Impact of Cerebellar Mass Resection on Pain Processing

The Impact of Cerebellar Mass Resection on Pain Processing

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.

Study Overview

• Status: Completed
• Conditions: Cerebellar Neoplasm
• Intervention / Treatment: Device: Medoc Advanced Medical Systems PATHWAY Model ATS; Procedure: Cold water bath; Device: MRI scanner; Other: Questionnaires

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.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02453
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 38 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with cerebellar resection and healthy volunteers.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: 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.; Procedure: 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.; Device: 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.; Other: 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	Device: 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.; Procedure: 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.; Device: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Eric Moulton, Ph.D, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 2, 2014
• First Submitted That Met QC Criteria: October 7, 2014
• First Posted (Estimate): October 10, 2014

Study Record Updates

• Last Update Posted (Actual): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Cerebellar tumor; Non-malignant low-grade cerebellar astrocytomas
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Cerebellar Diseases; Infratentorial Neoplasms; Cerebellar Neoplasms
• Other Study ID Numbers: 14-104; 1R21CA185870-01 (U.S. NIH Grant/Contract)