Feasibility of Navigated Transcranial Magnetic Stimulation (nTMS) of Patients Treated With Stereotactic Radiosurgery for Brain Metastases in the Motor Cortex: A Comprehensive Cross-Sectional Assessment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Economic feasibility of nTMS
研究概览
简要总结
This trial studies how well nTMS works in planning for stereotactic radiosurgery in patients with brain metastases in the motor cortex. Stereotactic radiosurgery is a type of radiation therapy that delivers high doses of radiation, which can sometimes lead to damage occurring to the brain and surrounding areas. The motor cortex (the part of the nervous system that controls muscle movement), however, currently has no radiation dose limit. nTMS is a non-invasive tool that uses sensors on a patient's muscle to trace the location in their brain that controls that muscle and is currently used by doctors to decide where to operate so as not to damage the motor nerves. nTMS may effectively help plan radiation treatment using SRS and help doctors decide on how much radiation can be used on motor nerves.
详细描述
PRIMARY OBJECTIVES:
I. To determine if the use of navigated transcranial magnetic stimulation (nTMS) in the radiation oncology clinic is feasible.
SECONDARY OBJECTIVES:
I. To investigate the relationship of stereotactic radiosurgery (SRS) dosimetry and lesion involvement in the motor tracts identified using nTMS and the presence or absence of motor deficits evaluated by objective and subjective measures (Manual Ability Measure [MAM]-20, Euroqol [EQ]-5 Dimensional [D]-5 Level [L], and MD Anderson Symptom Inventory [MDASI]-Brain Tumor [BT] questionnaires).
II. To determine if nTMS of contralateral motor tracts provides a viable internal control, considering handedness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adult patients with brain metastases located in or near the motor cortex who have previously received SRS to that lesion within the prior 3-18 months
- •Patients must be able to participate in nTMS of bilateral motor cortices
- •Patients must be able to participate in an electromyography (EMG)
- •Patient's must have utilized magnetic resonance imaging (MRI) for their previous SRS treatment planning
- •Patient must be able to complete the Functional and Quality of Life questionnaires in English
排除标准
- •Significant cognitive or psychiatric symptoms that prevent the ability to complete a physical exam, questionnaires, or participate in nTMS or EMG
- •Poor performance status Karnofsky performance score (KPS < 60) that prevents the ability to participate in a physical exam, nTMS, or EMG. Patients will not be excluded if they are not able to complete the exploratory EEG analysis
- •Patients receiving any prior treatment that might impact their cognitive, psychiatric, or motor cortex function
研究组 & 干预措施
Diagnostic (nTMS, sensory testing)
Patients undergo nTMS over 1 hour. Patients also perform 4 tasks that test grip and pinch strength, and the ability to use and feel with their hands for 1 hour.
干预措施: Hand Function Test (Behavioral)
Diagnostic (nTMS, sensory testing)
Patients undergo nTMS over 1 hour. Patients also perform 4 tasks that test grip and pinch strength, and the ability to use and feel with their hands for 1 hour.
干预措施: Navigated Transcranial Magnetic Stimulation (Procedure)
Diagnostic (nTMS, sensory testing)
Patients undergo nTMS over 1 hour. Patients also perform 4 tasks that test grip and pinch strength, and the ability to use and feel with their hands for 1 hour.
干预措施: Quality-of-Life Assessment (Other)
Diagnostic (nTMS, sensory testing)
Patients undergo nTMS over 1 hour. Patients also perform 4 tasks that test grip and pinch strength, and the ability to use and feel with their hands for 1 hour.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Economic feasibility of nTMS
时间窗: Up to 1 year
Will be determined to be economically feasible if there are no additional costs to the patients and department, other than those outlined in the proposed budget.
Identification of the motor cortex by addition of nTMS
时间窗: Up to 1 year
The treating radiation oncologist will determine if the use of nTMS provides additional information over the standard atlas-based definition of the motor region if they state that they would have made adjustments to their treatment volume of the tumor based on the new nTMS data provided.
Operational feasibility of navigated transcranial magnetic stimulation (nTMS)
时间窗: Up to 1 year
Will be determined to be operationally feasible on a patient if the images and data obtained from nTMS for the patient provide useful information to the radiation oncologist and if the radiation oncologist determines that this additional information would improve patient care. Will deem the use of nTMS to be operationally feasible overall if it is deemed operationally feasible on an underlying proportion of at least 90% potentially consented patients. Will calculate the proportions of operational and technical feasibility of the use of nTMS and their 80% confidence intervals (CIs). If the observed proportions are greater than or equal to 82%, the use of nTMS to be operationally and technically will be deemed feasible.
Technical feasibility of nTMS
时间窗: Up to 1 year
Will be determined to be technically feasible on a patient if the procedure of nTMS is able to be performed on the patient, resulting in mapped motor cortex data. If the patient is not able to complete the procedure for any reason, that patient's nTMS treatment will not be technically feasible. Will deem the use of nTMS to be technically feasible overall if it is deemed technically feasible on an underlying proportion of at least 90% potentially consented patients. Will calculate the proportions of operational and technical feasibility of the use of nTMS and their 80% CIs. If the observed proportions are greater than or equal to 82%, the use of nTMS to be operationally and technically will be deemed feasible.
次要结局
- Presence or absence of motor deficits(Up to 1 year)
- Stereotactic radiosurgery (SRS) dosimetry and lesion involvement in the motor tracts(Up to 1 year)
- Development of a clinical trial that will limit radiation dose to brain metastases(Up to 1 year)
- Utility of electroencephalography (EEG)(Up to 1 year)
- Production of viable internal control by contralateral motor tract, accounting for handedness(Up to 1 year)