Spinal cord injury Nervous System Diseases Spinal cord injury
Conditions
Sponsors
Nevro Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A spinal cord injury (complete or incomplete lesion) of at least 2 years 2. Injury at cervical/thoracic/lumbar/sacral level 3. A disability grade on the American Spinal Injury Association (ASIA) Impairment Scale (AIS) of A, B, C,D or E as determined by a qualified examiner 4. Neuropathic pain as clinically determined by the investigator 5. Average pain intensity for the target pain area of = 5 out of 10 cm on the Visual Analogue Scale (VAS) at enrollment when the patient is taking medication 6. Stable chronic pain for at least 3 months 7. Refractoriness to pain treatment as determined by the Investigator1 (which can include medication and/or other treatment modalities) 8. On stable pain medications, as determined by the Investigator1, for at least 4 weeks prior to the Baseline Visit 9. An appropriate candidate for HF10™ Spinal Cord Stimulation as determined by the Investigator 10. An appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician and if applicable per the local regulations 11. An adult (= 18 years of age) at time of enrollment 12. Evaluated at the investigational site at least once prior to screen for the pain condition related to the study 13. Willing and capable of giving written informed consent prior to any investigational related procedure (if not able to write consent will happen through legal or personal representative) 14. Willing and able to comply with study-related requirements, assessments and visits 15. Capable of subjective evaluation, able to read and understand written questionnaires, and are able to read, understand and sign the written inform consent (see Inclusion criterion 13, legal/personal representative) 16. Adequate cognitive ability and sufficient support (e.g. caregiver) to use a patient external trial stimulator, recharger and patient remote as determined by the Investigator
Exclusion criteria
Exclusion criteria: 1. 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 the investigator in consultation with a clinical psychologist 2. A current diagnosis of a progressive neurological disease such as multiple sclerosis, inflammatory, infective, vascular, demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor 3. An invalid AIS (e.g. ASIA motor exam not obtainable) 4. A current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the investigator 5. A diagnosis that precludes lead placement (e.g. severe scoliosis) 6. Radiographic evidence of spinal instability requiring fusion as determined by the Investigator 7. Previous and/or current experience with drug pump and/or neurostimulator or another active implantable device such as a pacemaker 8. A condition currently requiring or likely to require the use of MRI of the trunk 9. Metastatic malignant disease or active local malignant disease 10. A life expectancy of less than 1 year 11. An active systemic or local infection 12. Pregnant (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) 13. Within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs) 14. Benefitting within 30 days prior to enrollment from an interventional procedure and/or surgery to treat the targeted pain area 15. Concomitantly participating in another clinical study, or planned to be enrolled in another clinical study 16. Involved in an injury claim under current litigation 17. A pending worker’s compensation claim as determined by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Targetted pain area directly related to SCI is measured using the Visual Analog Scale (VAS) at baseline, end of SCS trial period, 1, 3, 6, 9 and 12 month visits *target pain area: neuropathic pain following SCI (at-level and below-level) 2. Neurological level and/or sensorimotor state is measured using the ASIA Impairment Scale at baseline, 3, 6 and 12 months 3. Neurological pain is measured using the Douleur Neuropathique 4 (DN-4) questionnaire at baseline, end of SCS trial period, 3, 6 and 12 month 4. Spasticity is measured using the Modified Ashworth Scale and Penn Spasm Frequency Scale at baseline, end of SCS trial period, 3, 6, 9 and 12 months 5. Disability is measured using the Spinal Cord Independence Measure (SCIM) at baseline, end of SCS trial period, 3, 6 and 12 months 6. Health status is measured using the European Quality of Life-5 Dimensions (EQ-5D-5L) questionnaire at baseline, v, 3, 6, 9 and 12 months 7. General state of health is measured using the Patient Global Impression of Change (PGIC) instrument at the end of SCS trial period, 1, 3, 6, 9 and 12 months 8. General state of health is measured using the Clinician* Global Impression of Change (CGIC) instrument at the end of SCS trial period, 1, 3, 6, 9 and 12 months *Clinician: both pain physician and SCI specialist to complete 9. Depression is measured using the Beck Depression Inventory II (BDI-II) at baseline, end of SCS trial period, 3, 6 and 12 months 10. Sleep disturbance is measured using the Pain and Sleep Questionnaire three-item Index (PSQ-3) at baseline, end of SCS trial period, 3, 6, 9 and 12 months 10. Medication usage is observed at baseline, end of SCS trial period, 3, 6, 9 and 12 months 11. Participant satisfaction with the therapy is measured using the Subject Satisfaction qu | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Contacts
Public ContactBrad Gliner
Outcome results
None listed