Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-03-03 @ 2:36 AM
Study NCT ID:
NCT02406105
Status:
UNKNOWN
Last Update Posted:
2015-04-02
First Post:
2015-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Effectiveness and Toxicity of CyberKnife Based Radiosurgery for Parkinson Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D014202', 'term': 'Tremor'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-01', 'studyFirstSubmitDate': '2015-02-22', 'studyFirstSubmitQcDate': '2015-04-01', 'lastUpdatePostDateStruct': {'date': '2015-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Tremor reduction evaluated using Unified Parkinson's Disease Rating Scale", 'timeFrame': '1 year', 'description': "Tremor reduction will be evaluated using Unified Parkinson's Disease Rating Scale (UDPRS)"}], 'secondaryOutcomes': [{'measure': 'Safety of treatment (evaluated using RTOG/EORTC Acute Radiation Morbidity Scoring Criteria and Late Radiation Morbidity Scoring Schema)', 'timeFrame': '1 year', 'description': 'Safety of treatment will be evaluated using RTOG/EORTC Acute Radiation Morbidity Scoring Criteria and Late Radiation Morbidity Scoring Schema'}, {'measure': 'Evaluation of the value of magnetic resonance spectroscopy as a tool for metabolites proportions changes after PD radiosurgery (spectra of metabolites in irradiated volume)', 'timeFrame': '2 years', 'description': 'None grading system of serial spectroscopy dedicated for such purpose exists. We will check spectra of metabolites in irradiated volume and proportions between them, trying to form conclusions considering necrosis/gliosis forming.'}, {'measure': 'Implementation of CyberKnife radiosurgery for Parkinson disease patients not eligible for other treatment modality', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tremor', 'Parkinson disease', 'functional radioablation', 'Cyber Knife radiosurgery'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '18334856', 'type': 'BACKGROUND', 'citation': 'Hooper AK, Okun MS, Foote KD, Fernandez HH, Jacobson C, Zeilman P, Romrell J, Rodriguez RL. Clinical cases where lesion therapy was chosen over deep brain stimulation. Stereotact Funct Neurosurg. 2008;86(3):147-52. doi: 10.1159/000120426. Epub 2008 Mar 12.'}, {'pmid': '10853075', 'type': 'BACKGROUND', 'citation': 'Niranjan A, Jawahar A, Kondziolka D, Lunsford LD. A comparison of surgical approaches for the management of tremor: radiofrequency thalamotomy, gamma knife thalamotomy and thalamic stimulation. Stereotact Funct Neurosurg. 1999;72(2-4):178-84. doi: 10.1159/000029723.'}, {'pmid': '9688111', 'type': 'BACKGROUND', 'citation': 'Young RF, Shumway-Cook A, Vermeulen SS, Grimm P, Blasko J, Posewitz A, Burkhart WA, Goiney RC. Gamma knife radiosurgery as a lesioning technique in movement disorder surgery. J Neurosurg. 1998 Aug;89(2):183-93. doi: 10.3171/jns.1998.89.2.0183.'}, {'pmid': '19291984', 'type': 'BACKGROUND', 'citation': 'Stancanello J, Romanelli P, Pantelis E, Sebastiano F, Modugno N. Atlas-based functional radiosurgery: early results. Med Phys. 2009 Feb;36(2):457-63. doi: 10.1118/1.3056460.'}, {'pmid': '14914373', 'type': 'BACKGROUND', 'citation': 'LEKSELL L. The stereotaxic method and radiosurgery of the brain. Acta Chir Scand. 1951 Dec 13;102(4):316-9. No abstract available.'}, {'pmid': '1725560', 'type': 'BACKGROUND', 'citation': 'Lindquist C, Kihlstrom L, Hellstrand E. Functional neurosurgery--a future for the gamma knife? Stereotact Funct Neurosurg. 1991;57(1-2):72-81. doi: 10.1159/000099557.'}, {'pmid': '9782254', 'type': 'BACKGROUND', 'citation': 'Young RF, Vermeulen S, Posewitz A, Shumway-Cook A. Pallidotomy with the gamma knife: a positive experience. Stereotact Funct Neurosurg. 1998 Oct;70 Suppl 1:218-28. doi: 10.1159/000056425.'}, {'pmid': '9609299', 'type': 'BACKGROUND', 'citation': 'Duma CM, Jacques DB, Kopyov OV, Mark RJ, Copcutt B, Farokhi HK. Gamma knife radiosurgery for thalamotomy in parkinsonian tremor: a five-year experience. J Neurosurg. 