Follow-up of Post-spinal Implantable Neurostimulator PRECISION® (PRECISION)

November 5, 2019 updated by: Cemka-Eval

Two-years Follow-up of Post-spinal Implantable Neurostimulator PRECISION®

Assessing the long-term efficacy, complications, revision rates and final explantation of the device

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Longitudinal study with a follow-up of 2 years in patients implanted with the Precision neurostimulator.

This study will describe the characterisrics of the patients, of the implantation and will assess the long-term efficacy, complications, revision rates and final explantation of the device

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Multiple Locations, France
        • Hospitals implanting the neurostimulator Precision

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All implanted patients (primary implementation and reimplantation) with the neurostimulator PRECISION ®, during the inclusion period (1 year).

Description

Inclusion Criteria:

  • Adult patient receiving spinal implantation of a neurostimulator PRECISION ® ( primary implantation or reimplantation)

Exclusion Criteria:

  • Refusal of patient
  • Patient whose long-term monitoring will not be possible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neurostimulator Precision
Patients implanted or reimplanted with the neurostimulator Precision
Device: Neurostimulator Precision
All patients included must have been implanted with the neurostimulator Precision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 50% of the Overall Average Pain Over the Last 8 Days, Evaluated by Numerical Scale at the First Follow-up Visit, at 1 Year, and 2 Years.
Time Frame: From baseline until the end of the study at 24 months.
Percentage of patients (de novo implants) having a reduction of usual pain over the past 8 days of at least 50% at 12 and 24 months. The pain was measured with a numerical scale from 0 to 10 (0 = no pain and 10 = most intense pain). This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.
From baseline until the end of the study at 24 months.
Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years.
Time Frame: From baseline until the end of the study at 24 months.
The pain was evaluated with a numerical scale from 0 to 10. 0 = no pain and 10 = most intense pain. This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.
From baseline until the end of the study at 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale
Time Frame: From baseline until the end of the study at 24 months

Percentage of implanted patients (de novo implants) with an improvement of at least 30% at 12 and 24 months after inclusion for:

  • pain at the present time
  • usual pain over the past 8 days
  • the most severe pain in the last 8 days
From baseline until the end of the study at 24 months
Patients' Opinion on the Evolution of Pain
Time Frame: From baseline until the end of the study at 24 months
- Pain relief compared to what the patient with a de novo implant, felt before the implantation at 12 months and at 24 months.
From baseline until the end of the study at 24 months
Evolution of the Use of Other Pain Treatments
Time Frame: From baseline until the end of the study at 24 months
Rate of primary implanted patients who took at least one analgesic treatment at each follow-up (at 1 year and at 2 years)
From baseline until the end of the study at 24 months
Evolution of Quality of Life (SF-12) - Physical Score
Time Frame: From baseline until the end of the study at 24 months
Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) physical score at 12 and 24 months. An increase of this score indicates an improvement in physical "quality of life.
From baseline until the end of the study at 24 months
Patients' Willingness to Restart the Treatment
Time Frame: From baseline until the end of the study at 24 months
Patients' willingness to restart the treatment at 12 months and at 24 months.
From baseline until the end of the study at 24 months
Percentage of Patients With Anxiety and Depression Disorders
Time Frame: From baseline until the end of the study at 24 months
Evolution of the rate of patients with anxiety and depression disorders at12 and 24 months.
From baseline until the end of the study at 24 months
Evolution of Quality of Life (SF-12) - Mental Score
Time Frame: From baseline until the end of the study at 24 months
Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) mental score at 12 and 24 months. An increase of this score indicates an improvement in mental "quality of life.
From baseline until the end of the study at 24 months
Evolution of the Use of Level 3 Analgesics
Time Frame: From baseline until the end of the study at 24 months
Mean posology of level 3 analgesics at each follow-up (at 1 year and at 2 years). The posology was estimated in oral morphine equivalent dosage. At 1 year, 14 patients had a level 3 analgesic and at 2 years 18 patients had this type of analgesic. The posology was available for respectively 4 and 16 patients
From baseline until the end of the study at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cemka-Eval

Collaborators

Boston Scientific Corporation

Investigators

  • Study Director: Elisabeth Dr Mouton, MD, Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

August 1, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Actual)

November 6, 2019

Last Update Submitted That Met QC Criteria

November 5, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011045
  • 913018 (Other Identifier: CNIL)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared; Only aggregated data will be communicated

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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