Spinal Cord Stimulation (SCS) Dosing Study

Status: Completed
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This study characterized the effects of amplitude on subject satisfaction and pain relief in subjects being treated by SCS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: No
View:

• 22 years of age or older

• Implanted with a RestoreSensor system (for back and leg pain) for at least 1 month

• Has approproate SCS settings

• Willing and able to provide signed and dated informed consent

• Capable of comprehending and consenting in English

• Capable of getting into the supine and sitting positions

• Willing and able to comply with all study procedures and visits

• On stable (no change in dose, route, or frequency) prescribed pain medications

Locations
United States
Arizona
Arizona Pain Doctors
Chandler
Georgia
Georgia Pain and Wellness Center
Lawrenceville
Indiana
Global Scientific Innovations
Evansville
Goodman Campbell Brain and Spine
Indianapolis
Kentucky
Kentuckiana Pain Specialists
Louisville
Drez One, LLC
Somerset
Missouri
Regional Brain & Spine
Cape Girardeau
Texas
Precision Spine Care
Tyler
Washington
Northwest Pain Care, Inc.
Spokane
Wisconsin
University of Wisconsin
Madison
Time Frame
Start Date: November 1, 2017
Completion Date: March 15, 2019
Participants
Target number of participants: 30
Treatments
Experimental: Spinal Cord Stimulation
Each subject was programmed to 4 different amplitude settings: 80%, 60%, 40% and 20% of perception threshold amplitude
Authors
Neil Thakkar, Amit Patel, Mathew Jose, Todd Schmidt, Ajith Nair, Lauren Woodward, Tristan Pico, Yuri Khibkin, Nathan Rudin, Tyler Ptacek, Ryan McKenna, Aaron Calodney, Mahendra Sanapati, Christopher Reis, Alaa Abd-Elsayed, Amr O El-Naggar, John Hatheway
Sponsors
Leads: MedtronicNeuro

This content was sourced from clinicaltrials.gov

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