Repetitive Intermittent Accelerated Theta-burst Transcranial Stimulation(iTBS) as a Potential Intervention for Chemotherapy Induced Cognitive Deficits (CICD)- a Pilot Clinical Trial to Explore Feasibility and Efficacy
概览
- 阶段
- 不适用
- 干预措施
- Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS)
- 疾病 / 适应症
- Cancer
- 发起方
- Sneha Phadke
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Mean changes in executive cognitive function between pre and post application of iTBS treatment protocol
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
This project is aimed at the discovery of neuro-modulation techniques that may alleviate chemotherapy induced cognitive deficits (CICD), especially in executive (higher-order) cognitive function (EF).
详细描述
The specific aim for this study is to use magnetic resonance spectroscopy (MRS), self-report, and neuropsychological testing to identify changes in brain metabolite concentrations/ratios and changes in EF deficits associated with chemotherapy, before and after accelerated theta-burst transcranial stimulation (iTBS). The secondary aim is to assess for any association of changes in executive function with brain metabolite concentrations.
研究者
Sneha Phadke
Clinical Associate Professor
University of Iowa
入排标准
入选标准
- •Women or men with a history of non-metastatic cancer who have completed definitive curative cancer therapy
- •Received cytotoxic chemotherapy as a part of their therapy for cancer and at least one month has passed since the final cytotoxic chemotherapy treatment
- •≥ 18 years of age at time of cancer diagnosis and receipt of chemotherapy
- •Patients must report subjective symptoms of "chemo-brain" (memory loss, difficulty with concentration, word-finding difficulties) with a FACT-Cog perceived cognitive impairment score \< 60
- •Ability to sign informed consent and comply with study procedures
排除标准
- •Patients with a recurrence of cancer or those with current metastatic disease
- •Patients with a history or current diagnosis of brain metastasis
- •Patients with a history or current diagnosis of a primary brain tumor
- •Patients with a history of brain surgery or brain radiation
- •Patients receiving maintenance systemic therapy for cancer, other than endocrine therapy
- •Patients who cannot produce or request adequate medical record documentation to ensure they meet inclusion and exclusion criteria
- •Women who are currently pregnant
- •History of childhood cancer or receipt of chemotherapy in childhood (\<age 18). Developmental insult to the PFC, can be associated with long-term, durable and sometime debilitating cognitive deficits. Hence, we avoid any cognitive confounds that maybe related to this issue.
- •Patients with a weight over 250 lbs., as these patients would not fit in the MRI scanner used in the protocol
- •Patients who require benzodiazepines for MRI due to claustrophobic anxiety
研究组 & 干预措施
Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) or sham
Patients will participate in the prospective longitudinal research protocol over a period of 1.5 months. Treatment will include 8 visits of either accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) or iTBS sham stimulation. Patients will be informed that iTBS sham stimulations will be part of the protocol (but will be blind to when treatment/sham will be administered).
干预措施: Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS)
结局指标
主要结局
Mean changes in executive cognitive function between pre and post application of iTBS treatment protocol
时间窗: 1.5 months
Executive cognitive function will be quantified using technician administered Color Word Interference Test, Category Fluency, Tower of Hanoi, Card Sort and Strategy Application Task (Shallice \&Burgess) tests, and the self-report Functional Assessment of Cancer Therapy - Cognitive Scale (FACT-COG) (Dyk et al.). Executive Function (EF) is measured by utilizing standardized test scores adapted from the Delis-Kaplan Executive Function Scales (D-KEFS battery) (Homack et al.). FACT-COG, Category Fluency and Strategy Application Task use raw scores. All EF measures used in this battery form a part of a normative database created and maintained by the principle investigator of this study. An overall score of EF is computed by averaging the Z scores of each test. Higher score on each test represents better performance.
Mean changes in brain metabolite concentrations between pre and post application of iTBS treatment protocol
时间窗: 1.5 months
Proton Magnetic Resonance Spectroscopy will be used to quantify brain metabolite concentrations in parts per million. Brain metabolites under evaluation include: glutamine, glutamate, N-acetyl aspartate, choline, and creatine.