NCT02089464已完成不适用
Pivotal Phase III, Prospective, Multicenter, Double Blinded, Randomized, Sham Controlled Trial to Determine the Therapeutic Effects of Navigation Guided 1 Hz rTMS Administered to the Contralesional Hemisphere as Adjuvant to Task Oriented Rehabilitation in Patients With Ischemic or Hemorrhagic Stroke
Nexstim Ltd23 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2014年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 23
- 主要终点
- Upper Extremity Fugl-Meyer Score
研究概览
简要总结
A pivotal, prospective, multi-center, randomized, controlled, double-blinded study combining active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized task oriented rehabilitation will be conducted in patients with post-stroke motor impairment. The therapy will be provided for 6 weeks and primary outcome assessed 6 months later.
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, Investigator, Outcomes Assessor)
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
- •≥ 18 years of age
- •An ischemic or hemorrhagic stroke suffered 3-12 months prior to the study;
- •no other known brain abnormalities by history;
- •A one-sided stroke resulting in upper extremity paresis
- •A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb
排除标准
- •Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump;
- •Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening.
- •Active alcohol abuse, illicit drug use or drug abuse or significant mental illness
- •Patients suffering from depression as measured by a score of >10 on the Patient Health Questionnaire (PHQ9). For clarity, patients diagnosed with depression which is controlled with stable anti-depressive medication and in whom PHQ9 is <10 are eligible to participate in the trial.
- •History of epilepsy, defined as at least two unprovoked seizures occurring greater than 24 hours apart or diagnosis of an epilepsy syndrome, OR a seizure within the last 12 months.
- •Any condition that would prevent the subject from giving voluntary informed consent;
- •An implanted brain stimulator;
- •Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body;
- •Enrolled or plans to enroll in an interventional trial during this study;
- •Scalp wounds or infections;
- •Claustrophobia precluding MRI;
- •A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact;
- •Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in either elbow flexors, wrist flexors or finger flexors of the affected limb;i
- •previous stroke with residual deficits (TIAs not a reason for exclusion);
- •premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology;
- •a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition,
- •confirmed or suspected lower-limb fracture preventing mobilization,
- •patients requiring palliative care
- •patients planning to undergo any other occupational therapy during the 6 week active treatment period of the trial (see section 5.2 for study schedule) than what is provided in the study
- •A recent injection of botulinium toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up.
- •A recent injection of phenol to the affected upper limb in the last 6 months, or the need of an injection of phenol anytime during the study period and follow up.
- •Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale.
- •Severe sensory deficits as measured by a score of 2 on item 8 of the NIH stroke scale.
- •Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale.
- •Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale.
- •Patients unable to comprehend or follow verbal commands
- •Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition
- •A Mini mental status exam (MMSE) <25.
结局指标
主要结局
Upper Extremity Fugl-Meyer Score
时间窗: Baseline - 6 months post-treatment
Number of Participants with Improvement in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-treatment equal or exceeding the Minimal Clinically Important Difference (MCID) of 5 points (MCID).
次要结局
- Quality of Life Assessment: EuroQol EQ-5D Scale(Baseline - 6 months post-treatment)
- Arm-Research Action Test (ARAT)(Baseline - 6 months post-treatment)
- Chedoke-McMaster Stroke Assessment (CMSA)(Baseline - 6 months post-treatment)
- Wolf Motor Function Test(Baseline - 6 months post-treatment)
- NIH Stroke Scale (NIHSS)(Baseline - 6 months post-treatment)
- Stroke Impact Scale (SIS)(Baseline - 6 months post-treatment)
- Patient Health Questionnaire (PHQ9)(Baseline - 6 months post-treatment)
研究者
研究点 (23)
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