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

NCT06488651 | Completed

• 2 other identifiers: METc 2022/39211036
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplantation; Tremor

Keywords

Kidney transplant recipient; Tremor; Calcineurin inhibitor; Tacrolimus; Cyclosporine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The visual analog scale (VAS)

  From enrollment, before transplantation, to one year after transplantation

• Accelerometery

  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

  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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospitalized (future) kidney and lung transplant recipients

You may qualify if:

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

You may not qualify if:

• patients who are unable to comprehend the questionnaires and tests

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location

Related Publications (8)

• Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. FK506 Kidney Transplant Study Group. Transplantation. 1997 Apr 15;63(7):977-83. doi: 10.1097/00007890-199704150-00013.

  PMID: 9112351 BACKGROUND

• David-Neto E, Lemos FBC, Arai Furusawa E, Schwartzman BS, Cavalcante JS, Yagyu EM, Romano P, Ianhez LE. Impact of cyclosporin A pharmacokinetics on the presence of side effects in pediatric renal transplantation. J Am Soc Nephrol. 2000 Feb;11(2):343-349. doi: 10.1681/ASN.V112343.

  PMID: 10665942 BACKGROUND

• Erro R, Bacchin R, Magrinelli F, Tomei P, Geroin C, Squintani G, Lupo A, Zaza G, Tinazzi M. Tremor induced by Calcineurin inhibitor immunosuppression: a single-centre observational study in kidney transplanted patients. J Neurol. 2018 Jul;265(7):1676-1683. doi: 10.1007/s00415-018-8904-x. Epub 2018 May 18.

  PMID: 29777361 BACKGROUND

• Paul F, Muller J, Christe W, Steinmuller T, Poewe W, Wissel J. Postural hand tremor before and following liver transplantation and immunosuppression with cyclosporine or tacrolimus in patients without clinical signs of hepatic encephalopathy. Clin Transplant. 2004 Aug;18(4):429-33. doi: 10.1111/j.1399-0012.2004.00184.x.

  PMID: 15233821 BACKGROUND

• Morgan JC, Kurek JA, Davis JL, Sethi KD. Insights into Pathophysiology from Medication-induced Tremor. Tremor Other Hyperkinet Mov (N Y). 2017 Nov 22;7:442. doi: 10.7916/D8FJ2V9Q. eCollection 2017.

  PMID: 29204312 BACKGROUND

• 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.

  PMID: 29193359 BACKGROUND

• Naesens M, Kuypers DR, Sarwal M. Calcineurin inhibitor nephrotoxicity. Clin J Am Soc Nephrol. 2009 Feb;4(2):481-508. doi: 10.2215/CJN.04800908.

  PMID: 19218475 BACKGROUND

• Kugler C, Fischer S, Gottlieb J, Tegtbur U, Welte T, Goerler H, Simon A, Haverich A, Strueber M. Symptom experience after lung transplantation: impact on quality of life and adherence. Clin Transplant. 2007 Sep-Oct;21(5):590-6. doi: 10.1111/j.1399-0012.2007.00693.x.

  PMID: 17845632 BACKGROUND

MeSH Terms

Conditions

Tremor

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: July 5, 2024
• Study Start: August 17, 2022
• Primary Completion: September 12, 2025
• Study Completion: September 12, 2025
• Last Updated: September 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)