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
  Purpose

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 Intervention
Chronic Pain
Device: RestoreSensor Neurostimulation System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RestoreSensor Study

Resource links provided by NLM:


Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 79
Study Start Date: April 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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".

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106404

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, 78258
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
MedtronicNeuro
  More Information

No publications provided by MedtronicNeuro

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01106404     History of Changes
Other Study ID Numbers: 1651
Study First Received: April 2, 2010
Results First Received: January 12, 2012
Last Updated: August 17, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 29, 2014