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临床试验/NCT06488651
NCT06488651已完成不适用

Trajectory of Immunosuppression-Caused Tremor In Kidney and Lung Transplant Recipients

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Bain spirographs

研究概览

简要总结

Kidney and lung transplant recipients have to adhere to a strict immunosuppressive maintenance regime, generally consisting of calcineurin inhibitors (CNI). Tremor is a common and distressing side effect of CNI-use. To what extent objective and/or subjective tremor changes over time in currently unknown. Therefore, this longitudinal prospective study aimed to assess the course of tremor in the first year after transplantation.

详细描述

Kidney and lung transplant recipients have to adhere to a strict immunosuppressive maintenance regime, generally including calcineurin inhibitors (CNIs). These CNIs, including cyclosporine and tacrolimus, are essential to prevent graft rejection, but are associated with multiple side-effects. One of the most frequently reported side-effects of CNIs is the development of tremor: rhythmic, sinusoidal oscillations of the limbs, head or trunk. CNI-induced tremor generally occurs soon after initiation of CNI maintenance therapy, and occurs in up to half of kidney transplant recipients who use CNIs. Higher tacrolimus blood concentration has been associated with more severe tremor, and lung transplant recipients have the highest target trough concentration. Thus, tremor may be especially an import symptom for this patient population. To what extent tremor changes over time and whether this change is objective and/or subjective is currently unknown. In-depth investigation of the course of tremor is therefore warranted, which would add valuable information to previous studies on tremor prevalence. We therefore aim to assess the course of tremor in the first year after kidney- and lung transplantation. We expect tremor to become less severe over time after transplantation, because patients CNI dosage decrease with time after transplantation. However, it may also be hypothesized that CNI neurotoxicity may accumulate with consequent worsening of tremor. More information regarding the course of tremor after transplantation is essential to increase understanding of CNI-induced tremor, as well as for patient counselling and future research to alleviate the burden of CNI-induced tremor.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥ 16 years old, who will receive a kidney transplant or have recieved a kidney or lung transplant

排除标准

  • patients who are unable to comprehend the questionnaires and tests

结局指标

主要结局

Bain spirographs

时间窗: From enrollment, before transplantation, to one year after transplantation

Objective measurement of tremor severity. Spirographs will be assessed blindly by two neurologists, resulting in a score ranging from 0 (best outcome) to 10 (worst outcome) on each spiral.

次要结局

  • Accelerometery(Measurement will be performed for the duration of one day, at a non-specific time-point after transplantation.)
  • The visual analog scale (VAS)(From enrollment, before transplantation, to one year after transplantation)
  • The Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) part C(From enrollment, before transplantation, to one year after transplantation)
  • The Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) part B(From enrollment, before transplantation, to one year after transplantation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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