Leg Pain, Low Back Pain, Upper Limb Pain
Conditions
Brief summary
The purpose of the study is to further understand the closed-loop feature in chronically implanted patients by characterizing the efficacy of the next generation, spinal cord stimulator.
Interventions
DEVICEInceptiv
Implantable Neurostimulator with Neuro Sense
Sponsors
MedtronicNeuro
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
* 18 years of age or older * Candidate is undergoing Medtronic SCS device trial for chronic, intractable pain of the trunk and/or limbs * If being treated for low-back and/or leg pain, * the baseline overall\^ Visual Analog Scale is ≥ 60 mm and * baseline back and/or leg pain Visual Analog Scale is ≥60 mm. \^Average overall pain in the back and/or leg in the 72 hours prior to the baseline visit, measured using Visual Analog Scale. * If being treated for upper limb pain - baseline Visual Analog Scale is ≥ 60 mm for upper limb pain * On stable (no change in dose, route, or frequency) prescribed pain medications being used for back and leg pain or upper limb pain, as determined by the investigator, for at least 28 days prior to device trial * Willing and able to provide signed and dated informed consent * Willing and able to comply with all study procedures and visits
Exclusion criteria
* Indicated for an SCS device to treat stable intractable Angina Pectoris or Peripheral Vascular Disease of Fontaine Stage III or higher * Previously trialed or implanted with spinal cord stimulator, peripheral or vagus nerve stimulator, deep brain stimulator or an implantable intrathecal drug delivery system * Currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team * Major psychiatric comorbidity or other progressive diseases that may confound study results, as determined by the Investigator * Serious drug-related behavioral issues (e.g. alcohol dependency, illegal substance abuse), as determined by the Investigator * Pregnant or planning on becoming pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal) * Be involved in an injury claim or under current litigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Overstimulation Sensation | 30 days from device activation | The primary outcome is the proportion of low-back and/or leg pain subjects whose average overstimulation intensity score with Closed Loop On is less than their average overstimulation intensity score with Closed Loop Off. During in-clinic testing, subjects perform protocol prescribed activities and rate the intensity of the sensations on a 5-point Likert scale with both Closed Loop On and Off. The average overstimulation intensity scores within each subject are calculated separately for Closed Loop On and Off, and the proportion of subjects with a lower average overstimulation intensity score during Closed Loop On compared to their overstimulation intensity score during Closed Loop Off is calculated with a one-sided 97.5% lower bound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate for Treatment of Overall Pain | 3 months from device activation | Responder rate defined as a reduction in Overall (back/leg) pain VAS of at least 50%. |
| Responder Rate for Treatment of Low-back Pain | 3 months from device activation | Responder rate defined as a reduction in back pain VAS of at least 50%. |
| Responder Rate for Treatment of Leg Pain | 3 months from device activation | Responder rate defined as a reduction in leg pain VAS of at least 50%. |
Countries
Australia
Participant flow
Pre-assignment details
94 subjects were enrolled. 19 exited prior to the SCS trial. 75 started the trial with 2 subjects not completing the trial and 4 subjects experiencing an unsuccessful trial. Of the 69 that had a successful trial, 9 exited before implant and 60 were implanted. All implanted subjects received SCS therapy following device activation, and subjects with clear and measurable Evoked Compound Action Potentials (ECAPs) had the option to turn the closed loop feature On.
Participants by arm
| Arm | Count |
|---|---|
| All Implanted Subjects Enrolled subjects who are implanted with a spinal cord stimulation system. Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with closed loop feature capabilities. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 30-day Visit to 3-Month Visit | Adverse Event | 1 |
| Implant to 30-day Visit | Lack of compliance to the protocol including phone calls & optimisation visits. | 1 |
| Implant to 30-day Visit | Physician Decision | 1 |
| Implant to 30-day Visit | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Implanted Subjects |
|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 14.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Primary Indication Complex Regional Pain Syndrome | 4 Participants |
| Primary Indication Degenerative Disk Disease | 23 Participants |
| Primary Indication Failed Back Syndrome | 20 Participants |
| Primary Indication Peripheral Causalgia | 1 Participants |
| Primary Indication Post Laminectomy Pain | 4 Participants |
| Primary Indication Radicular Pain Syndrome | 5 Participants |
| Primary Indication Unsuccessful Disk Surgery | 3 Participants |
| Primary Location of Pain Low-Back and/or Leg Pain | 57 Participants |
| Primary Location of Pain Upper Limb Pain | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 33 Participants |
| Years Since Onset of Pain | 10.1 years STANDARD_DEVIATION 9.69 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 3 / 60 |
| serious Total, serious adverse events | 10 / 60 |
Outcome results
Primary
Reduction in Overstimulation Sensation
The primary outcome is the proportion of low-back and/or leg pain subjects whose average overstimulation intensity score with Closed Loop On is less than their average overstimulation intensity score with Closed Loop Off. During in-clinic testing, subjects perform protocol prescribed activities and rate the intensity of the sensations on a 5-point Likert scale with both Closed Loop On and Off. The average overstimulation intensity scores within each subject are calculated separately for Closed Loop On and Off, and the proportion of subjects with a lower average overstimulation intensity score during Closed Loop On compared to their overstimulation intensity score during Closed Loop Off is calculated with a one-sided 97.5% lower bound.
Time frame: 30 days from device activation
Population: The pre-specified Primary Analysis Set includes the first 28 low-back and/or leg pain subjects within the All Implanted Subjects Arm with clear and measurable Evoked Compound Action Potentials (ECAPs) who completed in-clinic testing at the 30-day visit. Of the 60 implanted subjects, 2 missed the 30-day visit, 55 completed the 30-day visit, 50 had low-back and/or leg pain and clear and measurable ECAPs, and the first 28 of these subjects are included in the analysis for this objective.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Implanted Subjects | Reduction in Overstimulation Sensation | 25 Participants |
p-value: <0.001Binomial Exact Test
Secondary
Responder Rate for Treatment of Leg Pain
Responder rate defined as a reduction in leg pain VAS of at least 50%.
Time frame: 3 months from device activation
Population: All implanted subjects with leg pain (baseline VAS ≥ 60mm) who have data at baseline and the 3-month visit. As all subjects were implanted with a spinal cord stimulation system with closed loop feature capabilities, the analysis was pre-specified in the statistical analysis plan to report the combined responder rate for these subjects with data at baseline and the 3-month visit, regardless of whether in-clinic testing of the closed loop feature had been conducted at the 30-day visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Implanted Subjects | Responder Rate for Treatment of Leg Pain | 30 Participants |
Secondary
Responder Rate for Treatment of Low-back Pain
Responder rate defined as a reduction in back pain VAS of at least 50%.
Time frame: 3 months from device activation
Population: All implanted subjects with low-back pain (baseline VAS ≥ 60mm) who have data at baseline and the 3-month visit. As all subjects were implanted with a spinal cord stimulation system with closed loop feature capabilities, the analysis was pre-specified in the statistical analysis plan to report the combined responder rate for these subjects with data at baseline and the 3-month visit, regardless of whether in-clinic testing of the closed loop feature had been conducted at the 30-day visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Implanted Subjects | Responder Rate for Treatment of Low-back Pain | 38 Participants |
Secondary
Responder Rate for Treatment of Overall Pain
Responder rate defined as a reduction in Overall (back/leg) pain VAS of at least 50%.
Time frame: 3 months from device activation
Population: All implanted subjects with low-back and/or leg pain who have data at baseline and the 3-month visit. As all subjects were implanted with a spinal cord stimulation system with closed loop feature capabilities, the analysis was pre-specified in the statistical analysis plan to report the combined responder rate for these subjects with data at baseline and the 3-month visit, regardless of whether in-clinic testing of the closed loop feature had been conducted at the 30-day visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Implanted Subjects | Responder Rate for Treatment of Overall Pain | 44 Participants |