BurstDR™ micrOdosing stimuLation in De-novo Patients

NCT03350256 | Completed Results FDA Device

• 1 other identifier: SJM-CIP-10215
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Pain, Intractable; Pain, Back

Outcome Measures

Primary Outcomes (4)

• Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation

  Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

  baseline and 1 week after trial lead implant (trial stimulation)

• Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1

  Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

  Baseline and 1 month follow up visit

• Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2

  Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

  Baseline and 3 month follow up visit

• Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3

  Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

  Baseline and 6 month follow up visit

Secondary Outcomes (12)

• Change in Quality of Life Between Baseline and Trial Stimulation

  Baseline and 1 week after trial lead implant (trial stimulation)

• Change in Quality of Life Between Baseline and Follow up 1

  Baseline and 1 month follow up visit

• Change in Quality of Life Between Baseline and Follow up 2

  Baseline and 3 month follow up visit

• Change in Quality of Life Between Baseline and Follow up 3

  Baseline and 6 month follow up visit

• Change in Disability Index Between Baseline and Trial Stimulation

  Baseline and 1 week after trial lead implant (trial stimulation)

Other Outcomes (1)

• Stimulation ON/OFF Ratio

  6 month follow up visit

Study Arms (1)

Microdosing group

EXPERIMENTAL

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

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

Interventions

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

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

Microdosing group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (5)

Thrive Clinic

Santa Rosa, California, 95403, United States

Location

Nevada advanced pain specialists

Reno, Nevada, 89511, United States

Location

OnSite Clinical Solutions

Asheville, North Carolina, 28803, United States

Location

Ambulatory Surgery Center of Killeen

Killeen, Texas, 76542, United States

Location

Premier Pain Solutions

Charleston, West Virginia, 25301, United States

Location

MeSH Terms

Conditions

Pain, Intractable; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Filippo Agnesi
• Organization: Abbott

filippo.agnesi@abbott.com

+19725264860

Study Officials

• Timothy R Deer, MD

  The Center for Pain Relief

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: November 10, 2017
• First Posted: November 22, 2017
• Study Start: October 30, 2017
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2019
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)