Pituitary Gland Stimulation for Cancer Pain Relief

NCT ID: NCT05230238

Last Updated: 2023-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-12

Study Completion Date

2024-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Oncology Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pituitary stimulation

Patients will receive pituitary stimulation as oncology pain treatment.

Group Type EXPERIMENTAL

Pituitary gland stimulation

Intervention Type DEVICE

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

Interventions

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Pituitary gland stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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wrvanfurth

neurosurgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wouter van Furth, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Leiden University Medical Center

Leiden, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Wouter van Furth, MD, Phd

Role: CONTACT

+31715162109

Facility Contacts

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Wouter van Furth, MD, PhD

Role: primary

Other Identifiers

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P21.036

Identifier Type: -

Identifier Source: org_study_id

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