Impact of Cerebellar Mass Resection on Pain Processing

Completed

• Conditions: Cerebellar Neoplasm
• Interventions: Device: Medoc Advanced Medical Systems PATHWAY Model ATS; Procedure: Cold water bath; Device: MRI scanner; Other: Questionnaires

• Registration Number: NCT02261649
• Lead Sponsor: Dana-Farber Cancer Institute

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 following surgery, the investigators hope to gain valuable information about pain processing in the brain.

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 a healthy volunteer with no history of pain disorders or mental illness. The study will involve sensory testing and brain imaging using magnetic resonance imaging (MRI) Sensory testing will be performed using a tub of cold water, as well as a contact thermode capable of delivering hot and cold temperatures. MRI brain scanning uses magnetic fields and radio waves to give pictures of the brain without using radiation.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-10
• Primary Completion: 2017-04
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteer	Questionnaires	Quantitative Sensory Testing and Neuroimaging * Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator) * Cold water bath * MRI scanner * Questionnaires
Cerebellar Tumor Surgically Removed	Medoc Advanced Medical Systems PATHWAY Model ATS	Quantitative Sensory Testing and Neuroimaging * Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator) * Cold water bath * MRI scanner * Questionnaires
Cerebellar Tumor Surgically Removed	MRI scanner	Quantitative Sensory Testing and Neuroimaging * Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator) * Cold water bath * MRI scanner * Questionnaires
Healthy Volunteer	Cold water bath	Quantitative Sensory Testing and Neuroimaging * Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator) * Cold water bath * MRI scanner * Questionnaires
Cerebellar Tumor Surgically Removed	Cold water bath	Quantitative Sensory Testing and Neuroimaging * Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator) * Cold water bath * MRI scanner * Questionnaires
Healthy Volunteer	Medoc Advanced Medical Systems PATHWAY Model ATS	Quantitative Sensory Testing and Neuroimaging * Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator) * Cold water bath * MRI scanner * Questionnaires
Cerebellar Tumor Surgically Removed	Questionnaires	Quantitative Sensory Testing and Neuroimaging * Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator) * Cold water bath * MRI scanner * Questionnaires
Healthy Volunteer	MRI scanner	Quantitative Sensory Testing and Neuroimaging * Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator) * Cold water bath * MRI scanner * Questionnaires

Primary Outcome Measures

Name	Time	Method
Increase in blood oxygen level dependent signal response	Baseline, Day 1	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.

Secondary Outcome Measures

Name	Time	Method
Behavior Rating Inventory of Executive Function-Adult version scores	Baseline, Day 1	Assesses executive function
Fear of Pain Questionnaire-Child scores	Baseline, Day 1	Assesses fear of pain
Multidimensional Anxiety Scale for Children scores	Baseline, Day 1	Assesses anxiety
Behavior Rating Inventory of Executive Function scores	Baseline, Day 1	Assesses executive function
Fear of Pain Questionnaire III-Adult scores	Baseline, Day 1	Assesses fear of pain
Multidimensional Anxiety Questionnaire-Adult scores	Baseline, Day 1	Assesses anxiety

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Waltham, Massachusetts, United States