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

June 15, 2012 updated by: University of Oxford

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 7LJ
        • Oxford Centre for Respiratory Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients attending out-patient clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Study Director: Robert Davies, Oxford Centre for Respiratory Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (Estimate)

January 28, 2009

Study Record Updates

Last Update Posted (Estimate)

June 18, 2012

Last Update Submitted That Met QC Criteria

June 15, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07/Q1607/48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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