Brain STimulation for Arm Recovery After Stroke 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 454
- 试验地点
- 16
- 主要终点
- Upper extremity section of the Fugl-Meyer Assessment
研究概览
简要总结
Rationale: Every year, about 40,000 people in the Netherlands have a stroke. After the initial admission to the hospital, about 15% of stroke survivors is admitted to a rehabilitation center because of remaining disabilities. Three out of four of these patients have upper limb dysfunction, hampering activities of daily living. Upper limb function plays a critical role in the performance of most daily life activities. In our phase II trial B-STARS, continuous theta burst stimulation (cTBS) treatment led to an absolute additional recovery of upper limb function of 17%, as measured with the Action Research Arm Test (ARAT) score three months after stroke. This improvement exceeds the minimal clinically important difference of 10%. cTBS treatment also resulted in a significant improvement in measures of activities and participation (of similar magnitude) and a reduction in the mean length of stay at the rehabilitation center by 18 days.
Objective: To assess the effectiveness and cost effectiveness of cTBS treatment in promoting upper limb recovery after stroke in patients admitted to a rehabilitation center.
Study design: A phase III, multi-center, double-blind, randomized, sham-controlled, clinical trial.
Study population: 454 patients aged 18 years or older with a first-ever ischemic stroke or intracerebral hemorrhage and a unilateral arm paresis, defined by a Motricity Index between 9 and 99, in whom cTBS treatment can be started within 3 weeks after stroke onset.
Intervention: 10 daily sessions of cTBS delivered over the contralesional primary motor cortex during a period of 2 weeks, delivered immediately before regular care physical therapy of the affected upper limb.
Main study parameters/endpoints: The primary endpoint will be the score on the upper extremity section of the Fugl-Meyer assessment (FM-UE) at 90 days after stroke. Secondary endpoints will include the score on the FM-UE at one year and the scores on the Action Research Arm Test, Nine Hole Peg Test, Stroke Impact Scale, EuroQol 5 Dimensions and modified Rankin Scale at 90 days and one year after stroke
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Sham cTBS treatment is delivered with a sham TMS-coil.
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
- •Age, 18 years or older
- •First-ever unilateral ischemic stroke or intracerebral hemorrhage in a cerebral hemisphere or the brainstem;
- •Unilateral upper limb paresis with a motricity index between 9 and 99;
- •Possibility to start cTBS treatment within 21 days after stroke onset;
- •Signed informed consent.
排除标准
- •Upper limb paresis prior to stroke onset;
- •Absolute contra-indication to TMS
- •Magnetic sensitive objects implanted in the head or neck area (e.g. cochlear implants, implanted neurostimulator, pacemaker or defibrillator, metal splinters, metal fragments or metal clips);
- •History of epilepsy;
- •Other contra-indications that may potentially be harmful as determined by the treating rehabilitation physician;
- •Severe impairments that can impede study participation as determined by the treating rehabilitation physician (i.e. extreme fatigue, severe communication deficits);
- •Life expectancy shorter than one year.
研究组 & 干预措施
Active cTBS
Active cTBS delivered with an active TMS coil
干预措施: Active cTBS (Device)
Sham cTBS
Sham cTBS delivered with a sham TMS coil
干预措施: Sham cTBS (Device)
结局指标
主要结局
Upper extremity section of the Fugl-Meyer Assessment
时间窗: at 90 days post-stroke
The score ranges from 0 to 66 points with a higher score indicating better outcome
次要结局
- Upper extremity section of the Fugl-Meyer Assessment(at 12 months post-stroke)
- Action Research Arm Test(at 90 days and 12 months post-stroke)
- modified Rankin Scale(at 90 days and 12 months post-stroke)
- Hand section of Stroke Impact Scale(at 90 days and 12 months post-stroke)
- Participation section of Stroke Impact Scale(at 90 days and 12 months post-stroke)
- EuroQol-5D(at 90 days and 12 months post-stroke)
- Nine Hole Peg Test(at 90 days and 12 months post-stroke)
- Ipsilesional corticospinal excitability(within 12 hours after the 10th cTBS session)
- Upper extremity section of the Fugl-Meyer Assessment(at 12 months post-stroke)
- Action Research Arm Test(at 90 days and 12 months post-stroke)
- modified Rankin Scale(at 90 days and 12 months post-stroke)
- Hand section of Stroke Impact Scale(at 90 days and 12 months post-stroke)
- Participation section of Stroke Impact Scale(at 90 days and 12 months post-stroke)
- EuroQol-5D(at 90 days and 12 months post-stroke)
- Nine Hole Peg Test(at 90 days and 12 months post-stroke)
- Ipsilesional corticospinal excitability(within 12 hours after the 10th cTBS session)
- iMTA medical consumption questionnaire(at 6 and 12 months post-stroke)
- iMTA productivity cost questionnaire(At 6 and 12 months post-stroke)
研究者
Jord Vink
dr.
UMC Utrecht