Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
24 participants
OBSERVATIONAL
2014-10-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cerebellar Tumor Surgically Removed
Quantitative Sensory Testing and Neuroimaging
* Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator)
* Cold water bath
* MRI scanner
* Questionnaires
Medoc Advanced Medical Systems PATHWAY Model ATS
30 minutes of sensory testing using a contact thermal stimulator will measure thresholds for heat and cool detection, and threshold for hot and cold pain.
Cold water bath
The next 15 minutes of sensory testing will measure tolerance to having right or left hand in a tub of cold water. The participant will place their hand in cold water and leave it there for as long they can, even if it is uncomfortable. The participant can take their arm out if it gets too uncomfortable to leave it in.
MRI scanner
An MRI will be used to collect anatomical and functional images from patients and subjects. These data will be collected within a 1 hour block.
Questionnaires
The surveys include questions about emotions, thoughts, and feelings. These surveys will be given before sensory testing and before the MRI scan. The parent or guardian will help to complete two surveys, and will complete one survey on his or her own. Questions can be skipped, and may be stopped at any time.
Healthy Volunteer
Quantitative Sensory Testing and Neuroimaging
* Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator)
* Cold water bath
* MRI scanner
* Questionnaires
Medoc Advanced Medical Systems PATHWAY Model ATS
30 minutes of sensory testing using a contact thermal stimulator will measure thresholds for heat and cool detection, and threshold for hot and cold pain.
Cold water bath
The next 15 minutes of sensory testing will measure tolerance to having right or left hand in a tub of cold water. The participant will place their hand in cold water and leave it there for as long they can, even if it is uncomfortable. The participant can take their arm out if it gets too uncomfortable to leave it in.
MRI scanner
An MRI will be used to collect anatomical and functional images from patients and subjects. These data will be collected within a 1 hour block.
Questionnaires
The surveys include questions about emotions, thoughts, and feelings. These surveys will be given before sensory testing and before the MRI scan. The parent or guardian will help to complete two surveys, and will complete one survey on his or her own. Questions can be skipped, and may be stopped at any time.
Interventions
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Medoc Advanced Medical Systems PATHWAY Model ATS
30 minutes of sensory testing using a contact thermal stimulator will measure thresholds for heat and cool detection, and threshold for hot and cold pain.
Cold water bath
The next 15 minutes of sensory testing will measure tolerance to having right or left hand in a tub of cold water. The participant will place their hand in cold water and leave it there for as long they can, even if it is uncomfortable. The participant can take their arm out if it gets too uncomfortable to leave it in.
MRI scanner
An MRI will be used to collect anatomical and functional images from patients and subjects. These data will be collected within a 1 hour block.
Questionnaires
The surveys include questions about emotions, thoughts, and feelings. These surveys will be given before sensory testing and before the MRI scan. The parent or guardian will help to complete two surveys, and will complete one survey on his or her own. Questions can be skipped, and may be stopped at any time.
Eligibility Criteria
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Inclusion Criteria
* Resection limited to the cerebellum
* Within 20 years of surgery
* Good physical health excluding symptoms directly related to cerebellar resection
* No cerebellar-mass directed treatment other than surgical resection
* Age 6-38 years old at the time of participation
* No paralysis/hemiparesis
* No motor deficits that would interfere with performance or required tasks (button press withdraw hand from water bath)
* English speaking sufficient to comprehend and provide assent with parental assistance or consent if over the age of 18
* Ability to complete MRI without sedation
Exclusion Criteria
* Significant medical (e.g. asthma, renal, cardiac, gastrointestinal or immunological) or brain- related disorders (e.g. seizures, autism, psychiatric conditions such as severe depression, psychosis)
* Metallic or magnetic implants that pose a risk to the participant or to the data quality
* Weight \> 285 pounds (weight limit of the fMRI table)
* History of drug abuse or positive drug screen
* Positive pregnancy screen
* Use of antidepressants or anticonvulsants, excepting patient usage after resection
* Significant alcohol history (ingestion of 5 or more glasses (\> 40 oz) of alcohol per week)
* Tattoos containing metallic ink on the neck, shoulders, upper arm and head (which could heat up in the scanner, and potentially cause blistering or burning)
* Cardiac pacemakers
* Aneurysm clips and other vascular stents, filters, clips or other devices
* Prosthetic heart valves
* Other prostheses
* Neuro-stimulator devices
* Implanted infusion pumps
* Cochlear (ear) implants
* Ocular (eye) implants or known metal fragments in eyes
* Exposure to shrapnel or metal filings (sheet metal workers, welders, and others)
* Participants that require anesthesia to complete an MRI scan
* Receipt of a medication via transdermal patch
6 Years
38 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Eric Moulton, PhD
Principal Investigator
Principal Investigators
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Eric Moulton, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Waltham, Massachusetts, United States
Countries
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Other Identifiers
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14-104
Identifier Type: -
Identifier Source: org_study_id
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