Cerebellar NeoplasmNCT02261649
Impact of Cerebellar Mass Resection on Pain Processing
An observational study of Cerebellar Neoplasm, run by Dana-Farber Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebellar Neoplasm
- What is being tested?
- Medoc Advanced Medical Systems PATHWAY Model ATS, Cold water bath and MRI scanner
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 38 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with cerebellar resection and healthy volunteers.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Waltham, Massachusetts, 02453
About this study
Official title: The 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.
Read the 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.
- Conditions
- Cerebellar Neoplasm
- Being tested
- Medoc Advanced Medical Systems PATHWAY Model ATS, Cold water bath, MRI scanner, Questionnaires
- Keywords
- Cerebellar tumor, Non-malignant low-grade cerebellar astrocytomas
- Medical subject headings
- Cerebellar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medoc Advanced Medical Systems PATHWAY Model ATSDevice
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 bathProcedure or surgery
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 scannerDevice
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.
QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Medoc Advanced Medical Systems PATHWAY Model ATS; Procedure: Cold water bath; Device: MRI scanner; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 1
Secondary outcomes (6)
Fear of Pain Questionnaire-Child scores
Assesses fear of pain
Measured: Baseline, Day 1
Multidimensional Anxiety Scale for Children scores
Assesses anxiety
Measured: Baseline, Day 1
Behavior Rating Inventory of Executive Function scores
Assesses executive function
Measured: Baseline, Day 1
Fear of Pain Questionnaire III-Adult scores
Assesses fear of pain
Measured: Baseline, Day 1
Multidimensional Anxiety Questionnaire-Adult scores
Assesses anxiety
Measured: Baseline, Day 1
Behavior Rating Inventory of Executive Function-Adult version scores
Assesses executive function
Measured: Baseline, Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar NeoplasmStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Eric Moulton, PhD, Dana-Farber Cancer Institute
- Investigators
- Eric Moulton, Ph.D, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261649
- Sponsor's protocol ID
- 14-104
- Other IDs
- 1R21CA185870-01
- Status last verified
- Jan 2018
- First submitted
- 2 Oct 2014
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cerebellar Mass Resection on Pain Processing
- ClinicalTrials.gov ID
- NCT02261649
- Acronym / sponsor ID
- 14-104
- Conditions
- Cerebellar Neoplasm
- Keywords
- Cerebellar tumor, Non-malignant low-grade cerebellar astrocytomas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Oct 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebellar Tumor Surgically Removed | – | Device: Medoc Advanced Medical Systems PATHWAY Model ATS, Procedure: Cold water bath, Device: MRI scanner, Other: QuestionnairesQuantitative Sensory Testing and Neuroimaging * Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator) * Cold water bath * MRI scanner * Questionnaires |
| Healthy Volunteer | – | Device: Medoc Advanced Medical Systems PATHWAY Model ATS, Procedure: Cold water bath, Device: MRI scanner, Other: QuestionnairesQuantitative Sensory Testing and Neuroimaging * Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator) * Cold water bath * MRI scanner * Questionnaires |
Who may qualify
- Ages
- 6 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with cerebellar resection and healthy volunteers.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medoc Advanced Medical Systems PATHWAY Model ATS30 minutes of sensory testing using a contact thermal stimulator will measure thresholds for heat and cool detection, and threshold for hot and cold pain. | Device | Cerebellar Tumor Surgically Removed, Healthy Volunteer |
| Cold water bathThe 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. | Procedure or surgery | Cerebellar Tumor Surgically Removed, Healthy Volunteer |
| MRI scannerAn MRI will be used to collect anatomical and functional images from patients and subjects. These data will be collected within a 1 hour block. | Device | Cerebellar Tumor Surgically Removed, Healthy Volunteer |
| QuestionnairesThe 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. | Other | Cerebellar Tumor Surgically Removed, Healthy Volunteer |
Primary outcome
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.
6 secondary outcomes
Fear of Pain Questionnaire-Child scores
Time frame: Baseline, Day 1
Multidimensional Anxiety Scale for Children scores
Time frame: Baseline, Day 1
Behavior Rating Inventory of Executive Function scores
Time frame: Baseline, Day 1
Fear of Pain Questionnaire III-Adult scores
Time frame: Baseline, Day 1
Multidimensional Anxiety Questionnaire-Adult scores
Time frame: Baseline, Day 1
Behavior Rating Inventory of Executive Function-Adult version scores
Time frame: Baseline, Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Moulton, Ph.D principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebellar Neoplasm, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in blood oxygen level dependent signal response (time frame: Baseline, Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.