Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS): A Randomized, Controlled, Multi-center, Prospective Study Evaluating Dose Reduction in ITB Patients.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Comparison of spasticity control with Synchromed II versus Prometra II
研究概览
简要总结
Comparing the efficacy of Intracthecal Baclofen dose between the Prometra II and Medtronic SynchroMed II for patients with spasticity and with current a current SyncroMed II pump needing replacement.
详细描述
The Prometra II Programmable Pump is a battery-powered, teardrop-shaped, valve-gated pump with titanium housing and triple redundancy flow controls to deliver precise amounts of medication into the intrathecal space via the separately provided Intrathecal Catheter. The Prometra Pump is remotely programmed by the Prometra Clinician Programmer to deliver medication at a constant or variable rate or to periodically deliver a drug dose at a distinct interval of time or with an immediate infusion, demand bolus.
The Prometra II Pump differs from the SynchroMed II due to the way in which it delivers medication. The Prometra pump does not have motor, gears, rollers or tubing s. Instead, the Prometra II Pump uses a pressure-driven, valve-gated delivery system. When the inlet valve opens, the pressure behind the reservoir pushes drug into the dosing chamber and the outlet valve prevents flow out of the dosing chamber or into the catheter until opened (after inlet valve closes). When the outlet valve opens, the pressure in the dosing chamber pushes the medication (2 to 3 microliters) out and then the outlet valve closes. The pump is programmed to control flow by alternately opening the inlet and outlet valves. Medication flows from the higher pressure in the reservoir to the lower pressure in the dosing chamber when the inlet valve is opened.
The only moving parts in the Prometra II Pump are the valves. The titanium fluid path is not permeable to fluids within the drug path since titanium is inert. The titanium dosing chamber and valve-gated fluid path does not allow any drug to permeate out of the chamber or drug path as is known to occur with tubing in the peristaltic pumps. This allows baclofen to be delivered more reliably in the Prometra II Pump.
As a result, the Prometra II Pump may offer several advantages over peristaltic pumps:
- The pressure-driven, valve-gated delivery mechanism has been shown to have different effects on drug dispersion in the CSF compared to peristaltic pump delivery.
- Any changes in reservoir gas pressure due to fluctuations in refill levels or environmental factors has minimal effect on Prometra II Pump dose accuracy.
- 100% titanium Prometra II Pump fluid path is not permeable to drug solutions unlike peristaltic pump tubing, etc. which can result in pump corrosion events and peristaltic rotor stalls.
- Improved dose accuracy is expected during each refill cycle with the Prometra II Pump as well as over the pump lifetime compared to peristaltic pumps.
- Improved durability and battery life are expected for the Prometra II Pump compared to peristaltic pumps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This study will employ a single-blinded approach in which study participants will not be notified of pump dosing changes. After valve-gated pump implant and dose reduction, the appropriate spasticity therapy will be provided to adequately address spasticity management in the opinion of the study investigator using standard of care processes.
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be male or female between the ages of 22 and 85 years
- •Be capable of giving informed consent (or a legally authorized representative) and completing assessments required by the study
- •Have modified Ashworth scores within 3 months prior to valve-gated pump implant
- •Have an active existing SynchroMed II intrathecal drug delivery system needing replacement
- •Existing ITB patient with spasticity of any origin.
- •Have stable drug dosage for at least 3 months prior to valve-gated pump implant
- •Be an appropriate candidate for surgery
- •Be able to comply with required study visits and assessments including English proficiency
排除标准
- •Be terminally ill and/or have a life expectancy of less than 12 months
- •Be a pregnant/lactating woman.
- •Have a systemic or local infection (contraindicated for pump implantation)
- •Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments
结局指标
主要结局
Comparison of spasticity control with Synchromed II versus Prometra II
时间窗: 3 months
To evaluate that a Baclofen dose reduction delivered through a valve-gated intrathecal drug delivery system (Prometra II) provides spasticity control no less than the baseline dose delivered through a peristaltic intrathecal drug delivery system (SynchroMed II). NOTE: In this study, a modified Ashworth scores will be prospectively collected for valve-gated pumps and will be compared to retrospectively collected modified Ashworth scores prior to peristaltic pump explant.
次要结局
- Comparison of patient report of spasm frequency with Synchromed II versus Prometra II(3 months)
研究者
Andrea Toomer
Sponsor/ Principal Investigator/ MD
Culicchia Neurological Clinic