Clinical trial · Interventional
Central Pain Syndrome in Survivors of Head and Neck Cancer
Characterization of Central Pain Syndrome in Survivors of Head and Neck Cancer
NCT04128267CI-TRIAL-00060913terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment/accrual impacted by COVID and technical issues with equipment
Summary
Brief summary (as posted)
This is a cross-sectional pilot study of head and neck cancer survivors who have completed multi-modal treatment to assess and characterize the presence of distinct pain syndromes.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Correlative Studies | Other | — | UNRESOLVED |
| IPC-1000 | Device | — | UNRESOLVED |
| Magnetic resonance imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Response to Pain
- description
- Brain's response to pain using magnetic resonance imaging (MRI)
- interventionNames
- Device: IPC-1000
- Device: Magnetic resonance imaging
- Other: Correlative Studies
Primary outcomes (2)
- measure
- Magnetic Resonance Imaging (MRI) to Correlate With One of Three Pain Phenotypes 1) no Pain, 2) Central Pain, 3) Nociceptive Pain
- timeFrame
- Approximately 8 weeks
- description
- MRI scan of brain to measure response to stimulated pressure to thumbnail
- measure
- Magnetic Resonance Imaging (MRI) to Correlate Presence of Chronic Systemic Symptoms With Pain Phenotype
- timeFrame
- Approximately 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically proven head and neck cancer * Patients without a diagnosis of head and neck cancer (up to 10 patients, see below) * We anticipate enrolling a total of 75 patients with a history of head and neck cancer who will complete all questionnaires and MRI scanning. We will also recruit up to 10 patients WITHOUT a diagnosis of head and neck cancer to facilitate optimization of the MRI scanning processes. This will allow us to address logistical issues, such as pressure stimulator setup and timing of each scan to be performed. * Completed multi-modality therapy a minimum of 6 weeks prior to study entry. * Willing and able to provide informed consent * All participants must be at least 21 years of age * Able to speak English Exclusion Criteria: * Patients who are pregnant * Patients who are unable to lie still * Patients who are unable tolerate pressure stimulator * Non-MRI compatible devices such as aneurysm clips, cardiac pacemakers or defibrillators, cochlear implants, hardware, or any other implants * Iron-based tattoos, pieces of metal (bullet, BB, shrapnel) close to or in an important organ (such as the eye), or other non-MRI compatible metal in the body
References
Publications (0)
Data not yet available
No reference posted for this study.