Brain Stimulation For Cancer Smokers
Repetitive Transcranial Magnetic Stimulation For Smoking Cessation In Cancer Patients
研究概览
详细说明
Specific aims: Smoking cessation and relapse prevention represent and important opportunity to improve cancer survival rates , reduce the risk of cancer treatment complication, and improve the quality of life of patients with and survivors of cancer . Previous studies showed that repetitive TMS (rTMS) reduced cue craving to smoking and treat nicotine dependent smokers. Recently one study completed by our team demonstrated that 10 sessions of rTMS over the left dorsolateral prefrontal cortex (DLPFC) reduced cigarette consumption and cue craving, and also increased quitting rate on target quit date in nicotine dependent smokers. Thus, we propose conducting a controlled, double-blind trial comparing the effect of treatments of active rTMS and sham rTMS on cigarette abstinence days, cigarette consumption and smoking craving during a 7-days of quit attempt period in 20 nicotine-dependent patients with cancer. Specific aims are: Aim 1: Assess a feasibility of the rTMS for smoking cessation in cancer patients. Aim 2: Obtain preliminary estimates of whether one-week active rTMS of left DLPFC tends to be more efficacious than sham rTMS during a 7-days of quit attempt laboratory model period increasing abstinence days, and also decreasing cigarette consumption and cue-elicited craving in cancer patients with smoking.
1.1. Primary objective To assess a feasibility of the rTMS for smoking cessation in cancer patients: The primary feasibility measures are : whether or not we can enroll 20 cancer patients with smoking within 12 months? 1.2 Secondary objectives
(1) Study attrition. How many subjects can complete 7-day quit attempt during rTMS treatment? How many subjects will complete one-month follow-up? (2) To obtain preliminary estimates of whether one-week active rTMS of left DLPFC tends to be more efficacious than sham rTMS during a 7-days of quit attempt laboratory model period increasing abstinence days, and also decreasing cigarette consumption and cue-elicited craving in cancer patients with smoking.
1.3 Exploratory objectives Self-reported number of cigarettes smoked per day, The brief questionnaire of smoking urges (QSU - Brief), visual analog scale for craving and side effect will be measured pre and post each rTMS session. Other assessment, Carbon Monoxide, Fagerstrom Test for Nicotine Dependence (FTND), and Minnesota Nicotine withdrawing Scale (MNWS) will be completed at baseline and the last TMS. Quitting attempt will verify daily CO < 5 ppm. FTND, Feasibility metrics will also be tracked, including numbers of complete TMS sessions and dropout rate.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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South Carolina
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Charleston、South Carolina、美国、29425
- Medical University of South Carolina
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
1. Completed cancer treatment (e.g. surgery, chemotherapy and radiation) > 6 months Patients with current endocrine therapy will be included for the study.
2. Have been diagnosed with noninvasive or invasive (Stage 1, 2, or 3A) breast cancer or prostate cancer.
3. Smoke 5 or more cigarettes per day and have a carbon monoxide (CO) level > 5 ppm indicative of recent smoking.
4. Not have received substance abuse treatment within the previous 30 days. 5. Meet criteria for low to moderate nicotine dependence as determined by FTND ≥1.
6. Be willing to provide informed consent. 7. Be able to comply with protocol requirements and likely to complete all study procedures.
8. Is willing to consider trying to quit smoking. 9. Have no active cardiac, neurologic, or psychiatric illness. 10. 0.5-10 years post diagnosis of cancer at the time enrollment.
Exclusion Criteria:
- Current dependence, defined by Diagnostic and Statistical manual of Mental Disorders (DSM)-V criteria, on any psychoactive substances other than nicotine or caffeine.
- Contraindication to rTMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for > 15 minutes, implanted electronic device, metal in the head, or pregnancy).
- History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.
- History of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Active rTMS treatment
Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment.
Stimulation frequency for all active subjects: 10 Hertz - Pulse train duration (on time) 5 seconds, Inter-train interval (off time) 10 seconds (15 second cycle time), Power (intensity) level 100% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.
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Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression.
The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
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假比较器：Sham rTMS treatment
Transcranial Magnetic Stimulation Clinical Research System -sham TMS will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex.
The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead.
Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
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Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression.
The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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The Number of Enrollment
大体时间：12 months
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How many cancer patients with smoking can be enrolled in 12 months?
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Number of Abstinence Days.
大体时间：5 days
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Total number of smoke-free days during a day quit attempt.
Self-reported abstinence during the day quit attempt will be assessed via timeline.
The maximum number of consecutive days of abstinence will be recorded.
Participants who does not report at least one 24-hour period of abstinence will be recorded as "0" days abstinent.
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5 days
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Effect of rTMS on Cigarette Consumption
大体时间：5 days
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the change of self-reported number of cigarettes smoked per day
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5 days
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Effect of rTMS on Cue Craving to Smoke Cigarette
大体时间：5 days
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Brief questionnaire of smoking urges - brief (QSU - Brief) is used to assess smoking urges.
Ten questions are included in the test.
Range of scales is 1-7 score for each item.
The cue craving scales include 10 items.
The range of the total score is 10- 70 score.
The maximum number means the highest craving that is the worst outcome.
The minimum number is the least craving for cigarettes that is the best outcome.
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5 days
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Effect of rTMS on Cue Craving to Smoke Cigarette
大体时间：5 days
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The change of visual analog scale (VAS).
The VAS has 1-7 score.
The minimum is 1 which means the best result.
The maximum value of 7 is the worst outcome.
The VAS was measured during 5 treatment sessions.
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5 days
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Adverse Events
大体时间：5 days
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Side effect will be measured pre and post each rTMS session.
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5 days
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Study Attrition Rate
大体时间：12 months
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How many subjects completed treatment and a 30 days follow-up.
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12 months
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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