Neurophysiological Effects of Pain Medication Reduction During Treatment With Closed-Loop Spinal Cord Stimulation: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Spinal cord sensitivity expressed in ECAP amplitude (µV) as a function of the SCS stimulation amplitude (mA).
研究概览
简要总结
This pilot study investigates the effects of reducing pain medication including opioids and anticonvulsants, on spinal cord sensitivity during closed-loop spinal cord stimulation (SCS). Patients with Persistent Spinal Pain Syndrome Type 2 (FBSS/FNSS) will undergo a standard 21-day SCS trial with the Evoke closed-loop system, followed by permanent implantation if successful. Neurophysiological responses (activation plots, conduction velocity, chronaxie, rheobase) and patient-reported outcomes (VAS, activity, sleep, medication intake) will be collected during the trial and up to 6 months after implantation. The goal is to evaluate the relationship between medication tapering and spinal cord sensitivity
详细描述
This is a single-centre, open-label, prospective pilot study in Belgium. Twenty patients scheduled for SCS with the Evoke ECAP-controlled closed-loop system will be enrolled. Eligible patients must use at least one qualifying pain medication at a minimum daily dose (gabapentin ≥150 mg, pregabalin ≥75 mg, morphine ≥40 mg, hydromorphone ≥10 mg, oxycodone ≥20 mg, fentanyl ≥25 µg).
The study includes baseline assessments, a 3-week trial period, permanent implantation if successful, and follow-up visits at 1, 3, and 6 months. Data collected include VAS pain, sleep, activity, medication use, and neurophysiological parameters (activation plots, conduction velocity, chronaxie, rheobase).
The primary endpoint is the effect of medication reduction on spinal cord sensitivity to SCS. Secondary endpoints include changes in pain intensity, medication use, sleep, activity, and additional neurophysiological outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidate for SCS and scheduled for trial with Evoke system.
- •Diagnosis of FBSS or FNSS (PSPS-T2).
- •Current use of ≥1 qualifying pain medication at or above minimum daily dose:
- •Gabapentin ≥150 mg
- •Pregabalin ≥75 mg
- •Morphine ≥40 mg
- •Hydromorphone ≥10 mg
- •Oxycodone ≥20 mg
- •Fentanyl ≥25 µg
- •Signed informed consent.
- •Age ≥18 years.
排除标准
- •Active disruptive psychiatric disorder or condition impacting pain perception or compliance.
- •Progressive neurological disease (MS, CIDP, progressive arachnoiditis, progressive diabetic neuropathy, brain/spinal tumor, severe spinal stenosis).
- •Coagulation disorder, platelet dysfunction, progressive vascular disease, or uncontrolled diabetes with procedural risk.
- •Active systemic or local infection.
- •Pregnancy.
- •Significant untreated addiction or substance abuse (within 6 months prior)
结局指标
主要结局
Spinal cord sensitivity expressed in ECAP amplitude (µV) as a function of the SCS stimulation amplitude (mA).
时间窗: From start of SCS trial (baseline) to 6 month after permanent implantation.
Spinal cord sensitivity to spinal cord stimulation (SCS), will be assessed using activation plots describing the relationship between SCS stimulation current (mA) and the resultant Evoked Compound Action Potential (ECAP) amplitude (µV). Change is spinal cord sensitivity (µV/mA) will be compared between the SCS trial phase and at 1 month after permanent implantation across the different medication groups.
次要结局
- Change in pain intensity measured using a 10 cm Visual Analog Scale (VAS)(From start of SCS trial (baseline) to 6 month after permanent implantation.)
- Change in pain medication intake measured via Belgian Pain Platform (BPP) and clinical verification(From start of SCS trial (baseline) to 6 month after permanent implantation.)
- Change in neurophysiological parameters such as conduction velocity (m/sec), rheobase (mA) and chronaxie (µs), measured using the Evoke system's neurophysiological assessment tools.(From start of SCS trial (baseline) to 6 month after permanent implantation.)
- Changes in sleep and activity scores(From start of SCS trial (baseline) to 6 month after permanent implantation)
研究者
Dr. Tony Van Havenbergh
Chairman, Department of Neurosurgery (NeurochirurgieGroep); Director, Antwerp Skull Base Team; Director, Brai²n
Brai²n