None listed
Conditions
Brief summary
The primary objective of this study is demonstrating the effectiveness of feedback control on neural stimulation in patients with chronic pain with regard to pain relief and stimulation side effects in an extended trial. 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. Three devices have been developed to measure ECAPs and provide feedback control of stimulation current in patients undergoing a trial of SCS for the relief of chronic pain: Multi-Channel System (MCS), Body Worn System (BWS) and an External Trial System (ETS). All the participants may be tested with all these devices. MCS is not a portable system and is used in the operating room or at the clinic. BWS and ETS are similar and used for ambulatory testing, however due to short battery life of the BWS, this device will be used for ambulatory testing at the clinic and ETS is used as a take home device for an extended trial. This research will help advance neurostimulation technology.
Interventions
Potential participants will be patients of the Investigator who have decided to trial neurostimulation during a consultation discussion regarding treatment options for their pain. Trialling Spinal cord stimulation involves implanting one or two spinal lead which normally takes less than an hour. Minimal sedation will be used during the procedure. The patient needs to be alert and communicative ensuring intraoperative testing to ensure proper positioning of the leads.
If they patient decided to t
Potential participants will be patients of the Investigator who have decided to trial neurostimulation during a consultation discussion regarding treatment options for their pain. Trialling Spinal cord stimulation involves implanting one or two spinal lead which normally takes less than an hour. Minimal sedation will be used during the procedure. The patient needs to be alert and communicative ensuring intraoperative testing to ensure proper positioning of the leads. If they patient decided to trial the spinal cord stimulation, they will then be told about the study and given the Participant Information Sheet and Consent Form to take home and read. If they agree to participate in the study, they will be tested using experimental stimulators. This experimental neurostimulator will either be a multi-channel system (MCS) used in the operating theatre and clinic, or an external trial system (ETS) that they will wear at home. A second form of the ETS is the body worn system (BWS) that would only be used for testing in the clinic for ambulatory tests. Following the minimum 3 day trial with their commercial stimulation, patients will be programed with feedback control and they will go home with this program using ETS. Patients can have ETS for up to 25 days. The intensity of stimulation automatically adjusted to the comfort level of the patient using the feedback control loop. Patient can choose to have the stimulation ON all the time during the trial or for some certain time during day. In each follow-up visit (every 5-7 days), their wound will be checked and they will be asked to answer some basic questions about their pain level and their experience with stimulation. At the final visit, ETS will be disconnected from the lead and lead will be removed by a clinician. Patients may have another visit for some neurophysiological measurements using the experimental stimulators. This is an optional visit which can be done at any time.
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 enrolled in this study must meet the following inclusion criteria: 1. Have been diagnosed with chronic, intractable pain, 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 spinal cord stimulation (cervical, thoracic or sacral), peripheral nerve stimulation (such as occipital or sacral nerves), dorsal root, or dorsal root ganglion. 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.
Exclusion criteria
Patients enrolled in 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 of intervention and/or ability to evaluate treatment outcomes 3. Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus 4. Have a diagnosis of scoliosis that precludes lead placement in epidural space (for SCS patients only) 5. Have an existing drug pump and/or neural stimulation system or another active implantable device such as a pacemaker 6. Have a condition currently requiring or likely to require the use of MRI or diathermy 7. Have pain due to a malignant disease 8. Have a life expectancy of less than 1 year 9. Have an active systemic or local infection 10. Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body 11. Be pregnant or nursing (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) 12. 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) 13. Be concomitantly participating in another clinical study 14. Be involved in an injury claim under current litigation
Outcome results
None listed