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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01778426
First received: January 24, 2013
Last updated: March 10, 2014
Last verified: March 2014

January 24, 2013
March 10, 2014
January 2012
January 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01778426 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy
Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy

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.

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
2 Years
Not Provided
Non-Probability Sample

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

Chronic Pain Syndrome
Not Provided
Patients with Medtronic neurostimulator
Patients suffering from chronic neuropathic pain syndrome implanted (first implant or replacements) with a Medtronic neurostimulator.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
418
January 2016
January 2016   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01778426
1051
No
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Medtronic
Study Chair: Marie-Christine DJIAN, MD Hôpital Saint Anne Paris
Medtronic Bakken Research Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP