None listed
Conditions
Brief summary
This is a multi-center, prospective, study to collect data on the commercially available Nevro Senza SCS System. Outcomes will be assessed via standardized assessments (trial and IPG implant procedures are part of routine practice). The purpose of this study is to document and assess safety and effectiveness of HF10 electrical stimulation delivered to the spinal cord in subjects with chronic, intractable pain of the upper limb and neck, as part of the centers’ routine practice (on-label use of TGA approved/CE marked device). Data at follow-up visits will be compared to Baseline data collected at the beginning of the study. This study includes extensive data collection (Trial and IPG implant procedures are part of routine practice). Subjects will participate in this investigational plan that includes entry criteria evaluation, baseline assessments, trial stimulation phase, and post-trial assessment. Subjects with a successful Trial Phase will be implanted a permanent system (i.e. IPG) and leads as per center’s routine practice, and undergo 12 months of stimulation delivery with assessments at 1, 3, 6, 9, and 12 months Post-Permanent Device Activation. Assessments of pain and adverse events will be made at 1 month and 9 months following Post-Permanent Device Activation. At 3, 6, and 12 months Post-Permanent Device Activation, subjects will be assessed for pain and adverse events as well as disability, functioning, neurological assessment, medication use, quality of life, depression and sleep. Patient Global Impression of Change, Clinician Global Impression of Change and subject satisfaction will be recorded at 3 and 12 months Post-Permanent Device Activation.
Interventions
Spinal Cord Stimulation
Subjects will undergo implantation of leads in the epidural space of the spinal column. Electrical stimulation will be applied constantly via an external trial stimulator (TSM) for approximately 7 days to determine if stimulation is helpful in the relief of pain of the upper limbs and/or neck. If the patient and physician feel the stimulation is effective (standard pain assessment tools will be used), the patient will undergo permanent implantation of leads and implantabl
Spinal Cord Stimulation Subjects will undergo implantation of leads in the epidural space of the spinal column. Electrical stimulation will be applied constantly via an external trial stimulator (TSM) for approximately 7 days to determine if stimulation is helpful in the relief of pain of the upper limbs and/or neck. If the patient and physician feel the stimulation is effective (standard pain assessment tools will be used), the patient will undergo permanent implantation of leads and implantable pulse generator (IPG). The device can be reprogrammed by personnel at the physician's office to optimize therapy. During reprogramming, usage statistics are available to the physician. Permanent implant surgery: As with other SCS procedures, a Touhy needle is inserted into the back at a location determined by the physician and the lead is passed through the needle into the spinal space. Once the lead tip is located in the area the physician deems appropriate (based on location of the patient's pain), the lead is anchored and sutured in place. The other end of the lead is then tunneled under the skin to the area of the body the physician deems appropriate for IPG placement. A pocket is created at that location to accommodate the IPG. The leads are connected to the IPG and all incisions are sutured. All system components are implanted. This procedure lasts 30-90 minutes. Temporary trial: For the trial phase, a Touhy needle is inserted into the back at a location determined by the physician and the lead is passed through the needle into the spinal space untilthe lead tip is located in the area the physician deems appropriate (based on location of the patient's pain). When the trial is temporary, the leads are not anchored down. The other end of the lead is externalized and connected to the trial stimulator for the duration of the trial. Appropriate steps are taken to ensure sterility. This procedure lasts 30-60 minutes.
Sponsors
Nevro Corp
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
1. Have been diagnosed with chronic, intractable pain of the upper limb and/or neck related to the cervical spine and/or neuropathic arm pain. 2. Considering daily activity and rest, have average upper limb or neck pain intensity of greater than or equal to 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment. 3. Be an appropriate candidate for HF10 SCS.
Exclusion criteria
1. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study assessments , accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache diagnosis and fibromyalgia). 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 outcome, as determined by a psychologist. 3. Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe cervical spinal stenosis and brachial plexus injury as determined by the investigator. 4. Having pain in the shoulder girdle or arm with a primary etiology due to a shoulder pathology. 5. Have a current diagnosis of a coagulation disorder, bleeding diathesis that would put patient at any increased risk of bleeding during SCS procedure, progressive peripheral vascular disease or uncontrolled diabetes mellitus. 6. Having any clinical evidence mechanical instability or progressive neurologic pathology that warrants surgical intervention. Neurologic pathology related to severe or critical cervical spondylosis including spinal stenosis (AP diameter <10 mm), myelomalacia not related to a previously corrected stenosis, radiculopathy manifest clinically by motor deficit in setting of anatomic etiology (herniated nucleus pulposis). 7. Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) that would disrupt/obliterate the posterior epidural space.
Outcome results
None listed