- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06216717
Study of the Location of Motor Cortical Stimulation Electrodes in Chronic Neuropathic Refractory Patients
June 25, 2026 updated by: Centre Hospitalier Universitaire de Nice
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 Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Petru ISAN
- Phone Number: +33 0642619135
- Email: isan.p@chu-nice.fr
Study Contact Backup
- Name: Cynthia CAILLON
- Phone Number: +33 0492034589
- Email: caillon.c@chu-nice.fr
Study Locations
-
-
Alpes Maritimes
-
Nice, Alpes Maritimes, France
- Recruiting
- CHU NICE
-
Contact:
- petru isan
- Phone Number: + 33 064219135
- Email: isan.p@chu-nice.fr
-
Contact:
- cynthia caillon
- Phone Number: +33 0492034589
- Email: caillon.@chu-nice.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
adults who were implanted with a motor cortical stimulation system for treatment of chronic neuropathic refractory pain between 2003-2023
Description
Inclusion Criteria
- adults
- patient implanted with a motor cortical stimulation system for chronic neuropathic refractory pain,
- patient with available postoperative scanner
Exclusion Criteria: None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pourcentage of pain relief
Time Frame: 1 year
|
percentage of pain relief for different stimulated areas
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
location of leads on the postoperative imaging
Time Frame: 1 month
|
location of leads on the postoperative imaging
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Petru ISAN, Centre Hospitalier Universitaire De Nice
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 13, 2023
Primary Completion (Actual)
March 16, 2025
Study Completion (Estimated)
June 25, 2027
Study Registration Dates
First Submitted
January 11, 2024
First Submitted That Met QC Criteria
January 11, 2024
First Posted (Actual)
January 22, 2024
Study Record Updates
Last Update Posted (Actual)
June 29, 2026
Last Update Submitted That Met QC Criteria
June 25, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24Neurochir01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.