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

NCT04909593 | Completed Results FDA Device

• 1 other identifier: A4091
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Pain; Intractable Pain; Low Back Pain; Pain, Neuropathic; Pain, Back

Outcome Measures

Primary Outcomes (1)

• Perception Threshold

  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

  Programming Visit (up to 15 days post-screening)

Study Arms (1)

Spinal Cord Stimulation

EXPERIMENTAL

SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.

Device: Spinal Cord Stimulation

Interventions

Spinal Cord Stimulation DEVICE

Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters

Also known as: neurostimulation

Spinal Cord Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, 29601, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain, Intractable; Low Back Pain; Neuralgia; Back Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Sr. Director, Clinical Operations
• Organization: Boston Scientific Corporation

BSNClinicalTrials@bsci.com

855-213-9890

Study Officials

• Natalie Bloom Lyons

  Boston Scientific Neuromodulation Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 2, 2021
• Study Start: May 24, 2021
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-12

Locations

US (1)