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Impact of Cerebellar Mass Resection on Pain Processing

The Impact of Cerebellar Mass Resection on Pain Processing

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02261649
Enrollment
24
Registered
2014-10-10
Start date
2014-10-31
Completion date
2017-12-31
Last updated
2018-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebellar Neoplasm

Keywords

Cerebellar tumor, Non-malignant low-grade cerebellar astrocytomas

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.

Interventions

DEVICEMedoc 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.

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.

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.

OTHERQuestionnaires

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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Cancer Institute (NCI)
CollaboratorNIH
Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 38 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Increase in blood oxygen level dependent signal responseBaseline, Day 1Functional 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

MeasureTime frameDescription
Multidimensional Anxiety Scale for Children scoresBaseline, Day 1Assesses anxiety
Behavior Rating Inventory of Executive Function scoresBaseline, Day 1Assesses executive function
Fear of Pain Questionnaire-Child scoresBaseline, Day 1Assesses fear of pain
Multidimensional Anxiety Questionnaire-Adult scoresBaseline, Day 1Assesses anxiety
Behavior Rating Inventory of Executive Function-Adult version scoresBaseline, Day 1Assesses executive function
Fear of Pain Questionnaire III-Adult scoresBaseline, Day 1Assesses fear of pain

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026