1998 Jun;88(6):1044-9. doi: 10.3171/jns.1998.88.6.1044.'}, {'pmid': '11143229', 'type': 'BACKGROUND', 'citation': 'Young RF, Jacques S, Mark R, Kopyov O, Copcutt B, Posewitz A, Li F. Gamma knife thalamotomy for treatment of tremor: long-term results. J Neurosurg. 2000 Dec;93 Suppl 3:128-35. doi: 10.3171/jns.2000.93.supplement.'}, {'pmid': '10932286', 'type': 'BACKGROUND', 'citation': 'Niranjan A, Kondziolka D, Baser S, Heyman R, Lunsford LD. Functional outcomes after gamma knife thalamotomy for essential tremor and MS-related tremor. Neurology. 2000 Aug 8;55(3):443-6. doi: 10.1212/wnl.55.3.443.'}, {'pmid': '11735773', 'type': 'BACKGROUND', 'citation': 'Okun MS, Stover NP, Subramanian T, Gearing M, Wainer BH, Holder CA, Watts RL, Juncos JL, Freeman A, Evatt ML, Schuele SU, Vitek JL, DeLong MR. Complications of gamma knife surgery for Parkinson disease. Arch Neurol. 2001 Dec;58(12):1995-2002. doi: 10.1001/archneur.58.12.1995.'}, {'pmid': '18081480', 'type': 'BACKGROUND', 'citation': 'Friehs GM, Park MC, Goldman MA, Zerris VA, Noren G, Sampath P. Stereotactic radiosurgery for functional disorders. Neurosurg Focus. 2007;23(6):E3. doi: 10.3171/FOC-07/12/E3.'}, {'pmid': '17317994', 'type': 'BACKGROUND', 'citation': 'Duma CM. Movement disorder radiosurgery--planning, physics and complication avoidance. Prog Neurol Surg. 2007;20:249-266. doi: 10.1159/000100168.'}, {'pmid': '18173319', 'type': 'BACKGROUND', 'citation': 'Kondziolka D, Ong JG, Lee JY, Moore RY, Flickinger JC, Lunsford LD. Gamma Knife thalamotomy for essential tremor. J Neurosurg. 2008 Jan;108(1):111-7. doi: 10.3171/JNS/2008/108/01/0111.'}, {'pmid': '19895197', 'type': 'BACKGROUND', 'citation': 'Young RF, Li F, Vermeulen S, Meier R. Gamma Knife thalamotomy for treatment of essential tremor: long-term results. J Neurosurg. 2010 Jun;112(6):1311-7. doi: 10.3171/2009.10.JNS09332.'}, {'pmid': '21904267', 'type': 'BACKGROUND', 'citation': 'Ohye C, Higuchi Y, Shibazaki T, Hashimoto T, Koyama T, Hirai T, Matsuda S, Serizawa T, Hori T, Hayashi M, Ochiai T, Samura H, Yamashiro K. Gamma knife thalamotomy for Parkinson disease and essential tremor: a prospective multicenter study. Neurosurgery. 2012 Mar;70(3):526-35; discussion 535-6. doi: 10.1227/NEU.0b013e3182350893.'}, {'pmid': '20457958', 'type': 'BACKGROUND', 'citation': 'Lim SY, Hodaie M, Fallis M, Poon YY, Mazzella F, Moro E. Gamma knife thalamotomy for disabling tremor: a blinded evaluation. Arch Neurol. 2010 May;67(5):584-8. doi: 10.1001/archneurol.2010.69.'}, {'pmid': '21336920', 'type': 'BACKGROUND', 'citation': 'Franzini A, Marchetti M, Brait L, Milanesi I, Messina G, Forapani E, Broggi G, Fariselli L. Deep brain stimulation and frameless stereotactic radiosurgery in the treatment of bilateral parkinsonian tremor: target selection and case report of two patients. Acta Neurochir (Wien). 2011 May;153(5):1069-75. doi: 10.1007/s00701-011-0962-0. Epub 2011 Feb 20.'}, {'pmid': '15509320', 'type': 'BACKGROUND', 'citation': 'Yu C, Main W, Taylor D, Kuduvalli G, Apuzzo ML, Adler JR Jr. An anthropomorphic phantom study of the accuracy of Cyberknife spinal radiosurgery. Neurosurgery. 2004 Nov;55(5):1138-49. doi: 10.1227/01.neu.0000141080.54647.11.'}]}, 'descriptionModule': {'briefSummary': 'Clinical objective of the study is estimation of effectiveness and safety of Cyber Knife based functional radiosurgery for Parkinson disease patients suffering from tremor.', 'detailedDescription': "Basic treatment patients with Parkinson's disease (PD - Parkinson's disease) or essential tremor (ET - essential tremor) is a pharmacotherapy. In the case of lack of its effectiveness, the gold standard procedure is deep brain stimulation (DBS). Despite the proven efficacy, still remains a group of patients not eligible for this treatment. in such cases, ablation within the deep structures of the brain (thalamotomy, subthalamotomy, pallidotomy) can be considered.