Chronic Pain, Intractable Pain, Low Back Pain, Pain, Back, Pain, Neuropathic
Conditions
Brief summary
The purpose of the study is to assess the feasibility of using information extracted from physiologic signals to automatically adjust stimulation in patients undergoing Spinal Cord Stimulation (SCS).
Interventions
DEVICESpinal Cord Stimulation
Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Study candidate is undergoing a temporary SCS trial of commercially approved BSC neurostimulator system, per local directions for use (DFU). * Subject signed a valid, EC/IRB-approved informed consent form. * Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law when written informed consent is obtained. * In the clinician best judgment, subject is able to distinguishably describe quality and location of sensation and pain. Key
Exclusion criteria
* Subject meets any contraindication in BSC neurostimulation system local DFU. * Investigator-suspected gross lead migration during the SCS trial period which may preclude the study candidate from receiving adequate SCS therapy. * Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that in the clinician's best judgement would limit study candidate's ability to assess and report sensation information. * Subject is currently diagnosed with a physical impairment, or exhibits a condition that would limit study candidate's ability to complete study assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perception Threshold | Programming Visit (up to 15 days post-screening) | Percent change in patient's perceiving spinal cord stimulation (i.e. Perception Threshold) when going from a reclining to sitting position in a reclining chair |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Cord Stimulation SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.
Spinal Cord Stimulation: Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Spinal Cord Stimulation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Black, of African Heritage | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 17 Participants |
| Race/Ethnicity, Customized Native American | 1 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Perception Threshold
Percent change in patient's perceiving spinal cord stimulation (i.e. Perception Threshold) when going from a reclining to sitting position in a reclining chair
Time frame: Programming Visit (up to 15 days post-screening)
Population: Subjects who received programming with SCS trial neurostimulator system.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Stimulation | Perception Threshold | 157 percent change in perception threshold | Standard Deviation 52 |