A Randomised Crossover Study to Investigate the Effect of Transcranial Magnetic Stimulation of the Anterior Cingulate Cortex on "Air Hunger"
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
The treatment we are studying is Transcranial Magnetic Stimulation (TMS). In TMS, an electromagnetic pulse is passed into the brain through a coil placed on the head. Previous studies have shown TMS to be capable of altering brain activity in specific areas; for example it has been used to improve mood in clinical depression. In this study we will assess if, by targeting TMS to the brain area responsible for feeling breathless, participants' breathlessness will be improved
详细描述
This protocol describes an exploratory crossover pilot study to assess whether targeted repetitive pulse Transcranial Magnetic Stimulation (TMS) i.e. targeted at the anterior cingulate cortex (ACC), affords relief of 'air hunger' in patients with breathlessness refractory to maximal medical therapy, compared to 'control' TMS directed at a remote site independent of the area of interest (within the lateral right parietal region of the brain).
12 right-handed patients suffering from refractory dyspnoea will receive pulses of targeted TMS or control TMS (crossover design), in a random order. The order will be random and use a minimisation procedure for baseline dyspnoea severity and sex. Repetitive targeted TMS (or control) pulses at 110% motor threshold at a frequency of 1Hz will be given for a 15 minute period1.
On a second, later, day the same subjects will perform the same protocol after receiving inhaled menthol or control (normal, non odorous air), in random order.
Outcomes will be assessed during the 10 minutes after targeted TMS/control TMS during which post stimulation inhibition of neural activity is expected.
研究设计
- 研究类型
- Observational
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
- •Refractory dyspnoea (persisting sensation of air hunger despite optimisation of medical treatment)
- •Histocytologically proven thoracic malignancy
- •Written informed consent
排除标准
- •Age <18 years
- •Left-handed
- •Structural brain disease (including cerebral metastasis)
- •Personal or family history of seizures
- •Implantable metallic objects e.g. a pacemaker, or other contraindication to transcranial magnetic stimulation
- •Pregnant or breast feeding
- •Previous electroconvulsive therapy (ECT)
- •Poor mobility
- •Visual impairment
- •Lack of social support / home to go to after the study treatment
- •Alcohol dependency
- •PaCO2 >6kPa at rest
- •Inability to provide informed consent