Does Transcranial Magnetic Stimulation of the Cingulate Cortex Modulate the Perception of Dyspnoea? (TMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00830921
Recruitment Status : Terminated (Lack of patients)
First Posted : January 28, 2009
Last Update Posted : June 18, 2012
Information provided by (Responsible Party):
University of Oxford

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

Condition or disease Intervention/treatment
Malignancy Device: Transcranial Magnetic Stimulation

Detailed Description:

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
Actual Study Completion Date : January 2012

Group/Cohort Intervention/treatment

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients attending out-patient clinic

Inclusion Criteria:

  1. Refractory dyspnoea (persisting sensation of air hunger despite optimisation of medical treatment)
  2. Histocytologically proven thoracic malignancy
  3. Written informed consent

Exclusion Criteria:

  1. Age <18 years
  2. Left-handed
  3. Structural brain disease (including cerebral metastasis)
  4. Personal or family history of seizures
  5. Implantable metallic objects e.g. a pacemaker, or other contraindication to transcranial magnetic stimulation
  6. Pregnant or breast feeding
  7. Previous electroconvulsive therapy (ECT)
  8. Poor mobility
  9. Visual impairment
  10. Lack of social support / home to go to after the study treatment
  11. Alcohol dependency
  12. PaCO2 >6kPa at rest
  13. Inability to provide informed consent

Information from the National Library of Medicine

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 identifier (NCT number): NCT00830921

United Kingdom
Oxford Centre for Respiratory Medicine
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
University of Oxford
Study Director: Robert Davies Oxford Centre For Respiratory Medicine

Responsible Party: University of Oxford Identifier: NCT00830921     History of Changes
Other Study ID Numbers: 07/Q1607/48
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: June 2012

Keywords provided by University of Oxford:
Histocytologically proven thoracic malignancy

Additional relevant MeSH terms: