Clinical trial NCT01106404: RestoreSensor Study
Official title: RestoreSensor Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2010-04-19
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Subjects With Improved Pain Relief and/or Convenience During the AdaptiveStim Programming Arm Relative to the Manual Programming Arm
timeFrame: 16 weeks post-implant
Secondary outcomes:
measure: Percentage of Subjects With Worsened Pain Relief When Using AdaptiveStim Compared to Manual Programming
timeFrame: 16 weeks post-implant
measure: Manual Adjustments Presented as Button Presses
timeFrame: Baseline, 10 weeks and 16 weeks post-implant
measure: NPRS Scores From Baseline to Follow-up Visits at 10 Weeks and 16 Weeks Post-implant
timeFrame: Baseline, 10 weeks and 16 weeks post-implant
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Oceanside
country: United States
state: California
city: Edina
country: United States
state: Minnesota
city: Las Vegas
country: United States
state: Nevada
city: Voorhees
country: United States
state: New Jersey
city: Eugene
country: United States
state: Oregon
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
References:
citation: 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.