent of the Q-collar for reducing TBI in contact sports functions in a similar way to the "neck-wrapping" used at this institution, but via the simplified tool of the collar. It functions by compressing the internal jugular veins bilaterally to increase intracranial volume and prevent "brain slosh" that can occur in contact sports that leads to brain injury. The collar in contrast to the neck wrap occupies a smaller surface area, which the investigators hypothesize will reduce the discomfort that is commonly associated with neck wrap. Furthermore, applying this Q-collar to low pressure hydrocephalus patients that struggle with symptom management while inpatient, the investigators hypothesize that CSF drainage will improve with wearing the collar via increased intracranial volume and lower brain compliance, therefore improving persistent hydrocephalus symptoms that are limiting on patient quality of life.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adult with low-pressure hydrocephalus, able to cranial imaging, able to provide consent or have surrogate decision maker that is able to provide it for them

Exclusion Criteria:

  • pediatric patients, patients that can't consent or don't have a surrogate decision maker, patients that can't get cranial imaging

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Q-collar Intervention
All patients with low-pressure hydrocephalus that qualify for the study and agree to participate will receive the Q-collar for intervention
Device: Q-collar
Q-collar is placed for all patients that are admitted with low-pressure hydrocephalus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventricular drainage
Time Frame: within 4-6 weeks
Amount of ventricular drainage with Q collar treatment
within 4-6 weeks
Ventricular size
Time Frame: within 4-6 weeks
change in ventricular size with Q collar treatment
within 4-6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in low-pressure hydrocephalus symptoms
Time Frame: 4-6 weeks
Patients surveyed daily regarding low-pressure hydrocephalus symptoms including headache, altered mental status, blurry vision, other. Will document if worse, unchanged, or improved.
4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 3, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKansasQcollarLPH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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