RestoreSensor Study

Medtronic

Status

Completed

Conditions

Chronic Pain

Treatments

Device: RestoreSensor Neurostimulation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01106404

1651

Details and patient eligibility

About

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).

Full 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.

Enrollment

79 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.