NCT04279912Unknown不适用
A Feasibility and Safety Clinical Trial of the Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Composite safety outcome of MRgFUS thalamotomy
研究概览
简要总结
This study will be a single-centre, prospective, single-arm, open-label pilot trial assessing the feasibility and safety of unilateral MR-guided focused ultrasound (MRgFUS) thalamotomy for refractory hand tremor in up to 12 patients with multiple sclerosis (relapsing-remitting, primary progressive or secondary progressive MS). This study will be conducted at the Focused Ultrasound Centre of Excellence and MS Clinic located at Sunnybrook Health Sciences Centre/ University of Toronto. Patients with stable MS and refractory hand tremor providing informed consent will receive MRgFUS thermal ablation of the Vim thalamus contralateral to the most affected side of the body (frequently this will be the dominant hand).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female aged 18-80 years
- •Willing and able to give consent and attend all study visits
- •A confirmed diagnosis of medication-refractory, MS-related hand tremor
- •No clinical evidence of relapse over 12 months or more before enrollment
- •No MRI activity over 3 months or more before enrollment
- •Presence of disabling postural or kinetic tremor
- •Unsatisfactory tremor response to adequate trials of at least two medications
- •Able to communicate sensations during the treatment
- •Stable doses of all medications for 30 days prior to and during study
排除标准
- •Severe cerebellar dysfunction measured by Scale for the Assessment and Rating of Ataxia (>35 out of 40)
- •Severe weakness or sensory loss in arm contralateral to the side of the brain considered for MRgFUS
- •Evidence of a superimposed or atypical movement disorder
- •Unstable cardiac status such as angina pectoris, congestive heart failure, etc.
- •Severe hypertension
- •Patients with standard contraindications for MR imaging
- •History of abnormal bleeding and/or coagulopathy
- •Ischemic or hemorrhagic stroke within 6 months
- •Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema)
- •Untreated, uncontrolled sleep apnea
- •Active or suspected acute or chronic uncontrolled infection
- •Receiving anticoagulant or antiplatelet therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage within one month of MRgFUS surgery
- •Not able or willing to tolerate the required prolonged stationary supine position during treatment
- •Participating or have participated in another clinical trial in the last 30 days
- •Unable to communicate with the investigator and staff
- •Presence of neurodegenerative disease or significant cognitive impairment
- •Presence of significant cognitive impairment (≤24 on MMSE)
- •Uncontrolled major psychiatric disorder or suicidal ideation
- •Risk factors for intraoperative or postoperative bleeding or documented coagulopathy
- •Presence of brain tumours
- •Any illness that in the investigator's opinion preclude participation in this study
- •Pregnancy or lactation
- •Legal incapacity or limited legal capacity
- •Deep Brain Stimulation or a prior stereotactic ablation of the basal ganglia
- •A history of seizures within the past year
结局指标
主要结局
Composite safety outcome of MRgFUS thalamotomy
时间窗: 90 days
Composite outcome of detectable Vim lesion on MRI scan; AND lack of new-onset or worsening of contralateral upper limb sensory loss or weakness
次要结局
- Changes from baseline in the EDSS (Expanded Disability Status Scale) scores(30 and 90 days)
- Changes from baseline in QUEST (Quality of Life in Essential Tremor Questionnaire) scores(30 and 90 days)
- Change from baseline in the CRST (Clinical Rating Scale for Tremors)(30 and 90 days)
- Changes from baseline in the SARA (Scale for Assessment and Rating of Ataxia) scores(30 and 90 days)
- Composite safety outcome of MRgFUS thalamotomy(30 days)
- Incidence and severity of adverse events related to MRgFUS thalamotomy(1, 7, 30, 90 and 120 days)
- Changes from baseline in the speech intelligibility (percentage of intelligible words recorded during standardized passage reading)(30 and 90 days)
- Incidence and severity of adverse events related to MS disease relapse or progression(30 and 90 days)
研究者
Dr. Nir Lipsman
Neurosurgeon, Principal Investigator, Assistant Professor
Sunnybrook Health Sciences Centre
研究点 (2)
Loading locations...
相似试验
终止
不适用
LymphoPilot Test for Limb LymphedemaLymphedema, SecondaryLymphedema of Upper LimbLymphedema ArmLymphedema of LegLymphedema, Lower LimbNCT04858230Lymphatica Medtech SA12
已完成
不适用
SIRONA Trial Heart Failure NYHA Class IIIHeart Failure NYHA Class IIINCT03375710Endotronix, Inc.15
Unknown
1 期
Endovascular Stenting Treatment for Patients With Internal Jugular Vein StenosisStent StenosisIntracranial HypertensionHeadachePapilledemaVisual ImpairmentTinnitusNCT03373292Capital Medical University60
Unknown
早期 1 期
Novel Light Delivery Methods for Lung Cancer Photodynamic Therapy - A Pilot StudyNon-small Cell Lung Cancer (NSCLC)Lung MetastasisNCT04753918Taoyuan General Hospital3
已完成
1 期
A Safety and Efficacy Study Evaluating CS-101 in Subjects With β-Thalassemia MajorBeta-Thalassemia MajorNCT06291961CorrectSequence Therapeutics Co., Ltd9