Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-01 @ 6:27 AM
Study NCT ID:
NCT06488651
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2024-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trajectory of Immunosuppression-Caused Tremor In Kidney and Lung Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014202', 'term': 'Tremor'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2024-06-11', 'studyFirstSubmitQcDate': '2024-07-03', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bain spirographs', 'timeFrame': 'From enrollment, before transplantation, to one year after transplantation', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The visual analog scale (VAS)', 'timeFrame': 'From enrollment, before transplantation, to one year after transplantation', 'description': 'A scale from 0 (no tremor) to 100 (most severe tremor)'}, {'measure': 'Accelerometery', 'timeFrame': 'Measurement will be performed for the duration of one day, at a non-specific time-point after transplantation.', 'description': '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.'}, {'measure': 'The Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) part B', 'timeFrame': 'From enrollment, before transplantation, to one year after transplantation', 'description': '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).'}, {'measure': 'The Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) part C', 'timeFrame': 'From enrollment, before transplantation, to one year after transplantation', 'description': '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).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney transplant recipient', 'Tremor', 'Calcineurin inhibitor', 'Tacrolimus', 'Cyclosporine'], 'conditions': ['Kidney Transplantation', 'Tremor']}, 'referencesModule': {'references': [{'pmid': '9112351', 'type': 'BACKGROUND', 'citation': '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': '10665942', 'type': 'BACKGROUND', 'citation': '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': '29777361', 'type': 'BACKGROUND', 'citation': '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': '15233821', 'type': 'BACKGROUND', 'citation': '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': '29204312', 'type': 'BACKGROUND', 'citation': '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': '29193359', 'type': 'BACKGROUND', '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.'}, {'pmid': '19218475', 'type': 'BACKGROUND', 'citation': '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': '17845632', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hospitalized (future) kidney and lung transplant recipients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 16 years old, who will receive a kidney transplant or have recieved a kidney or lung transplant\n\nExclusion Criteria:\n\n* patients who are unable to comprehend the questionnaires and tests'}, 'identificationModule': {'nctId': 'NCT06488651', 'acronym': 'TICTIK', 'briefTitle': 'Trajectory of Immunosuppression-Caused Tremor In Kidney and Lung Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Trajectory of Immunosuppression-Caused Tremor In Kidney and Lung Transplant Recipients', 'orgStudyIdInfo': {'id': 'METc 2022/392'}, 'secondaryIdInfos': [{'id': '11036', 'type': 'REGISTRY', 'domain': 'UMCG Research Registry'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713GZ', 'city': 'Groningen', 'state': 'Provincie Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}