RAD 1601: Pilot Trial of Frameless Virtual Cone Stereotactic Radiosurgical Thalamotomy for Intractable Tremor and Advanced Functional Connectivity Parcellation of the Thalamus
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall tremor reduction proportion evaluated by the Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS)
研究概览
简要总结
To determine the efficacy of frameless Virtual Cone Radiosurgical Thalamotomy for medically refractory tremor resulting from either Essential Tremor or Tremor-Dominant Parkinson's Disease with the Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) in patients who are not candidates for deep brain stimulation (DBS).
详细描述
Per the National Institute of Neurological Disorders and Stroke, tremor is an involuntary, rhythmic muscle contraction leading to shaking movements in one or more parts of the body. It is a common movement disorder that most often affects the upper extremities but can also occur in the head, vocal cords, torso, and lower extremities. Tremor may be intermittent or constant. It can be present at rest, during action, or mixed between rest and action.
Tremor can occur at any age but it is most common among middle-aged and older adults; once it occurs, it often progresses over time. This disorder shows no gender predilection. Although tremor is not life threatening, it can be severely disabling, making it difficult or even impossible to perform work and daily life tasks.
Deep parts of the brain that control movements appear to be involved in tremor development. However, most types of tremor have no actual known cause. There are some forms that appear to be inherited and run in families. There are more than 20 types of tremor. Tremor can occur on its own (such as essential tremor (ET) or be associated with other neurological disorders, such as Parkinson's disease (PD).
Tremor is a common symptom of Parkinson's disease. The classification of patients with Parkinson's disease into tremor-dominant and non-tremor subtypes is well established. The pathophysiology of tremor in patients with tremor-dominant Parkinson's disease (TDPD) may be distinct from other their other symptoms, such as bradykinesia, rigidity, and gait and balance symptoms. Importantly, tremor in PD responds less well or can even be highly resistant to dopaminergic treatment than bradykinesia and rigidity. Therefore other treatment strategies may need to be considered.
Essential Tremor (ET) is a common neurologic condition characterized by a tremor that can occur either with posture or action. In the US, there are reported to be as many as 10 million people with essential tremor. A significant subset of patients experience persistent disability and disruption on activities of daily living from tremor and require intervention.
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 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with medical refractory essential tremor or tremor-dominant Parkinson's disease that are not candidates for deep brain stimulation (DBS), either by medical/surgical co-morbidities or by choice.
- •Patients must have an ECOG status of 0, 1, or
- •Patients must be at least 18 years of age.
- •All patients must be given written informed consent.
排除标准
- •Patients who have had prior radiosurgery or therapeutic brain radiation therapy.
- •Patients with medical contra-indications to MRI imaging (e.g. pacemaker).
研究组 & 干预措施
130 Gy Radiation & Unframed Virtual Cone
130 Gy Virtual Cone Radiosurgery Unframed (Face Mask)
干预措施: Unframed Virtual Cone (Device)
结局指标
主要结局
Overall tremor reduction proportion evaluated by the Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS)
时间窗: From Baseline up to 36 months following completion of radiosurgery
The Fahn-Tolosa-Marin Tremor Rating Scale evaluation will assess the severity of the patient's tremor and measure the impact on their activities of daily living.
次要结局
- Mean of Quality of Life Scores measured by PROMIS Upper Extremity Questionnaire(From Baseline up to 36 months following completion of radiosurgery)
- Changes in resting-state functional MRI (fMRI) and diffusion tensor patterns associated with Radiosurgical thalamotomy(From Baseline up to 36 months following completion of radiosurgery)
- Patient Satisfaction Scores(3 Month Follow-Up Visit)
- Define Targeting Methods within Thalamus based on Structural and Functional Connectivity(From Baseline up to 36 months following completion of radiosurgery)
- Number of Participants with treatment-related adverse events(From Baseline up to 36 months following completion of radiosurgery)
- Mean of Quality of Life Scores measured by the Essential Tremor Rating Assessment Scale (TETRAS)(From Baseline up to 36 months following completion of radiosurgery)
- Mean of Quality of Life Scores measured by SF-36 questionnaire(From Baseline up to 36 months following completion of radiosurgery)
研究者
John Fiveash, MD
Principal Investigator
University of Alabama at Birmingham
