None listed
Conditions
Brief summary
The purpose of the study is to investigate whether a permanent implant of a new spinal cord stimulation system, which uses automatic control, is safe and effective at treating chronic pain of the upper limbs and/or neck. The Stimulator System being investigated in the study is similar to currently available stimulators and treats chronic pain conditions in a similar way. The differences between participating in the study and receiving a currently available stimulator system is that: the System has technology to automatically control the strength of stimulation that you will feel; This type of automatic control stimulation has been studied previously in Australia and the U.S. for lower-back and leg pain. A total of 163 participants have been implanted with the Evoke system so far. All the surgical procedures and medical care in this study are similar to the currently available stimulators. This study is the first time the Evoke system is tested for upper-limb and/or neck pain. The stimulators that will be used during the study (external trial stimulator and implantable stimulator) are investigational devices that are as yet unapproved by the Department of Health, Therapeutic Goods Administration (TGA).
Interventions
This study is a prospective, single arm, open-label study designed to assess the feasibility of using Evoke SCS stimulation in subjects with chronic upper-limb and/or neck pain.
Subjects with chronic, intractable upper-limb/neck pain which has been refractory to conservative therapy for a minimum of 3 months will be screened for participation in this study. Subjects who provide informed consent and meet the study eligibility criteria will first undergo a trial period with the external trial simu
This study is a prospective, single arm, open-label study designed to assess the feasibility of using Evoke SCS stimulation in subjects with chronic upper-limb and/or neck pain. Subjects with chronic, intractable upper-limb/neck pain which has been refractory to conservative therapy for a minimum of 3 months will be screened for participation in this study. Subjects who provide informed consent and meet the study eligibility criteria will first undergo a trial period with the external trial simulator for up to 30 days (typically 1 week) to determine if the subject will be eligible for the permanent implant. The leads will be removed after the trial phase and the external stimulator and the remote control will be returned to the clinic. The trial stimulation phase involves a surgical procedure to place temporary leads (wires) into the spine. The procedure will be undertaken under anaesthesia according to the investigator’s standard practice and you may be sedated for some or the entirety of the procedure. On average, the procedure takes about 1 hour. The simulator will be programmed by a sponsor representative to send electrical signals to help control the pain. This may feel like a tingling sensation. During this phase, subject may return to clinic as often as needed to get the simulator programmed. The programming might be needed for optimal pain coverage or any other technical reason. If subjects failed the trial or don’t proceed to the implant phase, they will be exited from the study. If subject proceed to the implant phase, the procedure will take place in an operating room. The procedure will be undertaken under anaesthesia according to the investigator’s standard practice and subject may be sedated for some or the entirety of the procedure. On average, the procedure takes about 2 hours. Subjects will be followed up at 1-, 3-, 6-, 9-, 12, 18- and 24-months following the permanent implant. At all of the follow-up the following will occur: • Subject need to answer, questions about health, any taken medications/therapies or any changes in medications/therapies since last study visit. • Subject will complete questionnaires that ask about pain, stimulation sensations, sleep, health, physical and emotional well-being, daily activities, and any limitations due to your pain. • The study device will be tested and the settings of the study device will be changed if it is needed.
Sponsors
Saluda Medical
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subject has been diagnosed with chronic, intractable upper-limb/neck pain (VAS score greater or equal to 6), which has been refractory to conservative therapy for at least 6 months and subject’s predominant pain presentation is the upper-limb(s) and/or neck regions; 2. Subject has been approved by the Investigator to undergo a trial of cervical spinal cord stimulation; 3. Subject is an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician; 4. Subject is on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 30 days prior to baseline evaluation; 5. Subject is between 18 to 70 years of age at the time of consent; 6. Subject is willing and capable of giving written informed consent; 7. Subject is willing and able to comply with study-related requirements, procedures, and visits.
Exclusion criteria
1. Subject has 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. Subject is not an SCS candidate due to anatomical or structural findings and/or changes which would benefit from surgical intervention (listhesis, stenosis, mechanical instability, scoliosis) as determined by investigator; 3. Subject has migraine or head pain that is the primary component of their pain syndrome (e.g. cervicogenic headache, post-herpetic neuralgia) headache, or post-herpetic neuralgia in the upper limb; 4. Subject has a history of brachial plexus avulsion; 5. Subject has undergone posterior surgical treatment of the cervical spine; 6. Subject has pain due to peripheral vascular disease or angina; 7. Subject is benefitting from an interventional procedure and/or surgery to treat upper limb pain in the last 30 days prior to baseline the evaluation; 8. Subject has evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcomes as determined by the Investigator; 9. Subject has been diagnosed with a progressive neurological disorder; 10. Subject has a history of significant untreated addiction to dependency-producing medications or have been a substance abuser (including alcohol and/or illicit drugs) in the last 6 months; 11. Subject has an existing or was previously treated with a drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS); 12. Subject is being treated with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (rTMS); 13. Subject has a condition currently requiring or likely to require the use of MRI or diathermy; 14. Subject is not a good surgical candidate (e.g., has an uncontrolled coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, uncontrolled diabetes mellitus, or cannot come off anticoagulant therapy for procedure); 15. Subject has an active systemic or local infection in the area of the surgical site; 16. Subject is allergic, or has shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body; 17. Subject is immunocompromised; 18. Subject is pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control for the duration of the study, be surgically sterile or be at least 2 years post-menopausal); 19. Subject is concomitantly participating in another clinical study unless pre-approved by the sponsor; 20. Subject is involved in a process (e.g., involved in an injury claim under current litigation) in which pain relief may be considered detrimental (i.e., secondary gains); 21. Subject has a life expectancy of less than 2 years.
Outcome results
None listed