BurstDR™ micrOdosing stimuLation in De-novo Patients

NCT ID: NCT03350256

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-30
• Study Completion Date: 2019-07-02

Brief Summary

The purpose of this study is to evaluate the therapeutic efficacy of microdosing BurstDR stimulation in spinal cord stimulation (SCS) patients with chronic intractable back and/or leg pain.

Detailed Description

Microdosing BurstDR consists of periods during which stimulation is delivered with standard BurstDR stimulation parameters alternated with periods during which no stimulation is being delivered.

In this study the investigators propose to evaluate therapeutic efficacy of BurstDR microdosing, and determine optimal microdosing programming parameters in chronic pain patients, who are eligible for SCS therapy.

Conditions

Pain, Intractable; Pain, Back

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Microdosing group

Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.

Group Type: EXPERIMENTAL

Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.

Intervention Type: DEVICE

BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.

Interventions

Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.

BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject is able to provide informed consent to participate in the study;
• Subject diagnosed with chronic intractable pain associated with back and/or limbs;
• Subject is 18 years of age or older;
• Subject has failed to respond to at least 6 months of conventional treatment which may include pharmacological treatment, physical therapy, epidural injections;
• Subject has a back and/or leg pain intensity of at least 6.0 cm out of 10.0 cm on the average back and/or leg pain visual analogue scale at baseline;
• Subject's medical record has been evaluated by the Investigator to ensure that the subject is a good candidate for a neurostimulation system;
• Subject is on stable pain medications with a total opioid for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose increase until the 3 month visit;
• Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;
• Female candidates of child-bearing potential agree to commit to the use of an effective method of contraception (including but not limited to sterilization, barrier devices, oral contraceptives, intrauterine devices (IUDs), condoms, rhythm method, or abstinence) for the duration of the study

Exclusion Criteria

Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia or uncontrolled diabetes mellitus;

• Subject is currently participating in a clinical investigation that includes an active treatment arm;
• Subject has been implanted with or participated in a trial period for a neurostimulation system;
• Subject has an infusion pump;
• Subject has evidence of an active disruptive psychological or psychiatric disorder as determined as per standard of care;
• Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator;
• Subject is immunocompromised;
• Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor);
• Subject has history of cancer requiring active treatment in the last 12 months;
• Subject has an existing medical condition that is likely to require the use of diathermy in the future;
• Subject has documented history of allergic response to titanium or silicone;
• Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection;
• Subject is a female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test);
• Subject has life expectancy of less than 6 months;
• Subject is involved in an injury claim under current litigation

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy R Deer, MD

Role: PRINCIPAL_INVESTIGATOR

The Center for Pain Relief

Locations

Thrive Clinic

Santa Rosa, California, United States

Nevada advanced pain specialists

Reno, Nevada, United States

OnSite Clinical Solutions

Asheville, North Carolina, United States

Ambulatory Surgery Center of Killeen

Killeen, Texas, United States

Premier Pain Solutions

Charleston, West Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SJM-CIP-10215

Identifier Type: -

Identifier Source: org_study_id