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Pituitary Gland Stimulation for pain relief

Pituitary Gland Stimulation for pain relief - PGS for pain relief

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52130
Enrollment
10
Registered
2021-08-30
Start date
2021-10-12
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oncogene pijn, centrale neuropathische pijn intractable pain severe pain

Interventions

Patients will undergo an implantation of an extradural pituitary surface electrode in the posterior pituitary fossa. The electrode will be attached to a neurostimulator via which the patient can giv

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: two patient categories are studied, with each their own set of inclusion criteria set one: - Adult patient - In palliative phase of metastatic disease - Inadequately controlled pain with standard care - Karnofsky Performance Score >=50 set two: - Adult patient - Diagnosed with central neuropathic pain - Inadequately controlled pain with standard care

Exclusion criteria

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 • Immunodeficiency • Need for anticoagulation therapy that cannot be abrogated for surgery • 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

MeasureTime frame
Pain, defined as continuous or background pain, measured via a Numeric Rating Scale and on the Brief Pain Inventory, corrected for medication use Patient satisfaction with treatment Treatment safety in terms of side effects

Secondary

MeasureTime frame
Use of analgetic medication Hormone levels Patient-reported outcome measures: pain interference, social role functioning, cognitive functioning

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)