None listed
Conditions
Brief summary
The primary objective of this study is demonstrating the performance and safety of EvokeTM spinal cord stimulation with feedback control on neural stimulation in patients with chronic pain with regard to pain relief and stimulation side effects. A new technique has been developed to measure Evoked Compound Action Potentials (ECAPs) or neural responses to neural stimulation, on the same lead that delivers the stimulation. This research will help advance neurostimulation technology.
Interventions
This is a prospective study examining the safety and performance of using neural stimulation incorporating feedback to treat patients with chronic pain. Patients will be diagnosed with chronic pain. All patients will be candidates for stimulation and be scheduled to undergo implantation of a trial lead followed by a trial evaluation. Up to 110 patients will be enrolled (trialled). The assessment of performance against the criterion will be performed at visit 1 (1 month post implant), safety will
This is a prospective study examining the safety and performance of using neural stimulation incorporating feedback to treat patients with chronic pain. Patients will be diagnosed with chronic pain. All patients will be candidates for stimulation and be scheduled to undergo implantation of a trial lead followed by a trial evaluation. Up to 110 patients will be enrolled (trialled). The assessment of performance against the criterion will be performed at visit 1 (1 month post implant), safety will be assessed by analysis of AEs throughout the study period. The performance criterion defined by the sponsor is based upon successful delivery of neuromodulation in feedback mode in 80% of implanted patients (i.e. patients who have successfully passed the trial phase and proceed to surgery for the fully implanted system). After eligible patients have signed informed consent and baseline data will be collected. They will be enrolled in the study when they undergo implantation of trial stimulation leads. This procedure, performed by pain specialist, will be followed by a trial of stimulation (7- 10 days period) using the EvokeTM External Closed Loop Stimulator (eCLS). During this period various parameters will be tested and ECAPSs will be recorded. Feedback will be assessed and may be used. Patients who have had a successful trial, success is determined by a 40% reduction in pain using the visual analogue scale, will then be implanted with the EvokeTM Closed Loop Stimulator (CLS). Patients will return to the clinic for evaluations 1 month + 7 days, 3 months + 14 days, 6 months + 14 days, 12 months + 21 days, 15 months + 28 days, 18 months + 28 days, 21 months + 28 days, and 24 months + 28 days post implantation. Evaluations will include measures of pain, functional disability, quality of life, patient satisfaction and paresthesia characteristics. All adverse events will be recorded. Patients may be asked to have their evaluations videotaped. This will involve the patient signing an additional consent. At the end of the study, patient may be able to continue Spinal Cord Stimulation with his implanted device if it is found to be of benefit to him in treating his pain. This decision will be made in consultation between patient and his treating doctor.
Sponsors
Saluda Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients selected for this study must meet the following inclusion criteria: 1. Have been diagnosed with chronic, intractable pain (VAS = 6 for the past week), which has been refractory to conservative therapy for a minimum of 3 months. 2. Have been approved to undergo a trial of neural stimulation. Neural stimulation can include cervical or thoracic spinal cord stimulation. 3. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician 4. Be on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 4 weeks prior to the trial 5. Be 18 years of age or older at the time of enrolment 6. Be willing and capable of giving written informed consent 7. Be willing and able to comply with study-related requirements, procedures, and visits. 8. Females of childbearing age must have a negative urine pregnancy test at baseline
Exclusion criteria
Patients selected for this study must not meet the following exclusion criteria: 1. Have a medical condition or pain in area(s) that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator 2. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with of intervention and/or ability to evaluate treatment outcomes 3. Are not a surgical candidate due to a diagnosis of an uncontrolled coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus 4. Have an implanted pacemaker and/or another SCS system that may interfere with the Saluda system. 5. Have a condition currently requiring or likely to require the use of MRI or diathermy 6. Have a life expectancy of less than 1 year 7. Have an active systemic or local infection 8. Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body 9. Be pregnant or nursing (if female and sexually active, participant must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal) 10. Have within 6 months of enrolment a significant untreated addiction to dependency-producing medications or have been a substance abuser (including alcohol and/or illicit drugs) 11. Be concomitantly participating in another clinical study 12. Be involved in an injury claim under current litigation
Outcome results
None listed