- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03350256
BurstDR™ micrOdosing stimuLation in De-novo Patients (BOLD)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Santa Rosa, California, United States, 95403
- Thrive Clinic
-
-
Nevada
-
Reno, Nevada, United States, 89511
- Nevada Advanced Pain Specialists
-
-
North Carolina
-
Asheville, North Carolina, United States, 28803
- OnSite Clinical Solutions
-
-
Texas
-
Killeen, Texas, United States, 76542
- Ambulatory Surgery Center of Killeen
-
-
West Virginia
-
Charleston, West Virginia, United States, 25301
- Premier Pain Solutions
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Microdosing group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation
Time Frame: baseline and 1 week after trial lead implant (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
Time Frame: Baseline and 1 month follow up visit
|
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
Time Frame: Baseline and 3 month follow up visit
|
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
Time Frame: Baseline and 6 month follow up visit
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quality of Life Between Baseline and Trial Stimulation
Time Frame: Baseline and 1 week after trial lead implant (trial stimulation)
|
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
|
Baseline and 1 week after trial lead implant (trial stimulation)
|
Change in Quality of Life Between Baseline and Follow up 1
Time Frame: Baseline and 1 month follow up visit
|
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
|
Baseline and 1 month follow up visit
|
Change in Quality of Life Between Baseline and Follow up 2
Time Frame: Baseline and 3 month follow up visit
|
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
|
Baseline and 3 month follow up visit
|
Change in Quality of Life Between Baseline and Follow up 3
Time Frame: Baseline and 6 month follow up visit
|
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
|
Baseline and 6 month follow up visit
|
Change in Disability Index Between Baseline and Trial Stimulation
Time Frame: Baseline and 1 week after trial lead implant (trial stimulation)
|
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
|
Baseline and 1 week after trial lead implant (trial stimulation)
|
Change in Disability Index Between Baseline and and Follow up 1
Time Frame: Baseline and 1 month follow up visit
|
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
|
Baseline and 1 month follow up visit
|
Change in Disability Index Between Baseline and and Follow up 2
Time Frame: Baseline and 3 month follow up visit
|
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
|
Baseline and 3 month follow up visit
|
Change in Disability Index Between Baseline and and Follow up 3
Time Frame: Baseline and 6 month follow up visit
|
questionnaire on disability (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
|
Baseline and 6 month follow up visit
|
Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation
Time Frame: Baseline and 1 week after trial lead implant (trial stimulation)
|
Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
|
Baseline and 1 week after trial lead implant (trial stimulation)
|
Change in Pain Catastrophizing Scale Between Baseline and Follow up 1
Time Frame: Baseline and 1 month follow up visit
|
Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
|
Baseline and 1 month follow up visit
|
Change in Pain Catastrophizing Scale Between Baseline and Follow up 2
Time Frame: Baseline and 3 month follow up visit
|
Questionnaire on pain catastrophizing (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
|
Baseline and 3 month follow up visit
|
Change in Pain Catastrophizing Scale Between Baseline and Follow up 3
Time Frame: Baseline and 6 month follow up visit
|
Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
|
Baseline and 6 month follow up visit
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stimulation ON/OFF Ratio
Time Frame: 6 month follow up visit
|
Percentage of patients using each ON/OFF ratio
|
6 month follow up visit
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Timothy R Deer, MD, The Center for Pain Relief
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SJM-CIP-10215
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain, Intractable
-
Abbott Medical DevicesWithdrawnChronic Intractable PainUnited Kingdom, Canada
-
MedtronicNeuroTerminatedChronic Intractable PainUnited States
-
Flowonix MedicalCompleted
-
Universitaire Ziekenhuizen KU LeuvenUnknownStudying Spinal Cord Evoked Potentials in Patients With Intractable Pain.Belgium
-
Institut Cancerologie de l'OuestCompletedAdvanced Cancer | Intractable PainFrance
-
Abbott Medical DevicesCompletedChronic Pain | Intractable PainSpain, Canada, United States, Finland, Germany, Italy, Switzerland
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University of Wisconsin, MadisonCompleted
-
Abbott Medical DevicesCompletedChronic, Intractable Pain of the Trunk and/or Lower LimbsUnited States, Australia, Netherlands, Sweden, Germany, Italy, Austria
-
Abbott Medical DevicesTerminated
Clinical Trials on Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.
-
Memorial Sloan Kettering Cancer CenterPfizer; Dana-Farber Cancer Institute; University of Pittsburgh; University of VirginiaCompletedNeurofibromatosis | Meningioma | CNS Cancer | Hemangioblastoma | Intracranial HemangiopericytomaUnited States
-
Memorial Sloan Kettering Cancer CenterTufts Medical Center; Lahey ClinicCompleted