Impact of Cerebellar Mass Resection on Pain Processing

NCT02261649 | Completed DMC

• 2 other identifiers: 14-1041R21CA185870-01
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebellar Neoplasm

Keywords

Cerebellar tumor; Non-malignant low-grade cerebellar astrocytomas

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Fear of Pain Questionnaire-Child scores

  Baseline, Day 1

• Multidimensional Anxiety Scale for Children scores

  Baseline, Day 1

• Behavior Rating Inventory of Executive Function scores

  Baseline, Day 1

• Fear of Pain Questionnaire III-Adult scores

  Baseline, Day 1

• Multidimensional Anxiety Questionnaire-Adult scores

  Baseline, Day 1

Study Arms (2)

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; Procedure: Cold water bath; Device: MRI scanner; Other: Questionnaires

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; Procedure: Cold water bath; Device: MRI scanner; Other: Questionnaires

Interventions

Medoc Advanced Medical Systems PATHWAY Model ATS DEVICE

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.

Cerebellar Tumor Surgically Removed; Healthy Volunteer

Cold water bath PROCEDURE

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.

Cerebellar Tumor Surgically Removed; Healthy Volunteer

MRI scanner DEVICE

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.

Cerebellar Tumor Surgically Removed; Healthy Volunteer

Questionnaires OTHER

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.

Cerebellar Tumor Surgically Removed; Healthy Volunteer

Eligibility Criteria

• Age: 6 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cerebellar resection and healthy volunteers.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Boston Children's Hospital

Waltham, Massachusetts, 02453, United States

Location

MeSH Terms

Conditions

Cerebellar Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Infratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebellar Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eric Moulton, Ph.D

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 10, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

US (1)