Study of the Location of Motor Cortical Stimulation Electrodes in Chronic Neuropathic Refractory Patients

January 22, 2024 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

Not yet 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

Study Contact Backup

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.

Sponsor

Centre Hospitalier Universitaire de Nice

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 (Estimated)

January 20, 2024

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2024

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 (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

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.

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