Brain NeoplasmsNCT02795338
Multi-modality Localization of Eloquent Brain Function
An observational study of Brain Neoplasms, run by University of Nebraska.
Trial summary
Accurate identification of areas of eloquent brain function is vital to surgical decision making and to preservation of independence as patients with brain tumors who are higher functioning have better survival outcomes. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- brain mapping
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Feb 2018to 27 Feb 2018
- How long will I take part?
- 6 Months
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We propose enrolling 80 patients with brain tumors in or near eloquent brain regions who are appropriate candidates for surgery.
Who may be able to join
- informed consent
- age equal to or greater than 19 years
- gender: male and female included
- brain tumor in or near an eloquent area of the brain that requires surgery
- benign or malignant intra-axial brain tumor
- primary or secondary intra-axial brain tumor
- appropriate body habitus for operating room positioning and airway protection for awake mapping
- appropriate mental status and capacity to participate with invasive or non-invasive mapping
Who cannot join
- any contraindication to MRI (i.e. implanted devices)
- inappropriate body habitus for safe positioning or airway protection
- no capacity to understand the study the study or consent to it
- significant disability precluding successful mapping
- positive pregnancy test in females
- end stage renal disease or severe renal dysfunction
Show all 9Show fewer
- sleep apnea or any obstructive airway disease
- severe anxiety disorder
- metabolic encephalopathy
About this study
Official title: Multi-modality Localization of Eloquent Brain Function-A Comparison of Technologies for Improved Applicability
Accurate identification of areas of eloquent brain function is vital to surgical decision making and to preservation of independence as patients with brain tumors who are higher functioning have better survival outcomes. Eloquent brain is defined as a region controlling language, motor, or sensory function such that without its proper input, a person would be left with significant neurologic deficits. Imaging technology has evolved to provide multiple non-invasive modalities for pre-operative testing of eloquent brain function. Studies have shown that these non-invasive mapping modalities provide useful information, however, the information provided inconsistently predicts distribution of eloquent function.
Direct electrical stimulation (DES) at surgery allows assessment of eloquent function directly from the brain surface (invasive) and is considered the gold standard in brain mapping. Therefore, in order to determine the true clinical applicability of the non-invasive mapping technologies, this study proposes to assess the predictive value of functional MRI (fMRI) and magnetoencephalography (MEG) for sensorimotor and language functions by comparing results to DES and determine whether fMRI or MEG provides the most consistent and accurate information. The rationale for the proposed research is that understanding the reliability of our current technology will allow us to perform safer surgeries and to preserve neurologic function.
Read the detailed description
It is unknown whether imaging technologies have broad applications in brain mapping due to limited knowledge of the value of the results. Accurate identification of areas of eloquent brain function is vital to surgical decision making and to preservation of independence as patients with brain tumors who are higher functioning have better survival outcomes. Imaging technology has evolved to provide multiple non-invasive modalities for pre-operative testing of eloquent brain function and include functional MRI (fMRI) and magnetoencephalography (MEG). Eloquent brain is defined as a region controlling language, motor, or sensory function such that without its proper input, a person would be left with significant neurologic deficits. Studies conducted have shown that these non-invasive mapping modalities provide useful information, however, the information provided inconsistently predicts distribution of eloquent function.
Direct electrical stimulation (DES) at the time of surgery allows assessment of eloquent function directly from the brain surface (invasive) and is considered the gold standard in brain mapping. Therefore, in order to determine the true clinical applicability of the non-invasive mapping technologies, this study proposes to: (1) assess the predictive value of fMRI and MEG for sensorimotor and language functions by comparing their results to DES and (2) determine whether fMRI or MEG provides the most consistent and accurate information. These aims will be accomplished by by co-registering all mapping data (invasive and non-invasive) in a modifiable 3D rendering. In this way, the DES to fMRI and MEG can be evaluated as well as fMRI to MEG compared. The rationale for the proposed research is that understanding the reliability of our current technology will allow for safer surgeries and preservation of neurologic function. The expected outcomes for the work proposed in Aims 1 and 2 are identification of a predictive value for fMRI and MEG and determination if one modality should be utilized over the other pre-operatively for the most accurate information. The results of this study are expected to have an important positive impact because identification of accurate pre-operative non-invasive mapping modalities will allow tailored testing and possibly lead to negation of the need for intra-operative mapping in certain cases. It will also enhance patient outcomes by improving patient safety. Furthermore, it will serve as the basis for a multi-institutional mapping data bank.
