Clinical trial · Observational
Impact of Cerebellar Mass Resection on Pain Processing
The Impact of Cerebellar Mass Resection on Pain Processing
NCT02261649CI-TRIAL-00031487completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cerebellar Neoplasm | Cerebellar Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cold water bath | Procedure | — | UNRESOLVED |
| Medoc Advanced Medical Systems PATHWAY Model ATS | Device | — | UNRESOLVED |
| MRI scanner | Device | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cerebellar Tumor Surgically Removed
- description
- Quantitative Sensory Testing and Neuroimaging * Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator) * Cold water bath * MRI scanner * Questionnaires
- interventionNames
- Device: Medoc Advanced Medical Systems PATHWAY Model ATS
- Procedure: Cold water bath
- Device: MRI scanner
- Other: Questionnaires
- label
- Healthy Volunteer
- description
- Quantitative Sensory Testing and Neuroimaging * Medoc Advanced Medical Systems PATHWAY Model ATS (Contact thermal stimulator) * Cold water bath * MRI scanner * Questionnaires
- interventionNames
- Device: Medoc Advanced Medical Systems PATHWAY Model ATS
- Procedure: Cold water bath
- Device: MRI scanner
- Other: Questionnaires
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 38 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.