NCT00830921

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

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

June 18, 2012

Status Verified

June 1, 2012

First QC Date

January 27, 2009

Last Update Submit

June 15, 2012

Conditions

Keywords

Histocytologically proven thoracic malignancy

Study Arms (1)

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

Interventions

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients attending out-patient clinic

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Centre for Respiratory Medicine

Oxford, OX3 7LJ, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Robert Davies

    Oxford Centre For Respiratory Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 28, 2009

Study Start

February 1, 2008

Study Completion

January 1, 2012

Last Updated

June 18, 2012

Record last verified: 2012-06

Locations