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A Randomised Crossover Study to Investigate the Effect of Transcranial Magnetic Stimulation of the Anterior Cingulate Cortex on "Air Hunger"


N/A
18 Years
N/A
Not Enrolling
Both
Malignancy

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Trial Information

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.


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

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Robert Davies

Investigator Role:

Study Director

Investigator Affiliation:

Oxford Centre For Respiratory Medicine

Authority:

United Kingdom: Research Ethics Committee

Study ID:

07/Q1607/48

NCT ID:

NCT00830921

Start Date:

February 2008

Completion Date:

January 2012

Related Keywords:

  • Malignancy
  • Histocytologically proven thoracic malignancy
  • Neoplasms

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