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

This study has been terminated.
(Lack of patients)
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT00830921
First received: January 27, 2009
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Malignancy
 Device: Transcranial Magnetic Stimulation

Study Type: Observational
Official Title: A Randomised Crossover Study to Investigate the Effect of Transcranial Magnetic Stimulation of the Anterior Cingulate Cortex on "Air Hunger"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oxford:

Estimated Enrollment: 12
Study Start Date: February 2008
Study Completion Date: January 2012
Groups/Cohorts Assigned Interventions
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.

 Device: Transcranial Magnetic Stimulation
Transcranial magnetic stimulation (TMS) is a non-invasive method for altering brain activity in vivo.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients attending out-patient clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830921

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

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT00830921     History of Changes
Other Study ID Numbers: 07/Q1607/48
Study First Received: January 27, 2009
Last Updated: June 15, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
Histocytologically proven thoracic malignancy

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013