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Impact of Cerebellar Mass Resection on Pain Processing

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ClinicalTrials.gov Identifier: NCT02261649
Recruitment Status : Completed
First Posted : October 10, 2014
Last Update Posted : February 1, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eric Moulton, PhD, 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.

Condition or disease Intervention/treatment
Cerebellar Neoplasm 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.

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Impact of Cerebellar Mass Resection on Pain Processing
Study Start Date : October 2014
Actual Primary Completion Date : April 2017
Actual Study Completion Date : December 2017

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 38 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with cerebellar resection and healthy volunteers.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261649


Locations
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United States, Massachusetts
Boston Children's Hospital
Waltham, Massachusetts, United States, 02453
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Eric Moulton, Ph.D Boston Children’s Hospital

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Responsible Party: Eric Moulton, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02261649     History of Changes
Other Study ID Numbers: 14-104
1R21CA185870-01 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Keywords provided by Eric Moulton, PhD, Dana-Farber Cancer Institute:
Cerebellar tumor
Non-malignant low-grade cerebellar astrocytomas
Additional relevant MeSH terms:
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Cerebellar Neoplasms
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