Does Transcranial Magnetic Stimulation of the Cingulate Cortex Modulate the Perception of Dyspnoea? (TMS)
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|ClinicalTrials.gov Identifier: NCT00830921|
Recruitment Status : Terminated (Lack of patients)
First Posted : January 28, 2009
Last Update Posted : June 18, 2012
|Condition or disease||Intervention/treatment|
|Malignancy||Device: Transcranial Magnetic Stimulation|
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 :||Observational|
|Estimated Enrollment :||12 participants|
|Official Title:||A Randomised Crossover Study to Investigate the Effect of Transcranial Magnetic Stimulation of the Anterior Cingulate Cortex on "Air Hunger"|
|Study Start Date :||February 2008|
|Study Completion Date :||January 2012|
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.
Device: Transcranial Magnetic Stimulation
Transcranial magnetic stimulation (TMS) is a non-invasive method for altering brain activity in vivo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830921
|Oxford Centre for Respiratory Medicine|
|Oxford, United Kingdom, OX3 7LJ|
|Study Director:||Robert Davies||Oxford Centre For Respiratory Medicine|