uSINE-PAMS Artificial Intelligence Driven, Ultrasound-Guided Lumbar Puncture to Improve Procedural Accuracy

Last updated: May 13, 2024
Sponsor: National Neuroscience Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Intervention Arm (uSINE-PAMS-technique)

Control Arm (traditional landmark-based technique):

Intervention Arm (uSINE-PAMS technique):

Clinical Study ID

NCT05824546
uSINE
  • Ages 21-105
  • All Genders

Study Summary

This study aims to test the effectiveness of uSINE-PAMS technology for lumbar puncture compared to traditional landmark-based technique. uSINE is a machine-learning software designed to aid the operators in ultrasound-guided lumbar puncture while PAMS is a two-part hardware to translate data from ultrasound to accurate needle insertion and angulation.

Eligibility Criteria

Inclusion

INCLUSION CRITERIA:

  • Patients planned for lumbar puncture as part of their clinical care

  • 21 years of age or older

  • Able to provide informed consent

Exclusion

EXCLUSION CRITERIA:

  • Allergy to ultrasound gel

  • Previous lumbar spinal instrumentation

  • Patients with suspected spinal epidural abscess or any other infection at thepotential site of needle entry on the back

  • Possible raised intracranial pressure with risk of cerebral herniation, includingpresence of obstructive hydrocephalus, intracranial space-occupying lesion andcerebral edema

  • Presence of significant thrombocytopenia (platelet <40k) or other bleedingdiathesis; patients on antiplatelet and/or anticoagulation may be included if theirantiplatelet and/or anticoagulation can be and are stopped for an adequate durationprior to lumbar puncture according to the institution guidelines.

Study Design

Total Participants: 50
Treatment Group(s): 3
Primary Treatment: Intervention Arm (uSINE-PAMS-technique)
Phase:
Study Start date:
May 26, 2023
Estimated Completion Date:
July 31, 2024

Study Description

Lumbar puncture (LP) is a routine invasive procedure performed for the diagnosis and treatment of central nervous system disorders. The traditional landmark-based method is associated with a high failure rate of up to 50%, leading to complications including back pain and epidural hematoma, diagnostic delay, and increased healthcare costs. The success rate has been improved with ultrasound guided LP but the use of ultrasound-guided LP has not been widespread due to inadequate training in ultrasound use and the inability to translate information derived from ultrasonography to the LP procedure. uSINE-PAMS was designed to address these challenges: uSINE is a machine-learning software to aid the operators in ultrasound-guided LP; PAMS is a two-part hardware to translate data from ultrasound to accurate needle insertion and angulation.

This study consists of a pilot phase to test the usability of uSINE-PAMs and allow for improvement in technology and clinical workflow for uSINE-PAMS. In the pilot phase, experienced NNI clinicians who have participated in a previous healthy volunteer study and have been trained to use uSINE will be the operators performing the uSINE-PAMS-guided lumbar puncture. During and upon completion of the study, challenges in the use of uSINE and PAMS to conduct LP as well as in the implementation of uSINE-PAMS in the clinical workflow will be determined and addressed prior to the main study, open-label single-arm phase 2 clinical trial. Ten patients will be recruited in this pilot phase.

Following the pilot phase, an open-label single-arm phase 2 clinical trial to test the effectiveness of uSINE-PAMS-guided LP against historical data of 55% from traditional landmark-based method. 50 patients who are planned for LP will be recruited to undergo LP using the uSINE-PAMS-guided technique. The overall hypothesis is that uSINE-PAMS-guided LP will achieve at least 20% improvement in first pass success rate of obtaining cerebrospinal fluid compared to historical data of 55% from traditional landmark-based technique, therefore leading to reduction in complication rates.

Connect with a study center

  • National Neuroscience Institute (NNI)

    Singapore,
    Singapore

    Active - Recruiting

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