Brain TumorsNCT01018290
Navigated Transcranial Magnetic Stimulation in Tumor Surgery
An observational study of Brain Tumors, run by Nexstim Ltd at 1 site in United States.
Trial summary
Maximizing surgical removal of brain tumors while minimizing neurologic deficits is challenging. Functional brain tissue may reside close to or even within the abnormality, and inadvertent removal or disturbance of such areas can result in neurologic deficits. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Tumors
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Sep 2010
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 patients with brain tumor in the vicinity of the central motor region scheduled for elective surgery.Patients aged 18 and over with no other brain abnormalities.
Who may be able to join
- Male or female subjects 18 years of age and over.
- A brain tumor in the vicinity of the central region.
- Mild (BMRC grade 4/5) or no paresis.
- Obscured anatomy of the central region due to the mass effect/infiltrating growth pattern of the lesion
- Scheduled for elective surgery under general or local anesthesia.
- No other known brain abnormalities by history or by structural MRI.
- Mentally and physically able to undergo MR imaging (fMRI, DTI) and navigated TMS studies
- Signed informed consent form.
Who cannot join
- Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump.
- Pregnant or trying to become pregnant.
- History of alcohol abuse, illicit drug use or drug abuse or significant mental illness
- Hypertensive or hypotensive condition.
- Any condition that would prevent the subject from giving voluntary informed consent.
- An implanted brain stimulator.
Show all 11Show fewer
- Aneurysm clip or other metal in the head (except mouth
- Enrolled or plans to enroll in an interventional trial during this study.
- Scalp wounds or infections.
- Claustrophobia precluding MRI
- Frequent seizures (>1/week)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Preoperative Non-Invasive Motor Mapping in Tumor Surgery by Navigated Transcranial Magnetic Stimulation
Maximizing surgical removal of brain tumors while minimizing neurologic deficits is challenging. Functional brain tissue may reside close to or even within the abnormality, and inadvertent removal or disturbance of such areas can result in neurologic deficits. At present, the gold standard for identifying critical motor areas in tumor surgery is intraoperative invasive direct current stimulation (DCS) through a handpiece. More recently, new non-invasive preoperative method for brain mapping, functional magnetic resonance imaging (fMRI), may be used to identify the eloquent motor areas. fMRI signals used in localization of the motor areas are generated when the brain is activated during the performance of specific motor tasks. However, as fMRI signals are also generated by sensory input, the resulting fMRI map may include sensory as well as motor areas.
Nexstim has developed a Navigated Brain Stimulation (NBS) system that uses TMS with a software based Navigational System that together may have more specific spatial accuracy.
This study aims to determine whether navigated TMS is able to identify the eloquent motor cortical areas in patients with brain tumors and to determine the clinical accuracy of the procedure by comparing it to results obtained by intraoperative DCS and fMRI.
- Conditions
- Brain Tumors
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Navigated TMS examination | 20 patients with brain tumor in the vicinity of the central motor region scheduled for elective surgery will undergo pre-operative Navigated TMS examination to determine the localization of primary motor cortex and motor representation areas of specific muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between motor representation area localization by NBS to that determined by DCS
Measured: immediate post-operative period
Comparison of DTI results based on using NBS motor representations as seed to those obtained using DCS results as seeds
Measured: immediate post-operative period
Secondary outcomes (2)
Comparison of the relative distance of NBS anf fMRI identified motor representations to those determined by DCS
Measured: immediate post-operative period
Assess safety of navigated TMS in this patient population by capturing all Serious Adverse Events
Measured: During and after navigated TMS examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Recruitment goals not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nexstim Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alexandra Golby, MD, Principal investigator, Brigham and Women's Hospital Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018290
- Sponsor's protocol ID
- 2008-P-002325/2
- Status last verified
- Jun 2011
- First submitted
- 20 Nov 2009
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Non-Invasive Motor Mapping in Tumor Surgery by Navigated Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT01018290
- Acronym / sponsor ID
- 2008-P-002325/2
- Conditions
- Brain Tumors
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment goals not met
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nexstim LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Nov 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.
Maximizing surgical removal of brain tumors while minimizing neurologic deficits is challenging. Functional brain tissue may reside close to or even within the abnormality, and inadvertent removal or disturbance of such areas can result in neurologic deficits. At present, the gold standard for identifying critical motor areas in tumor surgery is intraoperative invasive direct current stimulation (DCS) through a handpiece. More recently, new non-invasive preoperative method for brain mapping, functional magnetic resonance imaging (fMRI), may be used to identify the eloquent motor areas. fMRI signals used in localization of the motor areas are generated when the brain is activated during the performance of specific motor tasks. However, as fMRI signals are also generated by sensory input, the resulting fMRI map may include sensory as well as motor areas.
Nexstim has developed a Navigated Brain Stimulation (NBS) system that uses TMS with a software based Navigational System that together may have more specific spatial accuracy.
This study aims to determine whether navigated TMS is able to identify the eloquent motor cortical areas in patients with brain tumors and to determine the clinical accuracy of the procedure by comparing it to results obtained by intraoperative DCS and fMRI.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Navigated TMS examination | – | –20 patients with brain tumor in the vicinity of the central motor region scheduled for elective surgery will undergo pre-operative Navigated TMS examination to determine the localization of primary motor cortex and motor representation areas of specific muscles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients with brain tumor in the vicinity of the central motor region scheduled for elective surgery.Patients aged 18 and over with no other brain abnormalities.
Key inclusion criteria (8 listed)
- Male or female subjects 18 years of age and over.
- A brain tumor in the vicinity of the central region.
- Mild (BMRC grade 4/5) or no paresis.
- Obscured anatomy of the central region due to the mass effect/infiltrating growth pattern of the lesion
- Scheduled for elective surgery under general or local anesthesia.
Key exclusion criteria (11 listed)
- Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump.
- Pregnant or trying to become pregnant.
- History of alcohol abuse, illicit drug use or drug abuse or significant mental illness
- Hypertensive or hypotensive condition.
- Any condition that would prevent the subject from giving voluntary informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distance between motor representation area localization by NBS to that determined by DCS
Time frame: immediate post-operative period
Comparison of DTI results based on using NBS motor representations as seed to those obtained using DCS results as seeds
Time frame: immediate post-operative period
2 secondary outcomes
Comparison of the relative distance of NBS anf fMRI identified motor representations to those determined by DCS
Time frame: immediate post-operative period
Assess safety of navigated TMS in this patient population by capturing all Serious Adverse Events
Time frame: During and after navigated TMS examination
Results and safety
The study was stopped early (reason given: Recruitment goals not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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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.
Alexandra Golby, MD principal investigator
Brigham and Women's Hospital Harvard Medical School
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 Brain Tumors, run by Nexstim Ltd at 1 site in United States.
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 8 inclusion and 11 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 8 Jun 2011. 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 States. 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: Recruitment goals not met). 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.
What does the primary outcome measure?
Distance between motor representation area localization by NBS to that determined by DCS (time frame: immediate post-operative period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 8 Jun 2011.