RestoreSensor Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

MedtronicNeuro

ClinicalTrials.gov Identifier:

NCT01106404

First received: April 2, 2010

Last updated: August 17, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 2, 2010
Last Updated Date	August 17, 2012
Start Date ^ICMJE	April 2010
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 25, 2012)	Percentage of Subjects With Improved Pain Relief and/or Convenience During the AdaptiveStim Programming Arm Relative to the Manual Programming Arm [ Time Frame: 16 weeks post-implant ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01106404 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 25, 2012)	Percentage of Subjects With Worsened Pain Relief When Using AdaptiveStim Compared to Manual Programming [ Time Frame: 16 weeks post-implant ] [ Designated as safety issue: No ] The pain relief question was a 5-point Likert scale question comparing pain relief when using AdaptiveStim programming relative to manual programming after subjects finished both programming periods. The choices were much worse pain relief with AdaptiveStim, somewhat worse pain relief with AdaptiveStim, no difference in pain relief, somewhat better pain relief with AdaptiveStim, and much better pain relief with AdaptiveStim. Subjects who had worsening pain relief were defined as subjects who responded "much worse pain relief with AdaptiveStim" or "somewhat worse pain relief with AdaptiveStim". Manual Adjustments Presented as Button Presses [ Time Frame: Baseline, 10 weeks and 16 weeks post-implant ] [ Designated as safety issue: No ] The number of individual adjustments, ie, button presses, were recorded automatically in the patient programmer, which was specifically designed for this study. The number of button presses per day for manual patient programmer adjustments during the manual programming arm and the AdaptiveStim programming arm of the study were compared. NPRS Scores From Baseline to Follow-up Visits at 10 Weeks and 16 Weeks Post-implant [ Time Frame: Baseline, 10 weeks and 16 weeks post-implant ] [ Designated as safety issue: No ] The 11-point (ie, 0-10) numeric rating scale of pain intensity (NPRS) was used to assess the overall pain at baseline and follow-up visits. In the pain diary, subjects were presented a numeric scale with numbers from 0 to 10, with 0 meaning "No pain" and 10 meaning "Pain as bad as you can imagine," accompanied by the instructions "Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours." The subjects were asked to complete a diary for 7 consecutive days before implant, 10 weeks, and 16 weeks post-implant visits.
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	RestoreSensor Study
Official Title ^ICMJE	RestoreSensor Study
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).
Detailed Description	This study is a multi-center, prospective, open-label, randomized, crossover study that is designed to gather clinical information on subjects' experiences with the use of the new feature of the RestoreSensor implantable neurostimulator. Current spinal cord stimulators for chronic intractable pain stimulate targeted nerves along the spine using electrical impulses. The stimulation interferes with the transmission of pain signals to the brain replacing painful sensations with a tingling sensation called paresthesia. Variation in the intensity of neurostimulation with body position is a challenge for some patients implanted with conventional spinal cord stimulation systems because positional changes may result in overstimulation or understimulation. Patients need to manually adjust their stimulation using the patient programmer to maintain their comfort level during position changes. The AdaptiveStim feature of the RestoreSensor neurostimulator was developed to address this challenge by improving pain relief and/or convenience relative to manual programming adjustments.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Chronic Pain
Intervention ^ICMJE	Device: RestoreSensor Neurostimulation System 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".
Study Arm (s)	6-week AdaptiveStim followed by 6-week manual programming Intervention: Device: RestoreSensor Neurostimulation System 6-week manual followed by 6-week AdaptiveStim programming Intervention: Device: RestoreSensor Neurostimulation System
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	79
Completion Date	January 2011
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01106404
Other Study ID Numbers ^ICMJE	1651
Has Data Monitoring Committee	No
Responsible Party	MedtronicNeuro
Study Sponsor ^ICMJE	MedtronicNeuro
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	MedtronicNeuro
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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