Clinical trial NCT03350256: BurstDR™ micrOdosing stimuLation in De-novo Patients
Official title: BurstDR™ micrOdosing stimuLation in De-novo Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Intractable
Pain, Back
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2017-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation
timeFrame: baseline and 1 week after trial lead implant (trial stimulation)
measure: Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1
timeFrame: Baseline and 1 month follow up visit
measure: Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2
timeFrame: Baseline and 3 month follow up visit
measure: Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3
timeFrame: Baseline and 6 month follow up visit
Secondary outcomes:
measure: Change in Quality of Life Between Baseline and Trial Stimulation
timeFrame: Baseline and 1 week after trial lead implant (trial stimulation)
measure: Change in Quality of Life Between Baseline and Follow up 1
timeFrame: Baseline and 1 month follow up visit
measure: Change in Quality of Life Between Baseline and Follow up 2
timeFrame: Baseline and 3 month follow up visit
measure: Change in Quality of Life Between Baseline and Follow up 3
timeFrame: Baseline and 6 month follow up visit
measure: Change in Disability Index Between Baseline and Trial Stimulation
timeFrame: Baseline and 1 week after trial lead implant (trial stimulation)
measure: Change in Disability Index Between Baseline and and Follow up 1
timeFrame: Baseline and 1 month follow up visit
measure: Change in Disability Index Between Baseline and and Follow up 2
timeFrame: Baseline and 3 month follow up visit
measure: Change in Disability Index Between Baseline and and Follow up 3
timeFrame: Baseline and 6 month follow up visit
measure: Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation
timeFrame: Baseline and 1 week after trial lead implant (trial stimulation)
measure: Change in Pain Catastrophizing Scale Between Baseline and Follow up 1
timeFrame: Baseline and 1 month follow up visit
measure: Change in Pain Catastrophizing Scale Between Baseline and Follow up 2
timeFrame: Baseline and 3 month follow up visit
measure: Change in Pain Catastrophizing Scale Between Baseline and Follow up 3
timeFrame: Baseline and 6 month follow up visit
Other outcomes:
measure: Stimulation ON/OFF Ratio
timeFrame: 6 month follow up visit
Locations:
city: Santa Rosa
country: United States
facility: Thrive Clinic
state: California
city: Reno
country: United States
facility: Nevada advanced pain specialists
state: Nevada
city: Asheville
country: United States
facility: OnSite Clinical Solutions
state: North Carolina
city: Killeen
country: United States
facility: Ambulatory Surgery Center of Killeen
state: Texas
city: Charleston
country: United States
facility: Premier Pain Solutions
state: West Virginia
Study officials:
affiliation: The Center for Pain Relief
name: Timothy R Deer, MD
role: PRINCIPAL_INVESTIGATOR
References: