Cranial Nerve PalsyCN TractoNCT02978911
Cranial Nerves Tractography
A study testing preoperative cerebral MRI and operative findings in people with Cranial Nerve Palsy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Introduction: The skull base tumors surgery remains a challenge since numerous cranial nerves or vessels closely surround them. Recently, diffusion tensor imaging has developed with the tractography following white fibers and visualizing functional tracts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cranial Nerve Palsy
- What is being tested?
- preoperative cerebral MRI and operative findings
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2016to 12 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who present a skull base tumor that requires surgical removal
- Patients adult, informed and agreed
Who cannot join
- Pregnant women
- Patients under 18 years old, unable to legally consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Neurologie B, Hôpital Neurologique, HCL
Bron, 69500
Timothée Jacquesson, MD, 472356921 ext. +33, timothee.jacquesson@neurochirurgie.fr
Timothée Jacquesson, MD
About this study
Official title: Diffusion Tensor Imaging and Tractography for Cranial Nerves. Interest in Skull Base Surgery and Anatomy
Introduction: The skull base tumors surgery remains a challenge since numerous cranial nerves or vessels closely surround them. Recently, diffusion tensor imaging has developed with the tractography following white fibers and visualizing functional tracts. Cranial nerves tractography could allow predicting their displacement by skull base tumors that may help the surgeon to spare them along the surgery.
Methods: Preoperative cerebral MRI was performed on patients who presented with skull base tumors. A 3 tesla MRI machine was used to acquire DTI sequence with specific parameters: 32 directions, slice thickness 2 mm, echo time 86 ms, repetition time 12000 ms, matrix 128x128, b-value 1000 s.mm-1. An anatomic sequence hyperT2 was overlaid as reference. Distortion was corrected by topup and eddy functions from FSL. Cranial nerves fibers were probabilistically tracked with Mrtrix3. Cranial nerves were selected according to their location around the tumor. The "radiological" expected position of the cranial nerve was compared to its "operative" real position.
- Conditions
- Cranial Nerve Palsy
- Being tested
- preoperative cerebral MRI and operative findings
- Keywords
- RMI
- Medical subject headings
- Cranial Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative cerebral MRI and operative findingsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Skull base tumors | Experimental | Patients who presented a skull base tumor that requires a surgical removal Receives: Procedure: preoperative cerebral MRI and operative findings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the expected and the real position of the selected cranial nerve
Selection of one or multiples cranial nerves of interest due to their close relationship with the tumor. Comparison of its/their position on MRI and during surgery.
Measured: Date of preoperative MRI (<3 months before the surgery)
Correlation between the expected and the real position of the selected cranial nerve
Selection of one or multiples cranial nerves of interest due to their close relationship with the tumor. Comparison of its/their position on MRI and during surgery.
Measured: at 3 months
Secondary outcomes (1)
postoperative cranial nerve palsy
comparison with preoperative status
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start12 Jul 2016
- Primary completion12 Jul 2026 (estimated)
- Study completion12 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cranial Nerve PalsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothée Jacquesson, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978911
- Sponsor's protocol ID
- 69HCL16_0759
- Other IDs
- 2015-A01113-46
- Acronym
- CN Tracto
- Status last verified
- Jan 2026
- First submitted
- 23 Nov 2016
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Tensor Imaging and Tractography for Cranial Nerves. Interest in Skull Base Surgery and Anatomy
- ClinicalTrials.gov ID
- NCT02978911
- Acronym / sponsor ID
- CN Tracto / 69HCL16_0759
- Conditions
- Cranial Nerve Palsy
- Keywords
- RMI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 12 Jul 2016 (actual)
- Primary completion
- 12 Jul 2026 (estimated)
- Study completion
- 12 Jul 2026 (estimated)
- First posted
- 1 Dec 2016 (estimated)
- 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.
Introduction: The skull base tumors surgery remains a challenge since numerous cranial nerves or vessels closely surround them. Recently, diffusion tensor imaging has developed with the tractography following white fibers and visualizing functional tracts. Cranial nerves tractography could allow predicting their displacement by skull base tumors that may help the surgeon to spare them along the surgery.
Methods: Preoperative cerebral MRI was performed on patients who presented with skull base tumors. A 3 tesla MRI machine was used to acquire DTI sequence with specific parameters: 32 directions, slice thickness 2 mm, echo time 86 ms, repetition time 12000 ms, matrix 128x128, b-value 1000 s.mm-1. An anatomic sequence hyperT2 was overlaid as reference. Distortion was corrected by topup and eddy functions from FSL. Cranial nerves fibers were probabilistically tracked with Mrtrix3. Cranial nerves were selected according to their location around the tumor. The "radiological" expected position of the cranial nerve was compared to its "operative" real position.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skull base tumors | Experimental | Procedure: preoperative cerebral MRI and operative findingsPatients who presented a skull base tumor that requires a surgical removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who present a skull base tumor that requires surgical removal
- Patients adult, informed and agreed
Key exclusion criteria (2 listed)
- Pregnant women
- Patients under 18 years old, unable to legally consent
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 |
|---|---|---|
| preoperative cerebral MRI and operative findings | Procedure or surgery | Skull base tumors |
Primary outcome
Correlation between the expected and the real position of the selected cranial nerve
Time frame: Date of preoperative MRI (<3 months before the surgery)
Selection of one or multiples cranial nerves of interest due to their close relationship with the tumor. Comparison of its/their position on MRI and during surgery.
Correlation between the expected and the real position of the selected cranial nerve
Time frame: at 3 months
Selection of one or multiples cranial nerves of interest due to their close relationship with the tumor. Comparison of its/their position on MRI and during surgery.
1 secondary outcome
postoperative cranial nerve palsy
Time frame: at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Timothée Jacquesson, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative cerebral MRI and operative findings in people with Cranial Nerve Palsy, run by Hospices Civils de Lyon 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothée Jacquesson, MD (472356921 ext. +33, timothee.jacquesson@neurochirurgie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the expected and the real position of the selected cranial nerve (time frame: Date of preoperative MRI (<3 months before the surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.