Lumbar PunctureAPLOSIMNCT05269238
Improvement of the Performance of Lumbar Punctures After Training Students With an Augmented Reality SIMulator
A study testing performing lumbar punctures by students with standard training and training students augmented reality simulator in people with Lumbar Puncture, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Lumbar punctures (LP) are frequent invasive procedures that are anxiety-provoking for both the patient and the clinicans performing the procedure. LP is performed by many practitioners, whether they are emergency physicians, neurologists, neurosurgeons, internists or rheumatologists. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Puncture
- What is being tested?
- performing lumbar punctures by students with standard training and training students augmented reality simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2021to 15 Nov 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Requiring a lumbar puncture as part of their routine care
- Male or female of legal age with no upper age limit
- French speaking
- Subject affiliated to a social health insurance scheme
- Not having expressed his or her opposition to the re-use of his or her data in the context of this research
Who cannot join
- Previously undergone a lumbar puncture
- BMI > 35 kg/m².
- Spinal ankylosis: history of ankylosing spondylitis or Forestier's disease
- Impossible to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
- Subject under court protection
- Subject under guardianship or curatorship
- Contraindication to the use of Emlapatch
Trial locations and contacts
1 site in 1 country.
About this study
Lumbar punctures (LP) are frequent invasive procedures that are anxiety-provoking for both the patient and the clinicans performing the procedure. LP is performed by many practitioners, whether they are emergency physicians, neurologists, neurosurgeons, internists or rheumatologists. Learning how to perform LP is essentially done at the patient's bed by showing the students how a procedure is performed and then having them perform it directly on a patient afterwards. The recent development of simulation in health care with the credo "never the first time on the patient" requires the development of training devices faithful to reality.
The rheumatology department of the Strasbourg University Hospital has been working for 3 years, in collaboration with the Strasbourg start-up InSimo, on the development of an LP simulator. This simulator is original because it allows the feeling by pressure of the passage of the various structures, and in particular the yellow ligament. This sensation is made possible by a haptic force feedback device.
- Conditions
- Lumbar Puncture
- Being tested
- performing lumbar punctures by students with standard training, training students augmented reality simulator
- Keywords
- lumbar puncture, simulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
performing lumbar punctures by students with standard trainingOther
performance of the puncture by the student have been previously trained with standard training
training students augmented reality simulatorOther
performance of the puncture by the student have been previously trained using the augmented reality simulator
| Study group | Role | What they receive |
|---|---|---|
| control group patient | Other | performing lumbar punctures by students with standard training Receives: Other: performing lumbar punctures by students with standard training |
| experimental group patient | Experimental | performing lumbar punctures by students with standard training and an augmented reality simulator Receives: Other: training students augmented reality simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of lumbar punctures in patients according to whether the students performing their first lumbar puncture were previously trained to perform this invasive procedure using the augmented reality simulator versus standard teaching.
Success rate of lumbar puncture as assessed by the collection of cerebrospinal fluid (CSF) at the end of the procedure. A successful LP is defined as the collection of CSF at the end of the procedure performed by the student without the assistance of a senior physician or resident and without interruption of the procedure by the patient.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start2 Dec 2021
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
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 Lumbar PunctureStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269238
- Sponsor's protocol ID
- 8074
- Acronym
- APLOSIM
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2022
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Felten R, Bigaut K, Wirth T, Kremer L, Gauer L, Arnold C, Ollivier I, Godet J, Scherlinger M, Dubois M, Sebbag E, De Seze J, Gottenberg JE. Advancing medical training with augmented reality and haptic feedback simulator: outcomes of a randomized controlled trial on lumbar puncture. BMC Med Educ. 2025 Aug 30;25(1):1231. doi: 10.1186/s12909-025-07536-6.
PubMed 40885925
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of the Performance of Lumbar Punctures After Training Students With an Augmented Reality SIMulator
- ClinicalTrials.gov ID
- NCT05269238
- Acronym / sponsor ID
- APLOSIM / 8074
- Conditions
- Lumbar Puncture
- Keywords
- lumbar puncture, simulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 7 Mar 2022 (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.
