Using AI and ultrasound to improve lumbar puncture accuracy
uSINE-PAMS Artificial Intelligence Driven, Ultrasound-Guided Lumbar Puncture to Improve Procedural Accuracy
This study is testing a new technology that uses AI and ultrasound to see if it can make lumbar punctures more accurate and safer for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 105 Years |
| Sex | All |
| Sponsor | National Neuroscience Institute Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT05824546 on ClinicalTrials.gov |
What this trial studies
This study tests the effectiveness of the uSINE-PAMS technology for performing lumbar punctures compared to traditional methods. The uSINE component is a machine-learning software that assists operators during the procedure, while PAMS is hardware that helps translate ultrasound data for precise needle insertion. The study includes a pilot phase where trained clinicians will use this technology to identify challenges and improve clinical workflow before a larger trial. The goal is to enhance the success rate of lumbar punctures and reduce complications associated with the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who require a lumbar puncture as part of their clinical care.
Not a fit: Patients with allergies to ultrasound gel, previous spinal instrumentation, or conditions that increase the risk of complications from lumbar puncture may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could significantly reduce the failure rate and complications of lumbar punctures, leading to better patient outcomes.
How similar studies have performed: While ultrasound-guided lumbar puncture has shown promise in improving success rates, the specific use of uSINE-PAMS technology is a novel approach that has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 CRITERIA: * Allergy to ultrasound gel * Previous lumbar spinal instrumentation * Patients with suspected spinal epidural abscess or any other infection at the potential site of needle entry on the back * Possible raised intracranial pressure with risk of cerebral herniation, including presence of obstructive hydrocephalus, intracranial space-occupying lesion and cerebral edema * Presence of significant thrombocytopenia (platelet \<40k) or other bleeding diathesis; patients on antiplatelet and/or anticoagulation may be included if their antiplatelet and/or anticoagulation can be and are stopped for an adequate duration prior to lumbar puncture according to the institution guidelines.
Where this trial is running
Singapore
- National Neuroscience Institute (NNI) — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Xuling Lin, MBBS
- Email: lin.xu.ling@singhealth.com.sg
- Phone: 63577153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.