Does Transcranial Magnetic Stimulation of the Cingulate Cortex Modulate the Perception of Dyspnoea? (TMS)
|First Received Date ICMJE||January 27, 2009|
|Last Updated Date||June 15, 2012|
|Start Date ICMJE||February 2008|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00830921 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Does Transcranial Magnetic Stimulation of the Cingulate Cortex Modulate the Perception of Dyspnoea?|
|Official Title ICMJE||A Randomised Crossover Study to Investigate the Effect of Transcranial Magnetic Stimulation of the Anterior Cingulate Cortex on "Air Hunger"|
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
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Probability Sample|
Patients attending out-patient clinic
|Intervention ICMJE||Device: Transcranial Magnetic Stimulation
Transcranial magnetic stimulation (TMS) is a non-invasive method for altering brain activity in vivo.
|Study Group/Cohort (s)||1
Patients will be identified from the Oxford Pleural Clinic and from referrals within the multi-disciplinary team including palliative care and oncology services.
Screening criteria are based on normal practice and consecutive eligible patients will be offered trial entry. The principal investigator or a nominated member of staff will approach participants who fulfil the criteria for inclusion in the study. Screening logs will be kept.
Intervention: Device: Transcranial Magnetic Stimulation
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Estimated Enrollment ICMJE||12|
|Completion Date||January 2012|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United Kingdom|
|NCT Number ICMJE||NCT00830921|
|Other Study ID Numbers ICMJE||07/Q1607/48|
|Has Data Monitoring Committee||No|
|Responsible Party||University of Oxford|
|Study Sponsor ICMJE||University of Oxford|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Oxford|
|Verification Date||June 2012|
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