- Conditions
- Brain Neoplasms
- Being tested
- brain mapping
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brain mappingProcedure or surgery
pre-operative and intra-operative brain mapping to identify eloquent areas
What is being measured
The primary outcome is the main question the study is designed to answer.
Location in the brain of the fMRI activations relative to intra-operative brain mapping
Assess the predictive value of fMRI for language and sensorimotor function by evaluating the location in the brain where the activity was found. The pre-operative locations will be compared to the intra-operative locations which are considered the gold standard. If the fMRI activations indicate the same gyrus/gyri as the intra-operative mapping, it is considered accurate. This is accomplished with special techniques integrating multiple data time points and types.
Measured: 5 years
Location in the brain of the MEG activations relative to intra-operative brain mapping
Assess the predictive value of MEG for language and sensorimotor function by evaluating the location in the brain where the activity was found. The pre-operative locations will be compared to the intra-operative locations which are considered the gold standard. If the MEG activations indicate the same gyrus/gyri as the intra-operative mapping, it is considered accurate. This is accomplished with special techniques integrating multiple data time points and types.
Measured: 5 years
Accuracy of fMRI and MEG in pre-operative brain mapping
Assess which mapping method provides the most consistent and accurate information in pre-operative mapping for language and sensorimotor function. Determination of the testing method that most often identifies the correct anatomic location of the eloquent function as dictated by the findings from outcomes 1 and 2.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start27 Feb 2018
- Primary completion27 Feb 2018
- Study completion27 Feb 2018
Why it stopped: Project did not receive funding and was never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele R Aizenberg Ansari, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795338
- Sponsor's protocol ID
- 0176-16-EP
- Status last verified
- Aug 2024
- First submitted
- 24 May 2016
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modality Localization of Eloquent Brain Function-A Comparison of Technologies for Improved Applicability
- ClinicalTrials.gov ID
- NCT02795338
- Acronym / sponsor ID
- 0176-16-EP
- Conditions
- Brain Neoplasms
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Project did not receive funding and was never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 27 Feb 2018 (actual)
- First posted
- 10 Jun 2016 (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.
Accurate identification of areas of eloquent brain function is vital to surgical decision making and to preservation of independence as patients with brain tumors who are higher functioning have better survival outcomes. Eloquent brain is defined as a region controlling language, motor, or sensory function such that without its proper input, a person would be left with significant neurologic deficits. Imaging technology has evolved to provide multiple non-invasive modalities for pre-operative testing of eloquent brain function. Studies have shown that these non-invasive mapping modalities provide useful information, however, the information provided inconsistently predicts distribution of eloquent function.
Direct electrical stimulation (DES) at surgery allows assessment of eloquent function directly from the brain surface (invasive) and is considered the gold standard in brain mapping. Therefore, in order to determine the true clinical applicability of the non-invasive mapping technologies, this study proposes to assess the predictive value of functional MRI (fMRI) and magnetoencephalography (MEG) for sensorimotor and language functions by comparing results to DES and determine whether fMRI or MEG provides the most consistent and accurate information. The rationale for the proposed research is that understanding the reliability of our current technology will allow us to perform safer surgeries and to preserve neurologic function.
