A Single Center, Open, Non-controlled Pilot Investigation to Evaluate FLowOx2.0™ for Experimental Treatment of Spasticity With Concomitant Pain in Multiple Sclerosis, Using Intermittent Negative Pressure Affecting Arteriovenous Reflex
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Self-Reported Spasticity, using Numerical Rating Scale:
研究概览
简要总结
This is a descriptive, prospective, non-controlled clinical investigation to be conducted on approximately 10 enrolled subjects at one site at Haukeland University Hospital in Bergen, Norway. The target subjects are male or female, 18-70 years, diagnosed with MS according to revised McDonald criteria (9) with spasticity and pain associated with the spasticity. Spasticity is evaluated based on self-reported spasticity using the numerical rating scale (NRS) which describes the average score of spasticity over the last 24 hours at >4 (where the scale scores spasticity from 0-10, where 0 is no spasticity, and 10 is worst possible spasticity), - combined with pain in the lower extremities last 24 hours. The pilot investigation is done to evaluate if FlowOx2.0™ can be used to treat spasticity with concomitant pain in patients with multiple sclerosis, using intermittent negative pressure affecting arteriovenous reflex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnose MS according to revised McDonald criteria
- •Give written informed consent.
- •Have an age between 18-70 years.
- •Have stable disease without attack or progression of loss of function in the last three months.
- •Have self-reported spasticity, scored using the numeric rating scale (NRS) which describes the average score of spasticity over the last 24 hours, at ≥ 4 (where the scale scores spasticity from 0-10, where 0 is no spasticity, and 10 is worst possible spasticity), - combined with pain in the lower extremities last 24 hours
- •Have tried standard treatment for spasticity and pain without achieving a satisfactory effect.
- •Stable and unchanged treatment of spasticity and pain the last month
- •Stable and unchanged disease-modulating treatment for MS last 6 months.
- •Function level measured by the Expanded Disability Status Scale (EDSS) 2.0-6.5
- •Can self-manage study equipment.
排除标准
- •Have spasticity due to a disease other than MS.
- •Pregnancy or plan a pregnancy within the upcoming study period of 6 months.
- •Have an ongoing infection.
- •Have received botulinum toxin injection for spasticity within the last 4 months.
- •Have symptoms or illness that make it difficult to participate in the study.
- •Having planned surgery or other treatment within the coming study period of 6 months makes it difficult to participate in the study.
- •Have functional scores outside inclusion criteria measured by EDSS 2.0-6.5
- •Have had disease activity beyond requirements for stable disease as described in inclusion criteria
- •Have changed drug treatment beyond requirements for stable treatment as described in inclusion criteria.
结局指标
主要结局
Self-Reported Spasticity, using Numerical Rating Scale:
时间窗: 4 weeks
The unabbreviated scale title: Numerical Rating Scale The minimum and maximum values: 0, 10 Higher scores mean a worse outcome. To evaluate change in self-reported spasticity using the numerical rating scale (NRS) over the last 24 hours after daily 1-hour self-treatment with FlowOx from baseline to week 4
次要结局
- Spasticity - modified Ashworth Scale(4 weeks, 3 months and 6 months)
- T25-FW(4 weeks, 3 months, 6 months)
- SDMT(4 weeks, 3 months, 6 months)
- Self-reported pain using Numerical Rating Scale(4 weeks, 3 months and 6 months)
- Expanded Disability Status Scale(4 weeks, 3 months, 6 months)
- Self-reported sleep (NRS)(4 weeks, 3 months, 6 months)
- Change in medication(4 weeks, 3 months and 6 monhts)
- Hospital Anxiety and Depression Scale(4 weeks, 3 months, 6 months)
- Compliance(4 weeks, 3 months, 6 months)
- Safety- Incidence of device related adverse and serious adverse events(4 weeks, 3 months, 6 months)
- Desire to continue treatment(4 weeks)
- Self-Reported Spasticity, using Numerical Rating Scale(3 months, 6 months)
- Fatigue Scale for Motor and Cognitive Functions(4 weeks, 3 months, 6 months)
- Multiple Sclerosis Impact Scale (MSIS-29)(4 weeks, 3 months, 6 months)