Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial

Not Applicable

Completed

• Conditions: Pain, Back; Pain, Neuropathic; Chronic Pain; Intractable Pain; Low Back Pain
• Interventions: Device: Spinal Cord Stimulation

• Registration Number: NCT04909593
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

The purpose of the study is to assess the feasibility of using information extracted from physiologic signals to automatically adjust stimulation in patients undergoing Spinal Cord Stimulation (SCS).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-21
• Study Start: 2021-05-24
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-06-02
• Primary Completion: 2022-11-22
• Study Completion: 2022-11-22
• Results First Submitted: 2024-10-01
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Results First Posted: 2024-12-06
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Study candidate is undergoing a temporary SCS trial of commercially approved BSC neurostimulator system, per local directions for use (DFU).
• Subject signed a valid, EC/IRB-approved informed consent form.
• Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law when written informed consent is obtained.
• In the clinician best judgment, subject is able to distinguishably describe quality and location of sensation and pain.

Key

Exclusion Criteria

• Subject meets any contraindication in BSC neurostimulation system local DFU.
• Investigator-suspected gross lead migration during the SCS trial period which may preclude the study candidate from receiving adequate SCS therapy.
• Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that in the clinician's best judgement would limit study candidate's ability to assess and report sensation information.
• Subject is currently diagnosed with a physical impairment, or exhibits a condition that would limit study candidate's ability to complete study assessments.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal Cord Stimulation	Spinal Cord Stimulation	SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.

Primary Outcome Measures

Name	Time	Method
Perception Threshold	Programming Visit (up to 15 days post-screening)	Percent change in patient's perceiving spinal cord stimulation (i.e. Perception Threshold) when going from a reclining to sitting position in a reclining chair

Trial Locations

Locations (1)

PCPMG Clinical Research Unit, LLC; 🇺🇸 Greenville, South Carolina, United States