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Completed

NCT Number: NCT02261649

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.

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Key information

Age range

6 year–38 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Waltham, Massachusetts, 02453, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Increase in blood oxygen level dependent signal response

    Time frame: 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 outcomes

  1. Fear of Pain Questionnaire-Child scores

    Time frame: Baseline, Day 1

    Assesses fear of pain

  2. Multidimensional Anxiety Scale for Children scores

    Time frame: Baseline, Day 1

    Assesses anxiety

  3. Behavior Rating Inventory of Executive Function scores

    Time frame: Baseline, Day 1

    Assesses executive function

  4. Fear of Pain Questionnaire III-Adult scores

    Time frame: Baseline, Day 1

    Assesses fear of pain

  5. Multidimensional Anxiety Questionnaire-Adult scores

    Time frame: Baseline, Day 1

    Assesses anxiety

  6. Behavior Rating Inventory of Executive Function-Adult version scores

    Time frame: Baseline, Day 1

    Assesses executive function

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

The Impact of Cerebellar Mass Resection on Pain Processing

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 10, 2014
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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