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Low Pressure HydrocephalusNCT06129565

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

A study testing Q-collar in people with Low Pressure Hydrocephalus, run by University of Kansas Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low Pressure Hydrocephalus
What is being tested?
Q-collar
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2024to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

About this study

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.

Read the 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.

Being tested
Q-collar
Medical subject headings
Hydrocephalus, Normal Pressure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Q-collarDevice

    Q-collar is placed for all patients that are admitted with low-pressure hydrocephalus

Study groups in NCT06129565
Study groupRoleWhat they receive
Q-collar InterventionExperimentalAll patients with low-pressure hydrocephalus that qualify for the study and agree to participate will receive the Q-collar for intervention
Receives: Device: Q-collar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ventricular drainage

    Amount of ventricular drainage with Q collar treatment

    Measured: within 4-6 weeks

  2. Ventricular size

    change in ventricular size with Q collar treatment

    Measured: within 4-6 weeks

Secondary outcomes (1)

  1. Change in low-pressure hydrocephalus symptoms

    Patients surveyed daily regarding low-pressure hydrocephalus symptoms including headache, altered mental status, blurry vision, other. Will document if worse, unchanged, or improved.

    Measured: 4-6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study startDec 2024 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Why it stopped: Participants not enrolled due to interest in the project

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06129565
Sponsor's protocol ID
UKansasQcollarLPH
Status last verified
Jul 2025
First submitted
3 Oct 2023
Last updated
8 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Smith DW, Bailes JE, Fisher JA, Robles J, Turner RC, Mills JD. Internal jugular vein compression mitigates traumatic axonal injury in a rat model by reducing the intracranial slosh effect. Neurosurgery. 2012 Mar;70(3):740-6. doi: 10.1227/NEU.0b013e318235b991.

    PubMed 21904255

  • Turner RC, Naser ZJ, Bailes JE, Smith DW, Fisher JA, Rosen CL. Effect of slosh mitigation on histologic markers of traumatic brain injury: laboratory investigation. J Neurosurg. 2012 Dec;117(6):1110-8. doi: 10.3171/2012.8.JNS12358. Epub 2012 Sep 21.

    PubMed 22998060

  • Sindelar B, Bailes J, Sherman S, Finan J, Stone J, Lee J, Ahmadian S, Zhou Y, Patel V, Smith D. Effect of Internal Jugular Vein Compression on Intracranial Hemorrhage in a Porcine Controlled Cortical Impact Model. J Neurotrauma. 2017 Apr 15;34(8):1703-1709. doi: 10.1089/neu.2016.4648. Epub 2016 Dec 16.

    PubMed 27573472

  • Mannix R, Morriss NJ, Conley GM, Meehan WP 3rd, Nedder A, Qiu J, Float J, DiCesare CA, Myer GD. Internal Jugular Vein Compression Collar Mitigates Histopathological Alterations after Closed Head Rotational Head Impact in Swine: A Pilot Study. Neuroscience. 2020 Jun 15;437:132-144. doi: 10.1016/j.neuroscience.2020.04.009. Epub 2020 Apr 10.

    PubMed 32283181

  • Myer GD, Yuan W, Barber Foss KD, Thomas S, Smith D, Leach J, Kiefer AW, Dicesare C, Adams J, Gubanich PJ, Kitchen K, Schneider DK, Braswell D, Krueger D, Altaye M. Analysis of head impact exposure and brain microstructure response in a season-long application of a jugular vein compression collar: a prospective, neuroimaging investigation in American football. Br J Sports Med. 2016 Oct;50(20):1276-1285. doi: 10.1136/bjsports-2016-096134. Epub 2016 Jun 15.

    PubMed 27307271

  • Myer GD, Yuan W, Barber Foss KD, Smith D, Altaye M, Reches A, Leach J, Kiefer AW, Khoury JC, Weiss M, Thomas S, Dicesare C, Adams J, Gubanich PJ, Geva A, Clark JF, Meehan WP 3rd, Mihalik JP, Krueger D. The Effects of External Jugular Compression Applied during Head Impact Exposure on Longitudinal Changes in Brain Neuroanatomical and Neurophysiological Biomarkers: A Preliminary Investigation. Front Neurol. 2016 Jun 6;7:74. doi: 10.3389/fneur.2016.00074. eCollection 2016.

    PubMed 27375546

  • Dinsmore M, Hajat Z, Brenna CT, Fisher J, Venkatraghavan L. Effect of a neck collar on brain turgor: a potential role in preventing concussions? Br J Sports Med. 2022 Jun;56(11):605-607. doi: 10.1136/bjsports-2021-103961. Epub 2021 Nov 25.

    PubMed 34824061

  • Filippidis AS, Kalani MY, Nakaji P, Rekate HL. Negative-pressure and low-pressure hydrocephalus: the role of cerebrospinal fluid leaks resulting from surgical approaches to the cranial base. J Neurosurg. 2011 Nov;115(5):1031-7. doi: 10.3171/2011.6.JNS101504. Epub 2011 Jul 29.

    PubMed 21800965

  • Strand A, Balise S, Leung LJ, Durham S. Low-Pressure Hydrocephalus: A Case Report and Review of the Literature. World Neurosurg. 2018 Jan;109:e131-e135. doi: 10.1016/j.wneu.2017.09.120. Epub 2017 Sep 28.

    PubMed 28962963

Questions about this trial

What is this clinical trial studying?

A study testing Q-collar in people with Low Pressure Hydrocephalus, run by University of Kansas Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ventricular drainage (time frame: within 4-6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06129565, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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