Determination of central pain modulation biomarkers to characterize and profile cancer patients with refractory pain and adaptation and validation of a home-based transcranial brain stimulation procedure for their palliative care
- Conditions
- C00-C97Malignant neoplasms
- Registration Number
- DRKS00031070
- Lead Sponsor
- niversitätsmedizin Göttingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 450
Adult subjects = 18 years old.
-Able to provide informed consent to participate in the study.
-Able to self-report pain.
-To have a diagnosis of cancer affecting lung, breast, pancreas or colon (with metastases or not).
-The life expectancy of at least six months.
-Cancer pain persisting despite best tolerated pharmacological treatment
-Pain rated >= 5 on a 0-10 Numeric Rating Scale (NRS) persisting for over 1 month prior to enrolment.
-Ability to use internet and WhatsApp or have a person (relative, caregiver) to help them.
-Pregnant women or women of fertile age that did not have efficacious contraception during the whole period of the study.
-Neurological or psychiatric diseases (except anxiety or depression)
-Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
-History of neurosurgery, traumatic brain injury with loss of consciousness, and/or cortical lesions
-Present risk factors for receiving tES (e.g., history of epilepsy, metal devices in the brain, etc.).
-History of non-malignant chronic pain.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umeric rating scale of the intensity of pain
- Secondary Outcome Measures
Name Time Method -Use of analgesic medication (type and dose)<br>-NRS of unpleasantness of pain<br>-NRS of interference due to pain<br>-NRS of fatigue