Ultrasound TherapyNCT05824546
uSINE-PAMS Artificial Intelligence Driven, Ultrasound-Guided Lumbar Puncture to Improve Procedural Accuracy
A study testing Intervention Arm (uSINE-PAMS-technique) in people with Ultrasound Therapy and Lumbar Puncture, run by National Neuroscience Institute at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Ultrasound Therapy, Lumbar Puncture
- What is being tested?
- Intervention Arm (uSINE-PAMS-technique)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 26 May 2023to 31 Jul 2024
- 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 21 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients planned for lumbar puncture as part of their clinical care
- 21 years of age or older
- Able to provide informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Neuroscience Institute (NNI)
Singapore
Xuling Lin, MBBS
About this study
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.
Read the detailed 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.
- Conditions
- Ultrasound Therapy, Lumbar Puncture
- Being tested
- Intervention Arm (uSINE-PAMS-technique)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Arm (uSINE-PAMS-technique)Procedure or surgery
Patients will be lying in a lateral recumbent position and in a fetal position with the neck, back and limbs held in flexion. L3-L4 inter-vertebral space will be identified by palpation of external landmarks of the patients' iliac crests and spinous process of lumbar vertebrae L3, L4 and L5 and confirmed using uSINE-integrated ultrasound. The angle of needle during needle advancement will also be determined using the uSINE-integrated ultrasound. Markings on the patients' skin surface will be made using PAMS (non-sterile component) to enable relocation of the site and angle of the needle entry. Patients' back will be cleaned and draped using aseptic technique. Next, local anaesthesia is infiltrated into the previously identified needle entry site before the LP needle is inserted with location and angulation according to PAMS (sterile component) guidance.
| Study group | Role | What they receive |
|---|---|---|
| uSINE-PAMS-guided | Experimental | Patients will undergo LP using uSINE-PAMS-guided technique Receives: Procedure: Intervention Arm (uSINE-PAMS-technique) |
What is being measured
The primary outcome is the main question the study is designed to answer.
First pass success rate of obtaining CSF using uSINE-PAMS-guided technique against the traditional landmark-based method of 55%.technique against the traditional landmark-based method of 55%.
First pass is defined as the first LP attempt without withdrawing the LP needle out of the skin.
Measured: During procedure
Secondary outcomes (4)
Number of needle redirections using uSINE-PAMS-guided technique.
Needle redirection is defined as the number of times the LP needle was repositioned to obtain the CSF without withdrawing out of the skin.
Measured: During procedure
Rate of traumatic LP using uSINE-PAMS-guided technique.
Traumatic LP is defined as needle-induced blood (>5 red blood cells/ul) in the cerebrospinal fluid; Cases where red blood cells are expected in the cerebrospinal fluid will be excluded from this analysis.
Measured: 1 hour after procedure
Pain score from LP using uSINE-PAMS-guided technique.
Pain score will be assessed using the Universal Pain Assessment Tool which has a scale of 0-10, with 0 being no pain and 10 being Worst Pain Possible.
Measured: Immediately after procedure
Rate of back pain that develops within 24 hours of the LP using uSINE-PAMS-guided technique.
Pain score will be assessed using the Universal Pain Assessment Tool which has a scale of 0-10, with 0 being no pain and 10 being Worst Pain Possible.
Measured: Approximately 24 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start26 May 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ultrasound TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Neuroscience Institute
- Sponsor type
- University, hospital or other
- Collaborators
- HiCura Medical Pte Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824546
- Sponsor's protocol ID
- uSINE
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin X, Lam MLC, Chuang DF, Yuen JYE, Fu L, Jun Zhi Teh V, Marliya A, Saffari SE, Lim CSJ, Wong YL, Seet YHC. uSINE-PAMS Artificial Intelligence-Driven, Ultrasound-Guided Lumbar Puncture to Improve Procedural Accuracy: A Pilot Study Report. Neurol Clin Pract. 2025 Apr;15(2):e200447. doi: 10.1212/CPJ.0000000000200447. Epub 2025 Feb 25.
PubMed 40201070
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- uSINE-PAMS Artificial Intelligence Driven, Ultrasound-Guided Lumbar Puncture to Improve Procedural Accuracy
- ClinicalTrials.gov ID
- NCT05824546
- Acronym / sponsor ID
- uSINE
- Conditions
- Ultrasound Therapy, Lumbar Puncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Neuroscience InstituteUniversity, hospital or other
- Collaborators
- HiCura Medical Pte Ltd
- Study start
- 26 May 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| uSINE-PAMS-guided | Experimental | Procedure: Intervention Arm (uSINE-PAMS-technique)Patients will undergo LP using uSINE-PAMS-guided technique |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients planned for lumbar puncture as part of their clinical care
- 21 years of age or older
- Able to provide informed consent
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Arm (uSINE-PAMS-technique)Patients will be lying in a lateral recumbent position and in a fetal position with the neck, back and limbs held in flexion. L3-L4 inter-vertebral space will be identified by palpation of external landmarks of the patients' iliac crests and spinous process of lumbar vertebrae L3, L4 and L5 and confirmed using uSINE-integrated ultrasound. The angle of needle during needle advancement will also be determined using the uSINE-integrated ultrasound. Markings on the patients' skin surface will be made using PAMS (non-sterile component) to enable relocation of the site and angle of the needle entry. Patients' back will be cleaned and draped using aseptic technique. Next, local anaesthesia is infiltrated into the previously identified needle entry site before the LP needle is inserted with location and angulation according to PAMS (sterile component) guidance. | Procedure or surgery | uSINE-PAMS-guided |
Primary outcome
First pass success rate of obtaining CSF using uSINE-PAMS-guided technique against the traditional landmark-based method of 55%.technique against the traditional landmark-based method of 55%.
Time frame: During procedure
First pass is defined as the first LP attempt without withdrawing the LP needle out of the skin.
4 secondary outcomes
Number of needle redirections using uSINE-PAMS-guided technique.
Time frame: During procedure
Rate of traumatic LP using uSINE-PAMS-guided technique.
Time frame: 1 hour after procedure
Pain score from LP using uSINE-PAMS-guided technique.
Time frame: Immediately after procedure
Rate of back pain that develops within 24 hours of the LP using uSINE-PAMS-guided technique.
Time frame: Approximately 24 hours after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 40201070Lin X, Lam MLC, Chuang DF, Yuen JYE, Fu L, Jun Zhi Teh V, Marliya A, Saffari SE, Lim CSJ, Wong YL, Seet YHC. uSINE-PAMS Artificial Intelligence-Driven, Ultrasound-Guided Lumbar Puncture to Improve Procedural Accuracy: A Pilot Study Report. Neurol Clin Pract. 2025 Apr;15(2):e200447. doi: 10.1212/CPJ.0000000000200447. Epub 2025 Feb 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Arm (uSINE-PAMS-technique) in people with Ultrasound Therapy and Lumbar Puncture, run by National Neuroscience Institute at 1 site in Singapore.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuling Lin, MBBS (63577153, lin.xu.ling@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First pass success rate of obtaining CSF using uSINE-PAMS-guided technique against the traditional landmark-based method of 55%.technique against the traditional landmark-based method of 55%. (time frame: During procedure). 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 NCT05824546, which also lists 1 linked publication.
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 16 May 2024.