Trajectory of Immunosuppression-Caused Tremor In Kidney Transplant Recipients
NCT Number: NCT06488651
Acronym: TICTIK
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Kidney Transplantation|Tremor
Sponsor: University Medical Center Groningen
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-08-17
Completion Date: 2024-07
Locations: University Medical Center Groningen, Groningen, 9713GZ, Netherlands

Summary:
Kidney transplant recipients (KTR) 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 KTR using CNIs. 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.

The investigators aim to assess the course of tremor among KTR. The hypothesis is that tremor becomes less severe over time after transplantation, because CNI dosage decreases 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.

Primary Outcome Measures: Bain spirographs, 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., From enrollment, before transplantation, to one year after transplantation
Secondary Outcome Measures: The visual analog scale (VAS), A scale from 0 (no tremor) to 100 (most severe tremor), From enrollment, before transplantation, to one year after transplantation|Accelerometery, Patients with evident tremor will be invited to briefly (1 minute) wear an wrist accelerometer hourly for one day (9:00-21:00). This accelerometer, which is similar to a watch, allows us to assess tremor variability during the day., Measurement will be performed for the duration of one day, at a non-specific time-point after transplantation.|The Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) part B, The TRS-B relates to action tremors of the upper extremities, particulary writing and pouring liquids. Severity is determined by watching the patient carry out the aforementioned activities, after wich a score is derived that ranges from 0 points (no tremor) to 36 points (most severe tremor)., From enrollment, before transplantation, to one year after transplantation|The Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) part C, The TRS-C consists of eight questions to assess patient-perceived tremor occurrence during ADL, including writing, speaking, and bringing food or liquids to the mouth. To every question, patients graded the impairment tremor has on ADL with a score ranging from 0 (no influence of tremor on ADL) to 4 (severe influence of tremor on ADL). A total score was calculated by summing the individual scores, with a theoretical minimum score of 0 (no tremor) and a maximum score of 32 points (most severe tremor)., From enrollment, before transplantation, to one year after transplantation