RestoreSensor Study

• ClinicalTrials.gov Identifier: NCT01106404
• Recruitment Status: Completed
• First Posted: April 19, 2010
• Results First Posted: August 1, 2012
• Last Update Posted: August 30, 2012
• Sponsor: MedtronicNeuro
• Information provided by (Responsible Party): MedtronicNeuro

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Device: RestoreSensor Neurostimulation System	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: RestoreSensor Study
• Study Start Date: April 2010
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: January 2011

Arms and Interventions

Arm	Intervention/treatment
6-week AdaptiveStim followed by 6-week manual programming	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".
6-week manual followed by 6-week AdaptiveStim programming	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".

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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.

Secondary Outcome Measures :

1. Percentage of Subjects With Worsened Pain Relief When Using AdaptiveStim Compared to Manual Programming [ Time Frame: 16 weeks post-implant ]
   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".
2. Manual Adjustments Presented as Button Presses [ Time Frame: Baseline, 10 weeks and 16 weeks post-implant ]
   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.
3. 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 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Alabama

Huntsville, Alabama, United States, 35801

United States, California

Oceanside, California, United States, 92056

United States, Minnesota

Edina, Minnesota, United States, 55435

United States, Nevada

Las Vegas, Nevada, United States, 89149

United States, New Jersey

Voorhees, New Jersey, United States, 08043

United States, Oregon

Eugene, Oregon, United States, 97401

United States, Texas

Dallas, Texas, United States, 75237

San Antonio, Texas, United States, 78229

San Antonio, Texas, United States, 78258

United States, Utah

Salt Lake City, Utah, United States, 84106

Sponsors and Collaborators

MedtronicNeuro

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: MedtronicNeuro
• ClinicalTrials.gov Identifier: NCT01106404
• Other Study ID Numbers: 1651
• First Posted: April 19, 2010
• Results First Posted: August 1, 2012
• Last Update Posted: August 30, 2012
• Last Verified: August 2012

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations