Recruitment

Recruitment Status
Recruiting

Inclusion Criteria

Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use
Signed a valid, IRB/EC-approved informed consent form
18 years of age or older
Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use
Signed a valid, IRB/EC-approved informed consent form
18 years of age or older

Exclusion Criteria

Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
Contraindicated for Boston Scientific neurostimulation system
Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
Contraindicated for Boston Scientific neurostimulation system

Summary

Conditions
Pain
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The study is a prospective, multi-center, global registry of Boston Scientific neurostimulation systems for pain. The study treatment will consist of neurostimulation trial therapy with any commercially approved Boston Scientific Corporation neurostimulator for pain. Positive trials, subjects with a...

The study is a prospective, multi-center, global registry of Boston Scientific neurostimulation systems for pain. The study treatment will consist of neurostimulation trial therapy with any commercially approved Boston Scientific Corporation neurostimulator for pain. Positive trials, subjects with a successful trial outcome, may progress to permanent implant of a neurostimulation system. Individualization of neurostimulation therapy for pain will be determined according to investigator discretion and site routine care, and in accordance with inclusion and exclusion criteria.

Inclusion Criteria

Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use
Signed a valid, IRB/EC-approved informed consent form
18 years of age or older
Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use
Signed a valid, IRB/EC-approved informed consent form
18 years of age or older

Exclusion Criteria

Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
Contraindicated for Boston Scientific neurostimulation system
Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
Contraindicated for Boston Scientific neurostimulation system

Tracking Information

NCT #
NCT01719055
Collaborators
Not Provided
Investigators
Study Director: Roshini Jain Boston Scientific Corporation