MalignancyTMSNCT00830921
Does Transcranial Magnetic Stimulation of the Cingulate Cortex Modulate the Perception of Dyspnoea?
An observational study of Malignancy, run by University of Oxford at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancy
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2008to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending out-patient clinic
Who may be able to join
- Refractory dyspnoea (persisting sensation of air hunger despite optimisation of medical treatment)
- Histocytologically proven thoracic malignancy
- Written informed consent
Who cannot join
- Age <18 years
- Left-handed
- Structural brain disease (including cerebral metastasis)
- Personal or family history of seizures
- Implantable metallic objects e.g. a pacemaker, or other contraindication to transcranial magnetic stimulation
- Pregnant or breast feeding
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- Previous electroconvulsive therapy (ECT)
- Poor mobility
- Visual impairment
- Lack of social support / home to go to after the study treatment
- Alcohol dependency
- PaCO2 >6kPa at rest
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Centre for Respiratory Medicine
Oxford, OX3 7LJ
About this study
Official title: 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
Read the 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.
- Conditions
- Malignancy
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Histocytologically proven thoracic malignancy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Transcranial magnetic stimulation (TMS) is a non-invasive method for altering brain activity in vivo.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranial Magnetic Stimulation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startFeb 2008
- Study completionJan 2012
Why it stopped: Lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Davies, Study director, Oxford Centre For Respiratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830921
- Sponsor's protocol ID
- 07/Q1607/48
- Acronym
- TMS
- Status last verified
- Jun 2012
- First submitted
- 27 Jan 2009
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Crossover Study to Investigate the Effect of Transcranial Magnetic Stimulation of the Anterior Cingulate Cortex on "Air Hunger"
- ClinicalTrials.gov ID
- NCT00830921
- Acronym / sponsor ID
- TMS / 07/Q1607/48
- Conditions
- Malignancy
- Keywords
- Histocytologically proven thoracic malignancy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of patients
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Feb 2008
- Study completion
- Jan 2012 (actual)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) 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 design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Transcranial Magnetic StimulationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending out-patient clinic
Key inclusion criteria (3 listed)
- Refractory dyspnoea (persisting sensation of air hunger despite optimisation of medical treatment)
- Histocytologically proven thoracic malignancy
- Written informed consent
Key exclusion criteria (13 listed)
- Age <18 years
- Left-handed
- Structural brain disease (including cerebral metastasis)
- Personal or family history of seizures
- Implantable metallic objects e.g. a pacemaker, or other contraindication to transcranial magnetic stimulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationTranscranial magnetic stimulation (TMS) is a non-invasive method for altering brain activity in vivo. | Device | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Lack of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Davies study director
Oxford Centre For Respiratory Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignancy, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2012.