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

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06129565

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Low Pressure Hydrocephalus	Device: Q-collar	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Ventricular drainage [within 4-6 weeks]
Amount of ventricular drainage with Q collar treatment
Ventricular size [within 4-6 weeks]
change in ventricular size with Q collar treatment

Secondary Outcome Measures

Change in low-pressure hydrocephalus symptoms [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Paul Camarata, MD, Chairman, Department of Neurosurgery, University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT06129565

Other Study ID Numbers:

UKansasQcollarLPH

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hydrocephalus

Hydrocephalus, Normal Pressure

Study Results

No Results Posted as of Nov 13, 2023