Pituitary Gland Stimulation for Cancer Pain Relief (PGS)

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    10
  • sponsor
    Leiden University Medical Center
Updated on 22 March 2022
cancer
pain relief
cancer pain
pain relieving

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.

Details
Condition Oncology Pain
Treatment Pituitary gland stimulation
Clinical Study IdentifierNCT05230238
SponsorLeiden University Medical Center
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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