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

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

January 11, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

January 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

January 11, 2024

Last Update Submit

January 22, 2024

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

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

January 20, 2024

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

January 23, 2024

Record last verified: 2024-01