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Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy (SME)

This study is currently recruiting participants.
Verified January 2013 by Medtronic Bakken Research Center
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01778426
First received: January 24, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over 2 years following SCS implant.

This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for SCS in approved indication in France.


Condition
Chronic Pain Syndrome

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • PainStim Efficacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate the percentage of patients with 50% decrease in the VAS (Visual Analogic Scale) score over 2 years following SCS implant in first implant patients


Secondary Outcome Measures:
  • Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Report all adverse device effects and procedure related adverse events over 2 years following SCS implant.


Estimated Enrollment: 400
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Medtronic neurostimulator
Patients suffering from chronic neuropathic pain syndrome implanted (first implant or replacements) with a Medtronic neurostimulator.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients implanted (first implant or replacements) with a Medtronic neurostimulator in selected French sites .

Criteria

Inclusion Criteria:

  • Patient indicated for Spinal Cord Stimulation (pain therapy)
  • Patient implanted for less than 3 months or hospitalized for the implant of a Medtronic neurostimulator including:
  • primary implant with Spinal Cord Stimulation indication and positive test of stimulation or
  • device replacement of a Medtronic neurostimulator used for Pain Therapy
  • Evaluation of usual pain in the back, upper and lower limbs using a visual analogic scale must be available for the 3 days preceding implant.
  • Treatments must also be available
  • Patient read and signed the data release form

Exclusion Criteria:

  • Patient declined participation
  • Patient is not available for follow up
  • Stimulation of other body part than spinal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778426

Contacts
Contact: Julie Ruiz +33155381788 julie.ruiz@medtronic.com
Contact: Frédérique Debroucker +33155381787 frederique.debroucker@medtronic.com

Locations
France
Hôpital Saint Anne - 1 rue Cabanis Recruiting
Paris, France, 75014
Contact: Marie-Christine DJIAN, Doctor     +33145658641     mc.djian@ch-sainte-anne.fr    
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
Study Chair: Marie-Christine DJIAN, MD Hôpital Saint Anne Paris
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01778426     History of Changes
Other Study ID Numbers: 1051
Study First Received: January 24, 2013
Last Updated: January 24, 2013
Health Authority: France: The Commission nationale de l’informatique et des libertés
France: Haute Autorité de Santé Transparency Commission
France: Conseil National de l'Ordre des Médecins

Keywords provided by Medtronic Bakken Research Center:
Chronic neuropathic pain syndrome
Spinal Cord Stimulation
Painstim devices
Efficacy
Safety

Additional relevant MeSH terms:
Somatoform Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013