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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02261649
Other study ID # 14-104
Secondary ID 1R21CA185870-01
Status Completed
Phase N/A
First received October 2, 2014
Last updated January 30, 2018
Start date October 2014
Est. completion date December 2017

Study information

Verified date January 2018
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 2017
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 38 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Boston Children's Hospital Waltham Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

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