Ignite Creation Date:
2024-05-05 @ 9:12 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00830921
Status:
TERMINATED
Last Update Posted:
2012-06-18
First Post:
2009-01-27
Brief Title:
Does Transcranial Magnetic Stimulation of the Cingulate Cortex Modulate the Perception of Dyspnoea
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
A Randomised Crossover Study to Investigate the Effect of Transcranial Magnetic Stimulation of the Anterior Cingulate Cortex on Air Hunger
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TMS
Brief Summary:
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
Detailed Description:
This protocol describes an exploratory crossover pilot study to assess whether targeted repetitive pulse Transcranial Magnetic Stimulation TMS ie 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 TMScontrol TMS during which post stimulation inhibition of neural activity is expected
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 TMScontrol TMS during which post stimulation inhibition of neural activity is expected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None