Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial

Boston Scientific

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Programming

Study type: Interventional

Funder types: Industry

Identifiers

NCT02988713

91153461

Details and patient eligibility

About

This is a prospective, multi-center, non-randomized, exploratory, single-arm study characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Study candidate is undergoing a spinal cord stimulation (SCS) trial of BSC neurostimulation system, per local directions for use (DFU).
• Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
• Subject is 18 years of age or older when written informed consent is obtained.

Key Exclusion Criteria:

• Subject meets any contraindication in BSC neurostimulation system local directions for use (DFU).

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Spinal cord stimulation

Experimental group

Description:

Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial

Treatment:

Device: Programming