Cerebellar Neoplasm Clinical Trial
Official title:
The Impact of Cerebellar Mass Resection on Pain Processing
Verified date | January 2018 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 following surgery, the investigators hope to gain valuable information about pain processing in the brain.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 38 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Waltham | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | National Cancer Institute (NCI), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increase in blood oxygen level dependent signal response | Functional magnetic resonance imaging scans will be collected to measure blood oxygen level dependent (BOLD) responses, an indirect measure measure of neural activity. The Unit of Measure is % BOLD signal change across spatiotemporal domains within the brain. | Baseline, Day 1 | |
Secondary | Fear of Pain Questionnaire-Child scores | Assesses fear of pain | Baseline, Day 1 | |
Secondary | Multidimensional Anxiety Scale for Children scores | Assesses anxiety | Baseline, Day 1 | |
Secondary | Behavior Rating Inventory of Executive Function scores | Assesses executive function | Baseline, Day 1 | |
Secondary | Fear of Pain Questionnaire III-Adult scores | Assesses fear of pain | Baseline, Day 1 | |
Secondary | Multidimensional Anxiety Questionnaire-Adult scores | Assesses anxiety | Baseline, Day 1 | |
Secondary | Behavior Rating Inventory of Executive Function-Adult version scores | Assesses executive function | Baseline, Day 1 |