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RestoreSensor Study

CompletedNot applicableNCT01106404
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The purpose of the study is to gather clinical information on subjects' experiences with and without the use of the new feature of the RestoreSensor implantable neurostimulator (INS).

Study details

Official title
RestoreSensor Study
Conditions
Interventions
  • Device: RestoreSensor Neurostimulation System
Sponsor
MedtronicNeuro
Start date
2010-04
Primary completion
2011-01
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
10

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Meets the indications as an appropriate surgical candidate (after successful SCS screening trial) for implant of a neurostimulation system for spinal cord stimulation (SCS) treatment of trunk and/or limb pain, per labeled indications * 18 years of age or older * Willing and able to attend visits and comply with the study protocol * Capable of using the patient programmer and recharging the neurostimulator (INS), able to read and answer questionnaires in English, without assistance of a caregiver * Males and non-pregnant females Exclusion Criteria: * Has had a prior implantable SCS neurostimulation system * Currently enrolled, or plans to enroll in another investigational device or drug trial during the study * Has unresolved legal issues related to their pain condition for which they would be receiving neurostimulation * Requires cervical placement of leads.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01106404