Neuropathic PainNCT06216717
Study of the Location of Motor Cortical Stimulation Electrodes in Chronic Neuropathic Refractory Patients
An observational study of Neuropathic Pain, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Cortical stimulation has been used since 1991 to treat neuropathic pain. However, the underlying mechanisms are still incompletely understood and under-studied. In this protocol, the investigators aim to study the myeloarchitectonic and functional characteristics of areas activated by cortical epidural electrodes and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2023to 25 Jun 2027
- Phase
- Observational
- 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
- Adult, Older adult
Study population: adults who were implanted with a motor cortical stimulation system for treatment of chronic neuropathic refractory pain between 2003-2023
Who may be able to join
- adults
- patient implanted with a motor cortical stimulation system for chronic neuropathic refractory pain,
- patient with available postoperative scanner
Who cannot join
None listed.
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
CHU NICE
Nice, Alpes Maritimes
petru isan, 064219135 ext. + 33, isan.p@chu-nice.fr
cynthia caillon, 0492034589 ext. +33, caillon.@chu-nice.fr
About this study
Cortical stimulation has been used since 1991 to treat neuropathic pain. However, the underlying mechanisms are still incompletely understood and under-studied. In this protocol, the investigators aim to study the myeloarchitectonic and functional characteristics of areas activated by cortical epidural electrodes and to determine their relation to therapy response in chronic neuropathic refractory pain patients.
- Conditions
- Neuropathic Pain
- Medical subject headings
- Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Pourcentage of pain relief
percentage of pain relief for different stimulated areas
Measured: 1 year
Secondary outcomes (1)
location of leads on the postoperative imaging
location of leads on the postoperative imaging
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start13 Nov 2023
- Primary completion16 Mar 2025
- Study completion25 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petru ISAN, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216717
- Sponsor's protocol ID
- 24Neurochir01
- Status last verified
- Jun 2026
- First submitted
- 11 Jan 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Location of Motor Cortical Stimulation Electrodes in Chronic Neuropathic Refractory Patients
- ClinicalTrials.gov ID
- NCT06216717
- Acronym / sponsor ID
- 24Neurochir01
- Conditions
- Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 16 Mar 2025 (actual)
- Study completion
- 25 Jun 2027 (estimated)
- First posted
- 22 Jan 2024 (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.
Cortical stimulation has been used since 1991 to treat neuropathic pain. However, the underlying mechanisms are still incompletely understood and under-studied. In this protocol, the investigators aim to study the myeloarchitectonic and functional characteristics of areas activated by cortical epidural electrodes and to determine their relation to therapy response in chronic neuropathic refractory pain patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adults who were implanted with a motor cortical stimulation system for treatment of chronic neuropathic refractory pain between 2003-2023
Key inclusion criteria (3 listed)
- adults
- patient implanted with a motor cortical stimulation system for chronic neuropathic refractory pain,
- patient with available postoperative scanner
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pourcentage of pain relief
Time frame: 1 year
percentage of pain relief for different stimulated areas
1 secondary outcome
location of leads on the postoperative imaging
Time frame: 1 month
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 29 Jun 2026.
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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.
Petru ISAN principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by Centre Hospitalier Universitaire de Nice 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 3 inclusion and 0 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 29 Jun 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 Petru ISAN (0642619135 ext. +33, isan.p@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pourcentage of pain relief (time frame: 1 year). 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 29 Jun 2026.