\n\nThermoablation and radiosurgery (SRS - Stereotactic radiosurgery) are used: SRS is prefered for patients who are not candidates for invasive procedures.\n\n27 patients will be enrolled in this study. All patients will be immobilized in thermoplastic masks and planned (RT) on the base of CT/MRI fusion.\n\nThe initial total dose in the target volume (thalamic nuclei complex - VoP and VoA ) will be 70 Gy given in one fraction. The dose will be escalated every 5 Gy and the treatment effect and possible side effects will be evaluated. Dose escalation will be finished at a dose at which the effect of treatment will be satisfactory, or if side effects are unacceptable. The highest dose tested dose will be 110 Gy. Three patients will be irradiated with particular doses and observed at least 3 moths; then study will be continued.\n\nPatients will be controlled 3, 6, 9, 12, 18 months after treatment completion and, next every each 6 months. Neurologic and neuropsychologic status, local effect (MRI ) and eventual toxicity will be checked during follow-up (FU)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Idiopatic Parkinson Disease (PD)\n* Lack of effective pharmacotherapy\n* Lack of possibilities of qualifications to DBS (deep brain stimulation) procedure\n* Informed consent for participation in the study and for radiotherapy\n\nExclusion Criteria:\n\n* Age under 18\n* Pregnancy\n* Other than PD induced tremor\n* Dementia, psychosis.\n* Poor performance status\n* Atrophic cerebral changes, structural changes in basal nuclei\n* Lack of informed consent.'}, 'identificationModule': {'nctId': 'NCT02406105', 'briefTitle': 'An Effectiveness and Toxicity of CyberKnife Based Radiosurgery for Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'Maria Sklodowska-Curie National Research Institute of Oncology'}, 'officialTitle': 'An Evaluation of Effectiveness and Toxicity of CyberKnife Based Functional Radiosurgery for Parkinson Disease Patients Suffering From Tremor and Its Implementation in Poland', 'orgStudyIdInfo': {'id': 'FSRSPD-COI-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiosurgical thalamotomy', 'description': 'Cyber Knife based functional radiosurgical thalamotomy, photons 6MV, single dose 70-110 Gy', 'interventionNames': ['Radiation: Radiosurgical thalamotomy', 'Drug: CyberKnife']}], 'interventions': [{'name': 'Radiosurgical thalamotomy', 'type': 'RADIATION', 'description': 'Cybernetic microradiosurgery based thalamotomy', 'armGroupLabels': ['Radiosurgical thalamotomy']}, {'name': 'CyberKnife', 'type': 'DRUG', 'armGroupLabels': ['Radiosurgical thalamotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44-100', 'city': 'Gliwice', 'state': 'Wybrzeze AK 15', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Leszek Miszczyk, MD. PhD', 'role': 'CONTACT', 'email': 'leszek@io.gliwice.pl', 'phone': '+48322788001'}, {'name': 'Leszek Miszczyk, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Grzegorz Wozniak, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Agata Roch-Zniszczol, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dawid Larysz, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lukasz Zarudzki, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Malgorzata Fudzinska', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Agnieszka Rozek', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch', 'geoPoint': {'lat': 50.29761, 'lon': 18.67658}}], 'centralContacts': [{'name': 'Leszek Miszczyk, MD, PhD', 'role': 'CONTACT', 'email': 'leszek@io.gliwice.pl', 'phone': '0048322788001'}], 'overallOfficials': [{'name': 'Leszek Miszczyk, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Sklodowska-Curie National Research Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}