NCT06216717

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Nov 2023Jun 2027

Study Start

First participant enrolled

November 13, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2025

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2027

Expected
Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

January 11, 2024

Last Update Submit

June 25, 2026

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • Pourcentage of pain relief

    percentage of pain relief for different stimulated areas

    1 year

Secondary Outcomes (1)

  • location of leads on the postoperative imaging

    1 month

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU NICE

Nice, Alpes Maritimes, France

RECRUITING

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Petru ISAN

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Petru ISAN

CONTACT

0642619135isan.p@chu-nice.fr

Cynthia CAILLON

CONTACT

0492034589caillon.c@chu-nice.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2024

First Posted

January 22, 2024

Study Start

November 13, 2023

Primary Completion

March 16, 2025

Study Completion (Estimated)

June 25, 2027

Last Updated

June 29, 2026

Record last verified: 2026-06

Locations

FR(1)