ISRCTN11073107进行中（未招募）Unknown
A prospective trial to assess evoked electrical activity above and below spinal cord injury lesions using the EVOKE™ spinal cord stimulator
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. A spinal cord injury (complete or incomplete lesion) of at least 2 years
- •2. Injury at T12/L1 or above
- •3. A disability grade on the American Spinal Injury Association (ASIA) Impairment Scale (AIS) of A, B, C or D as determined by a qualified examiner
- •4. Neuropathic pain as determined clinically by the investigator at or below the level of the SCI
- •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 4 weeks
- •7. Refractoriness to pain treatment as determined by the Investigator (which can include medication and/or other treatment modalities)
- •8. On stable pain medications, as determined by the Investigator, for at least 4 weeks prior to the Baseline Visit
- •9. An appropriate candidate for EVOKE™ Spinal Cord Stimulation implant 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 the time of enrolment
- •12. 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)
- •13. Willing and able to comply with study-related requirements, assessments and visits
- •These decisions are based on the clinical judgement of the investigator.
排除标准
- •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, or severe/critical spinal stenosis
- •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, presence of metalwork)
- •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. Metastatic malignant disease or active local malignant disease
- •9. A life expectancy of less than 1 year
- •10. An active systemic or local infection
- •11. 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)
- •12. Within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
- •13. Benefitting within 30 days prior to enrollment from an interventional procedure and/or surgery to treat the targeted pain area
- •14. Concomitantly participating in another clinical study, or planned to be enrolled in another clinical study
- •Decisions will be based on the clinical judgement of the investigator.
研究者
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