Clinical trial NCT06488651: Trajectory of Immunosuppression-Caused Tremor In Kidney Transplant Recipients
Official title: Trajectory of Immunosuppression-Caused Tremor In Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplantation
Tremor
Keywords: Kidney transplant recipient
Tremor
Calcineurin inhibitor
Tacrolimus
Cyclosporine
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At time of screening, patients will be hospitalized because of the planned kidney transplantation. All patients who will receive a kidney transplant are eligible for study participation.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 16 years old, who will receive a kidney transplant

Exclusion Criteria:

* patients who are unable to comprehend the questionnaires and tests

Primary outcomes:
measure: Bain spirographs
timeFrame: From enrollment, before transplantation, to one year after transplantation
Secondary outcomes:
measure: The visual analog scale (VAS)
timeFrame: From enrollment, before transplantation, to one year after transplantation
measure: Accelerometery
timeFrame: Measurement will be performed for the duration of one day, at a non-specific time-point after transplantation.
measure: The Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) part B
timeFrame: From enrollment, before transplantation, to one year after transplantation
measure: The Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) part C
timeFrame: From enrollment, before transplantation, to one year after transplantation
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
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citation: Bhatia KP, Bain P, Bajaj N, Elble RJ, Hallett M, Louis ED, Raethjen J, Stamelou M, Testa CM, Deuschl G; Tremor Task Force of the International Parkinson and Movement Disorder Society. Consensus Statement on the classification of tremors. from the task force on tremor of the International Parkinson and Movement Disorder Society. Mov Disord. 2018 Jan;33(1):75-87. doi: 10.1002/mds.27121. Epub 2017 Nov 30.
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