Detailed description
It is unknown whether imaging technologies have broad applications in brain mapping due to limited knowledge of the value of the results. Accurate identification of areas of eloquent brain function is vital to surgical decision making and to preservation of independence as patients with brain tumors who are higher functioning have better survival outcomes. Imaging technology has evolved to provide multiple non-invasive modalities for pre-operative testing of eloquent brain function and include functional MRI (fMRI) and magnetoencephalography (MEG). Eloquent brain is defined as a region controlling language, motor, or sensory function such that without its proper input, a person would be left with significant neurologic deficits. Studies conducted have shown that these non-invasive mapping modalities provide useful information, however, the information provided inconsistently predicts distribution of eloquent function.
Direct electrical stimulation (DES) at the time of surgery allows assessment of eloquent function directly from the brain surface (invasive) and is considered the gold standard in brain mapping. Therefore, in order to determine the true clinical applicability of the non-invasive mapping technologies, this study proposes to: (1) assess the predictive value of fMRI and MEG for sensorimotor and language functions by comparing their results to DES and (2) determine whether fMRI or MEG provides the most consistent and accurate information. These aims will be accomplished by by co-registering all mapping data (invasive and non-invasive) in a modifiable 3D rendering. In this way, the DES to fMRI and MEG can be evaluated as well as fMRI to MEG compared. The rationale for the proposed research is that understanding the reliability of our current technology will allow for safer surgeries and preservation of neurologic function. The expected outcomes for the work proposed in Aims 1 and 2 are identification of a predictive value for fMRI and MEG and determination if one modality should be utilized over the other pre-operatively for the most accurate information. The results of this study are expected to have an important positive impact because identification of accurate pre-operative non-invasive mapping modalities will allow tailored testing and possibly lead to negation of the need for intra-operative mapping in certain cases. It will also enhance patient outcomes by improving patient safety. Furthermore, it will serve as the basis for a multi-institutional mapping data bank.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We propose enrolling 80 patients with brain tumors in or near eloquent brain regions who are appropriate candidates for surgery.
Key inclusion criteria (8 listed)
- informed consent
- age equal to or greater than 19 years
- gender: male and female included
- brain tumor in or near an eloquent area of the brain that requires surgery
- benign or malignant intra-axial brain tumor
Key exclusion criteria (9 listed)
- any contraindication to MRI (i.e. implanted devices)
- inappropriate body habitus for safe positioning or airway protection
- no capacity to understand the study the study or consent to it
- significant disability precluding successful mapping
- positive pregnancy test in females
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 |
|---|---|---|
| brain mappingpre-operative and intra-operative brain mapping to identify eloquent areas | Procedure or surgery | – |
Primary outcome
Location in the brain of the fMRI activations relative to intra-operative brain mapping
Time frame: 5 years
Assess the predictive value of fMRI for language and sensorimotor function by evaluating the location in the brain where the activity was found. The pre-operative locations will be compared to the intra-operative locations which are considered the gold standard. If the fMRI activations indicate the same gyrus/gyri as the intra-operative mapping, it is considered accurate. This is accomplished with special techniques integrating multiple data time points and types.
Location in the brain of the MEG activations relative to intra-operative brain mapping
Time frame: 5 years
Assess the predictive value of MEG for language and sensorimotor function by evaluating the location in the brain where the activity was found. The pre-operative locations will be compared to the intra-operative locations which are considered the gold standard. If the MEG activations indicate the same gyrus/gyri as the intra-operative mapping, it is considered accurate. This is accomplished with special techniques integrating multiple data time points and types.
Accuracy of fMRI and MEG in pre-operative brain mapping
Time frame: 5 years
Assess which mapping method provides the most consistent and accurate information in pre-operative mapping for language and sensorimotor function. Determination of the testing method that most often identifies the correct anatomic location of the eloquent function as dictated by the findings from outcomes 1 and 2.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Michele R Aizenberg Ansari, MD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Neoplasms, run by University of Nebraska.
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 9 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: withdrawn, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Location in the brain of the fMRI activations relative to intra-operative brain mapping (time frame: 5 years). The study lists 3 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 3 Sep 2024.