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

NCT06129565 | Withdrawn

• 1 other identifier: UKansasQcollarLPH
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Pressure Hydrocephalus

Outcome Measures

Primary Outcomes (2)

• Ventricular drainage

  Amount of ventricular drainage with Q collar treatment

  within 4-6 weeks

• Ventricular size

  change in ventricular size with Q collar treatment

  within 4-6 weeks

Secondary Outcomes (1)

• Change in low-pressure hydrocephalus symptoms

  4-6 weeks

Study Arms (1)

Q-collar Intervention

EXPERIMENTAL

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

Interventions

Q-collar DEVICE

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

Q-collar Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Related Publications (9)

• 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.

  PMID: 21904255 BACKGROUND

• 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.

  PMID: 22998060 BACKGROUND

• 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.

  PMID: 27573472 BACKGROUND

• 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.

  PMID: 32283181 BACKGROUND

• 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.

  PMID: 27307271 BACKGROUND

• 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.

  PMID: 27375546 BACKGROUND

• 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.

  PMID: 34824061 BACKGROUND

• 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.

  PMID: 21800965 BACKGROUND

• 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.

  PMID: 28962963 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: November 13, 2023
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share