Lumbar punctures (LP) are frequent invasive procedures that are anxiety-provoking for both the patient and the clinicans performing the procedure. LP is performed by many practitioners, whether they are emergency physicians, neurologists, neurosurgeons, internists or rheumatologists. Learning how to perform LP is essentially done at the patient's bed by showing the students how a procedure is performed and then having them perform it directly on a patient afterwards. The recent development of simulation in health care with the credo "never the first time on the patient" requires the development of training devices faithful to reality.
The rheumatology department of the Strasbourg University Hospital has been working for 3 years, in collaboration with the Strasbourg start-up InSimo, on the development of an LP simulator. This simulator is original because it allows the feeling by pressure of the passage of the various structures, and in particular the yellow ligament. This sensation is made possible by a haptic force feedback device.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group patient | Other | Other: performing lumbar punctures by students with standard trainingperforming lumbar punctures by students with standard training |
| experimental group patient | Experimental | Other: training students augmented reality simulatorperforming lumbar punctures by students with standard training and an augmented reality simulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Requiring a lumbar puncture as part of their routine care
- Male or female of legal age with no upper age limit
- French speaking
- Subject affiliated to a social health insurance scheme
- Not having expressed his or her opposition to the re-use of his or her data in the context of this research
Key exclusion criteria (7 listed)
- Previously undergone a lumbar puncture
- BMI > 35 kg/m².
- Spinal ankylosis: history of ankylosing spondylitis or Forestier's disease
- Impossible to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
- Subject under court protection
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 |
|---|---|---|
| performing lumbar punctures by students with standard trainingperformance of the puncture by the student have been previously trained with standard training | Other | control group patient |
| training students augmented reality simulatorperformance of the puncture by the student have been previously trained using the augmented reality simulator | Other | experimental group patient |
Primary outcome
Success rate of lumbar punctures in patients according to whether the students performing their first lumbar puncture were previously trained to perform this invasive procedure using the augmented reality simulator versus standard teaching.
Time frame: 3 days
Success rate of lumbar puncture as assessed by the collection of cerebrospinal fluid (CSF) at the end of the procedure. A successful LP is defined as the collection of CSF at the end of the procedure performed by the student without the assistance of a senior physician or resident and without interruption of the procedure by the patient.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Results publication: PubMed 40885925Felten R, Bigaut K, Wirth T, Kremer L, Gauer L, Arnold C, Ollivier I, Godet J, Scherlinger M, Dubois M, Sebbag E, De Seze J, Gottenberg JE. Advancing medical training with augmented reality and haptic feedback simulator: outcomes of a randomized controlled trial on lumbar puncture. BMC Med Educ. 2025 Aug 30;25(1):1231. doi: 10.1186/s12909-025-07536-6.
- Individual participant dataSharing planned: Undecided
Related trials for Lumbar Puncture
Not yet recruiting
The Effect of ShotBlocker on Symptoms of Pain, Anxiety, and Cortisol Hormone Levels
Pain, Anxiety
RecruitingObservational study
Thinking and Memory Problems in People With HIV
HIV Positive
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
Idiopathic Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus
Enrolling by invitation
Ultrasound-assisted vs Palpation-guided Lumbar Punctures
Lumbar Puncture
Not yet recruiting
Ultrasound Versus Palpation for Determining Spinal Puncture Level in Cesarean Section
Cesarean Section (MeSH: D002585), Anesthesia, Spinal (MeSH: D000775)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing performing lumbar punctures by students with standard training and training students augmented reality simulator in people with Lumbar Puncture, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 20 Jan 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Success rate of lumbar punctures in patients according to whether the students performing their first lumbar puncture were previously trained to perform this invasive procedure using the augmented reality simulator versus standard teaching. (time frame: 3 days). 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 NCT05269238, 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 20 Jan 2026.