Trajectory of Immunosuppression-Caused Tremor In Kidney Transplant Recipients

Recruiting

• Conditions: Kidney Transplantation; Tremor

• Registration Number: NCT06488651
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-17
• Study First Submitted: 2024-06-11
• Status Verified: 2024-07
• Primary Completion: 2024-07
• Study Completion: 2024-07
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• patients who are unable to comprehend the questionnaires and tests

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bain spirographs	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.

Secondary Outcome Measures

Name	Time	Method
Accelerometery	Measurement will be performed for the duration of one day, at a non-specific time-point after transplantation.	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.
The visual analog scale (VAS)	From enrollment, before transplantation, to one year after transplantation	A scale from 0 (no tremor) to 100 (most severe tremor)
The Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) part C	From enrollment, before transplantation, to one year after transplantation	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).
The Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) part B	From enrollment, before transplantation, to one year after transplantation	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).

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands