Study of the Location of Motor Cortical Stimulation Elect... | NCT06216717

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

NCT06216717

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Recruiting

Last Update Posted

Jun 29, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Neuropathic Pain

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 13, 2023Actual

Primary Completion Date

Mar 16, 2025Actual

Completion Date

Jun 25, 2027Estimated

First Submitted Date

Jan 11, 2024

First Submission Date that Met QC Criteria

Jan 11, 2024

First Posted Date

Jan 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2026

Last Update Posted Date

Jun 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 to determine their relation to therapy response in chronic neuropathic refractory pain patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pourcentage of pain relief	percentage of pain relief for different stimulated areas	1 year

Secondary Outcomes

Measure	Description	Time Frame
location of leads on the postoperative imaging	location of leads on the postoperative imaging	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

adults
patient implanted with a motor cortical stimulation system for chronic neuropathic refractory pain,
patient with available postoperative scanner

Exclusion Criteria: None

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adults who were implanted with a motor cortical stimulation system for treatment of chronic neuropathic refractory pain between 2003-2023

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Petru ISAN	Contact	0642619135	+33	isan.p@chu-nice.fr
Cynthia CAILLON	Contact	0492034589	+33	caillon.c@chu-nice.fr

Overall Officials

Name	Affiliation	Role
Petru ISAN	Centre Hospitalier Universitaire de Nice	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU NICE	Recruiting	Nice	Alpes Maritimes		France

Condition Browse Module

MeSH Terms

ID	Term
D009437	Neuralgia

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided