Back Pain, Chronic Pain, Pain
Conditions
Keywords
Chronic Pain, Back Pain, Leg Pain, Pain, Neurologic Manifestations, Nervous System Diseases, Signs and Symptoms, SCS, Closed Loop
Brief summary
The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.
Interventions
A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Sponsors
Saluda Medical Pty Ltd
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
* Subject has chronic intractable pain of the trunk and/or limbs. * Subject is willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.
Exclusion criteria
* Subject is unable to operate the system. * Subject is an unsuitable surgical candidate. * Subject has a condition currently requiring or likely to require the use of diathermy. * Subject has another implantable stimulator such as demand type pacemakers or cardioverter defibrillator. * Subject is \<18 years old. * Subject is pregnant or nursing. * Subject is allergic, or has shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body. * Subject is being treated with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (rTMS).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System | 12-months post-implant | Dose ratio is determined by the estimated current (mA) at the median ECAP level divided by the current (mA) at the ECAP threshold. The dose ratio allows for both the individualization of a patient's neural dose and comparison across patients, using their ECAP threshold and unique dose response. This metric normalizes for distance between the electrode and the spinal cord and the distances between the stimulation and recording electrodes. The dose ratio reflects the amount of dorsal column activation elicited by stimulation with respect to threshold levels. For example, if the dose is at ECAP threshold, this value will be 1. If the dose is 30% higher than ECAP threshold, this value will be 1.3. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in PROMIS-29 | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant | 29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity. |
| Change in PROMIS-10 Global | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant | 10-item instrument that assesses Physical Health and Mental Health |
| Change in Pain | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant | Visual Analogue Scale (VAS) to rate pain intensity |
| Rate of Patient Global Impression of Change (PGIC) | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant | Single item measure of global improvement with treatment |
| Rate of Patient Satisfaction With Therapy | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant | Single item measure of satisfaction with treatment |
| Change in Profile of Mood States (POMS 2-A Short) | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant | 35-item instrument that assesses mood states overall (Total Mood Disturbance) and six mood clusters: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. A scale score is also calculated for Friendliness. |
Countries
United States
Participant flow
Pre-assignment details
Single-arm study. Subjects undergo a trial with the device, at which point they are enrolled, prior to receiving a permanent implant. Results are for implanted subjects.
Participants by arm
| Arm | Count |
|---|---|
| ECAP-controlled, Closed-loop SCS Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Evoke Spinal Cord Stimulation (SCS) System: A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude | 231 |
| Total | 231 |
Baseline characteristics
| Characteristic | ECAP-controlled, Closed-loop SCS |
|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 218 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 2 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 | 217 Participants |
| Region of Enrollment United States | 231 participants |
| Sex: Female, Male Female | 126 Participants |
| Sex: Female, Male Male | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 300 |
| other Total, other adverse events | 59 / 300 |
| serious Total, serious adverse events | 38 / 300 |
Outcome results
Primary
Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System
Dose ratio is determined by the estimated current (mA) at the median ECAP level divided by the current (mA) at the ECAP threshold. The dose ratio allows for both the individualization of a patient's neural dose and comparison across patients, using their ECAP threshold and unique dose response. This metric normalizes for distance between the electrode and the spinal cord and the distances between the stimulation and recording electrodes. The dose ratio reflects the amount of dorsal column activation elicited by stimulation with respect to threshold levels. For example, if the dose is at ECAP threshold, this value will be 1. If the dose is 30% higher than ECAP threshold, this value will be 1.3.
Time frame: 12-months post-implant
Population: patients who completed the 12-month follow-up visit
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ECAP-controlled, Closed-loop SCS | Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System | 1.3 ratio |
Other Pre-specified
Change in Pain
Visual Analogue Scale (VAS) to rate pain intensity
Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Other Pre-specified
Change in Profile of Mood States (POMS 2-A Short)
35-item instrument that assesses mood states overall (Total Mood Disturbance) and six mood clusters: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. A scale score is also calculated for Friendliness.
Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Other Pre-specified
Change in PROMIS-10 Global
10-item instrument that assesses Physical Health and Mental Health
Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Other Pre-specified
Change in PROMIS-29
29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity.
Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Other Pre-specified
Rate of Patient Global Impression of Change (PGIC)
Single item measure of global improvement with treatment
Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Other Pre-specified
Rate of Patient Satisfaction With Therapy
Single item measure of satisfaction with treatment
Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant