A Randomised Crossover Study to Investigate the Effect of Transcranial Magnetic Stimulation of the Anterior Cingulate Cortex on "Air Hunger"
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.
Observational
N/A
Robert Davies
Study Director
Oxford Centre For Respiratory Medicine
United Kingdom: Research Ethics Committee
07/Q1607/48
NCT00830921
February 2008
January 2012
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