NCT03259451

Brief Summary

A retrospective, monocentric, observational, descriptive, open study of a cohort of 149 patients from January 2014 to December 2015

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

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 Start

First participant enrolled

September 26, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

1.3 years

First QC Date

August 21, 2017

Last Update Submit

April 11, 2018

Conditions

Chronic Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

  • Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term

    Improvement of pain symptoms by at least 30% on the numerical scale

    Day 7

  • Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term (≤ 1 month)

    Improvement of pain symptoms by at least 30% on the numerical scale

    Month 1

Secondary Outcomes (1)

  • Evaluate the effectiveness of rTMS in the treatment of long-term chronic neuropathic pain (> 6 months)

    Month 6

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)DEVICE

Eligibility Criteria

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

Patient with chronic neuropathic pain

You may qualify if:

  • \- patient older than 18 years old with chronic neuropathic pain who are resistant to drug therapy for which treatment with rTMS is indicated between January 2014 and December 2015

You may not qualify if:

  • Patient less than 18 years old
  • Pregnant woman
  • Non-neuropathic pain
  • Pain \<6 months
  • Unbalanced epilepsy
  • Patient with a contraindication for cerebral MRI (cochlear implant, ocular metallic foreign bodies, patient with a pacemaker, mechanical valve)
  • Psychiatric pathology
  • Person subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics
0

Study Design

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

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 23, 2017

Study Start

September 26, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

April 12, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)