Improving Therapeutic Outcomes in the Tongue Carcinoma Patient: Assessment of Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- To utilize fMRI to characterize adaptation to alterations in tongue morphology & function following either surgical therapy, or radiation/chemotherapy to tongue in patients undergoing treatment of malignancies involving the tongue.
研究概览
简要总结
The purpose of this study is to see how the brain re-learns to control the tongue in speaking and swallowing when either portions of the tongue have been removed, or when the tongue has been treated with radiation, in order to treat cancer. We hope the results of this study will help us to improve healing for patients who are being treated for cancer of the tongue.
When patients with cancer of the tongue are treated by removing parts of the tongue (surgery) or by destroying the cancer with radiation to the tongue, they have significant difficulty speaking and swallowing after such treatments. At this time, patients who have been treated for cancer of the tongue re-learn speaking and swallowing through exercises taught by a speech pathologist.
What is needed is information on how the brain re-learns to control speaking and swallowing so that we can help these patients re-learn faster after their treatments.
详细描述
The purpose of this investigation is to determine cortical mechanisms of adaptation to surgical or radiation treatment to the tongue. This study will use a non-invasive imaging technique, Functional Magnetic Resonance Imaging (fMRI), to investigate cortical responses to partial glossectomy or radiation therapy for treatment of a tongue malignancy. Patients with Stage I-IV (AJCC) malignancies of the tongue who are treated with surgery and or radiation therapy will be imaged using fMRI pre-operatively and at approximately six months postoperatively.
Patterns of brain activity from the fMRI studies will be compared with matched healthy control subjects. The results of this investigation will provide needed information on both central and peripheral mechanisms of adaptation.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for the tongue carcinoma patients:
- •Primary malignancy of the oral or base of tongue, Stage I-IV of AJCC staging system, planned for surgical or radiation therapy.
- •Inclusion criteria for the healthy subjects:
- •Healthy adult subjects between the ages of 21-75 years.
排除标准
- •Exclusion criteria for the tongue carcinoma patients include the following:
- •History of significant psychiatric condition (e.g. schizophrenia, obsessive-compulsive disorder, significant dementia),
- •History of the following neurological conditions: CVA, seizure disorders, demyelinating conditions, systemic neuromuscular disorders, cerebral palsy, Alzheimer's disease.
- •History of previous moderate to severe traumatic brain injury.
- •History of significant cardiovascular, respiratory, gastrointestinal or renal disease (e.g.myocardial infarction within the previous 12 months, significant vaso-occlusive disease,severe or advanced asthma, COPD, emphysema, gastroesophageal reflux disease, or renal compromise)
- •History of achalasia
- •History of other neoplasms involving the brain, head and neck, or gastrointestinal system.
- •History of dysphagia, odynophagia, or aphasia unrelated to present illness.
- •History of significant claustrophobic reactions.
- •Standard contraindications to MR examinations (e.g. implanted stimulators).
- •Exclusion criteria for the healthy subjects includes the all of the conditions listed for the tongue:
- •Carcinoma patients and additionally includes history of significant surgery or previous radiation therapy to the head and neck
- •Previous history of dysphagia, odynophagia, aphasia, pregnancy,and standard contraindications to MR examinations.
结局指标
主要结局
To utilize fMRI to characterize adaptation to alterations in tongue morphology & function following either surgical therapy, or radiation/chemotherapy to tongue in patients undergoing treatment of malignancies involving the tongue.
时间窗: 7 years
次要结局
- Determine relationship between mechanisms of adaptation at level of central nervous system to alterations in function in the tongue.(7 years)
- Determine changes in cortical activity in representation of tongue movement that occur pre and post-treatment.(7 years)
- Determine the central neural response to direct peripheral rehabilitation strategies.(conclusion of study)