NCT05230238

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

January 13, 2022

Last Update Submit

March 9, 2023

Conditions

Oncology Pain

Outcome Measures

Primary Outcomes (2)

  • Perceived pain

    Numeric Rating Scale (0= no pain, 10=most severe pain)

    4 months

  • Pain Medication

    Morphine Equivalent Doses for background and escape medication

    4 months

Study Arms (1)

pituitary stimulation

EXPERIMENTAL

Patients will receive pituitary stimulation as oncology pain treatment.

Device: Pituitary gland stimulation

Interventions

Pituitary gland stimulationDEVICE

Pituitary gland stimulation via an surface electrode connected to an external neurostimulator

pituitary stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, Netherlands

RECRUITING

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wouter van Furth, MD, PhD

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wouter van Furth, MD, Phd

CONTACT

+31715162109w.r.van_furth@lumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
neurosurgeon

Study Record Dates

First Submitted

January 13, 2022

First Posted

February 8, 2022

Study Start

October 12, 2021

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations

NL(1)