Status:
COMPLETED
Impact of Cerebellar Mass Resection on Pain Processing
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Cerebellar Neoplasm
Eligibility:
All Genders
6-38 years
Brief Summary
The purpose of the study is to evaluate how cerebellar resection surgery may affect pain sensation and the way the brain "reads" pain signals. By measuring brain activity in children and adolescents f...
Detailed Description
This study is designed to test whether cerebellar resection surgery affects pain pathways in the brain. To participate a participant must (A) have had a cerebellar mass surgically removed, or (B) are ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for patients:
- Age 4-18 years old at the time of surgery
- 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
- Inclusion Criteria for all subjects:
- 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:
- Claustrophobia
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02261649
Start Date
October 1 2014
End Date
December 1 2017
Last Update
February 1 2018
Active Locations (1)
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1
Boston Children's Hospital
Waltham, Massachusetts, United States, 02453