RestoreSensor Study
1 other identifier
interventional
79
1 country
10
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable chronic-pain
Started Apr 2010
Shorter than P25 for not_applicable chronic-pain
10 active sites
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
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 2, 2010
CompletedFirst Posted
Study publicly available on registry
April 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
August 1, 2012
CompletedAugust 30, 2012
August 1, 2012
9 months
April 2, 2010
January 12, 2012
August 17, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects With Improved Pain Relief and/or Convenience During the AdaptiveStim Programming Arm Relative to the Manual Programming Arm
After subjects experienced both AdaptiveStim and manual programming at 16 weeks post-implant, subjects were asked to compare pain relief and convenience when they had AdaptiveStim ON to AdaptiveStim OFF in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no loss of convenience or improved convenience with no loss of pain relief during the AdaptiveStim programming arm relative to the manual programming arm. These subjects were considered successful for the primary objective.
16 weeks post-implant
Secondary Outcomes (3)
Percentage of Subjects With Worsened Pain Relief When Using AdaptiveStim Compared to Manual Programming
16 weeks post-implant
Manual Adjustments Presented as Button Presses
Baseline, 10 weeks and 16 weeks post-implant
NPRS Scores From Baseline to Follow-up Visits at 10 Weeks and 16 Weeks Post-implant
Baseline, 10 weeks and 16 weeks post-implant
Study Arms (2)
6-week AdaptiveStim followed by 6-week manual programming
OTHER6-week manual followed by 6-week AdaptiveStim programming
OTHERInterventions
Adjustments to stimulation settings are automatic when the AdaptiveStim feature of the device is turned "ON" and manual when the AdaptiveStim feature of the device is turned "OFF".
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedtronicNeurolead
Study Sites (10)
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
Edina, Minnesota, 55435, United States
Unknown Facility
Las Vegas, Nevada, 89149, United States
Unknown Facility
Voorhees Township, New Jersey, 08043, United States
Unknown Facility
Eugene, Oregon, 97401, United States
Unknown Facility
Dallas, Texas, 75237, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
San Antonio, Texas, 78258, United States
Unknown Facility
Salt Lake City, Utah, 84106, United States
Related Publications (1)
Schultz DM, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven position-adaptive spinal cord stimulation for chronic pain. Pain Physician. 2012 Jan-Feb;15(1):1-12.
PMID: 22270733DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Sun, Senior Clinical Research Manager
- Organization
- Neuromodulation Emerging Therapy Clinical Research, Medtronic, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2010
First Posted
April 19, 2010
Study Start
April 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
August 30, 2012
Results First Posted
August 1, 2012
Record last verified: 2012-08