Pilot Study for the Use of Spinal Cord Stimulation to Alleviate Pain from Chemotherapy Induced Peripheral Neuropathy Due to Taxane or Platinum Based Agents

University of Maryland St. Joseph Medical Center0 个研究点目标入组 10 人开始时间: 2024年9月15日最近更新: 2024年9月19日

适应症

试验速览

阶段: 4 期
状态: 尚未招募
发起方: University of Maryland St. Joseph Medical Center
入组人数: 10
主要终点: -- Measure response of CIPN pain to HF10 treatment using the numeric scale of pain (NRS) at SCS trial for all subjects and at 3, 6 and 12 months after implant for subjects who qualify for permanent implant.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord will be a safe and effective treatment for CIPN, reducing pain in the lower extremities by at least 50%.

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

•CIPN as diagnosed by Oncology and/or neurology
•Receipt of a platinum-based or taxane chemotherapy prior to development of CIPN
•Pain severity greater than 4 out of 10 on a numeric rating scale of pain
•Pain chronicity greater than 6 months after the cessation of chemotherapy
•Failure of medical therapy, which must have included duloxetine
•Age 18 or greater

排除标准

•Platelet count less than 100k/mm3
•Spinal anatomy precluding placement of the SCS leads between T6 and T11
•Active infection
•Estimated Lifespan less than 1 year
•Receipt of vincristine, thalidomide, bortezomib, or eribulin within the prior 12 months

结局指标

主要结局

-- Measure response of CIPN pain to HF10 treatment using the numeric scale of pain (NRS) at SCS trial for all subjects and at 3, 6 and 12 months after implant for subjects who qualify for permanent implant.

时间窗: 1 year

次要结局

- - Neuropathy symptoms will be quantified using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale (CIPN20). CIPN20 is a 20-item patient questionnaire with items scored 1 to 4.(1 year)
- Pain interference in daily life will be quantified via the brief pain inventory (BPI).(1 year)
- Neuropathy findings will be quantified with the modified Toronto clinical neuropathy score (mTCNS).(1 year)
- The subject's impression of SCS efficacy will be measured using the patient global impression of change (PGIC).(1 year)
- Health related quality of life will be assessed using the EuroQOL5D-5L questionnaire.(1 year)
- Any treatment related adverse events observed during the trial will be documented using the Common Terminology Criteria for Adverse Events (CTCAE) ver 5.0.(1 year)

研究者

发起方

University of Maryland St. Joseph Medical Center

申办方类型

Other

责任方

Sponsor

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