NCT03189823

Brief Summary

In order to create insights in the effects of Motor cortex stimulation (MCS) on intractable pain, an open observational study was started in 2003. The aim of this research is to:

  1. 1.to determine the clinical effectivity of MCS on pain intensity after 1 month, 1 year and 3 years of stimulation
  2. 2.to determine the clinical effectivity of MCS on QoL and daity medication intake after 3 years of MCS

Trial Health

100
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Status
completed

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

January 1, 2003

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

14 years

First QC Date

June 7, 2017

Last Update Submit

June 15, 2017

Conditions

Pain, IntractableCentral Pain SyndromeFacial Pain

Outcome Measures

Primary Outcomes (1)

  • Changes in pain intensity

    According to VAS scores

    1month, 6months, 1 year and 3 years postoperative

Secondary Outcomes (2)

  • Changes in quality of life

    3 years postoperative

  • Changes in daily medication intake

    3 years postoperative

Other Outcomes (1)

  • Occurence of complications

    during 3 years postoperative

Interventions

Specify, model 3998, Medtronic Inc., Minneapolis, MN, USADEVICE

In MCS, an electrode is placed perpendicular to the central sulcus in the epidural space (Specify, model 3998, Medtronic Inc., Minneapolis, MN, USA) in order to obtain pain relief.

Also known as: Motor cortex stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Dutch patients that suffered from chronic, intractable neuropathic pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Pain, IntractableFacial Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

June 7, 2017

First Posted

June 16, 2017

Study Start

January 1, 2003

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

June 16, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

An anominized excel file, compatible with SPSS will be attached to the submitted manuscript