Oncology Pain
Conditions
Brief summary
Patients will undergo an implantation of an extradural pituitary surface electrode in the pituitary fossa. The electrode will be attached to a neurostimulator via which the patient will receive up to 8 (patient requested) stimulations per day.
Interventions
DEVICEPituitary gland stimulation
Pituitary gland stimulation via an surface electrode connected to an external neurostimulator
Sponsors
Leiden University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient * In palliative phase of metastatic disease, without options for further systemic treatment or radiotherapy * Inadequately controlled pain with standard care * Most prominent part of experienced pain is nociceptive * Karnofsky Performance Score ≥30
Exclusion criteria
* Not fit for general anesthesia * Pregnancy * Unfavorable local anatomy for PGS, due to a disease process, or anatomical configuration * Clinical signs of posterior pituitary gland disfunction * Recent history of alcohol or drug abuse * Severe immunodeficiency * Need for anticoagulation therapy that cannot be abrogated for surgery * Need for subsequent MRI-imaging * Cognitive impairments prohibiting full understanding of study and ability to provide informed consent * Not able to adequately communicate in Dutch or English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived pain | 4 months | Numeric Rating Scale (0= no pain, 10=most severe pain) |
| Pain Medication | 4 months | Morphine Equivalent Doses for background and escape medication |
Countries
Netherlands
Contacts
Primary ContactWouter van Furth, MD, Phd
Outcome results
None listed