Feasibility of Navigated Repetitive Transcranial Magnetic Stimulation (nrTMS) to Augment the Effects of Motor Rehabilitation in Brain Tumor Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Intervention adherence
研究概览
简要总结
This trial studies how well navigated repetitive transcranial magnetic stimulation works in improving motor rehabilitation in participants with brain tumors. Navigated repetitive transcranial magnetic stimulation may help improve patients' lost motor function after surgery.
详细描述
PRIMARY OBJECTIVES:
I. Determine feasibility of conducting 10 sessions of navigated repetitive transcranial magnetic stimulation (nrTMS) during the post-surgical rehabilitation time period.
EXPLORATORY OBJECTIVES:
I. Explore the effects of the nrTMS training program on motor recovery. II. Explore changes in cortical activity: electroencephalographic (EEG) activity including event-related potentials (ERPs) and motor evoked potentials (MEPs) will be assessed from baseline to end of treatment (EOT).
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with brain tumors associated with the motor cortex
- •Understand and read English, sign a written informed consent, and be willing to follow protocol requirements
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Motor impairment must be related to the surgical procedure or the tumor itself (in the opinion of the treating physician)
- •Patients who are within 7 days of brain tumor resection associated with the motor cortex
- •Eligibility for the nrTMS treatment will be based on motor ability and will be determined postoperatively by the surgeon
排除标准
- •Patients who are taking any antipsychotic medications
- •Patients who have ever been diagnosed with bipolar disorder or schizophrenia
- •Patients with a history of stroke
研究组 & 干预措施
Supportive care (nrTMS)
Between 1-7 days after standard of care surgery, participants undergo 10 nrTMS sessions over 30 minutes each over 3 weeks.
干预措施: Questionnaire Administration (Other)
Supportive care (nrTMS)
Between 1-7 days after standard of care surgery, participants undergo 10 nrTMS sessions over 30 minutes each over 3 weeks.
干预措施: Transcranial Magnetic Stimulation (Procedure)
结局指标
主要结局
Intervention adherence
时间窗: Up to 3 months
Will be defined as a participant as completing at least 70% of the (i.e., seven out of 10) treatment sessions. Feasibility will be defined as: 1) at least 70% of the participants adhere to the treatment. Patients will have to finish all 10 trains in each navigated repetitive transcranial magnetic stimulation (nrTMS) run in order to be considered complete; 2) at least 37% of the eligible patients (at a rate of approximately 3/8 per month) enroll in the study.
次要结局
未报告次要终点