NCT05230238招募中不适用
Pituitary Gland Stimulation for Cancer Pain Relief
Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年10月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pain Medication
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Pain Medication
时间窗: 4 months
Morphine Equivalent Doses for background and escape medication
Perceived pain
时间窗: 4 months
Numeric Rating Scale (0= no pain, 10=most severe pain)
次要结局
未报告次要终点
研究者
wrvanfurth
neurosurgeon
Leiden University Medical Center
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Pituitary Gland Stimulation for pain reliefNL-OMON52130eids Universitair Medisch Centrum10
招募中
不适用
Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal SurgeryPituitary NeoplasmNCT03678389National Institute of Neurological Disorders and Stroke (NINDS)70
招募中
不适用
Application Research on Endoscopic Pseudocapsule-Based Resection for Pituitary AdenomasPituitary AdenomaNCT05466357Affiliated Hospital of Nantong University30
终止
2 期
Adductor Canal BlockTotal Knee ReplacementOsteoarthritisNCT04513145OrthoCarolina Research Institute, Inc.93
已完成
不适用
Place of Intrathecal Analgesia to Improve the Quality of Life of Painful Cancer PatientsInjections, SpinalCancerNCT04388449Institut Cancerologie de l'Ouest24