Chronic Pain
Conditions
Keywords
stimulation, implantable, pulse generator, back pain, chronic pain, leg pain
Brief summary
This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study to characterize the effects of programming features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator (SCS) System using the CoverEdge™ surgical lead.
Interventions
DEVICEPrecision Spectra™ SCS system programming features
Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject implanted, on-label, with a commercially approved Boston Scientific Spectra neurostimulation system and at least one CoverEdge or CoverEdge X surgical lead, per local directions for use (DFU). * Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form. * Subject is 18 years of age or older when written informed consent is obtained.
Exclusion criteria
* Subject meets any contraindication in Boston Scientific (BSC) neurostimulation system local DFU. * Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire | minimum 25 days post IPG implant | Change in paresthesia distribution based on programming parameters |
Countries
United States
Participant flow
Pre-assignment details
15 subjects were enrolled in the study. 1 subject was enrolled in error who did not meet all inclusion criteria and was withdrawn and 1 subject was lost to follow-up prior to completing the Programming Visit. Statistically relevant conclusions cannot be made from this small sample size.
Participants by arm
| Arm | Count |
|---|---|
| Precision Spectra™ SCS System Programming Features Precision Spectra™ SCS system programming features using the CoverEdge surgical lead. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Precision Spectra™ SCS System Programming Features |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire
Change in paresthesia distribution based on programming parameters
Time frame: minimum 25 days post IPG implant
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Precision Spectra™ SCS System Programming Features | Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire | Yes | 13 Participants |
| Precision Spectra™ SCS System Programming Features | Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire | No | 0 Participants |