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An Effectiveness and Toxicity of CyberKnife Based Radiosurgery for Parkinson Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02406105
Recruitment Status : Recruiting
First Posted : April 2, 2015
Last Update Posted : April 2, 2015
Sponsor:
Information provided by (Responsible Party):
Maria Sklodowska-Curie Institute - Oncology Center

Brief Summary:
Clinical objective of the study is estimation of effectiveness and safety of Cyber Knife based functional radiosurgery for Parkinson disease patients suffering from tremor.

Condition or disease Intervention/treatment Phase
Parkinson Disease Radiation: Radiosurgical thalamotomy Drug: CyberKnife Phase 2

Detailed Description:

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.

Thermoablation and radiosurgery (SRS - Stereotactic radiosurgery) are used: SRS is prefered for patients who are not candidates for invasive procedures.

27 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.

The 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.

Patients 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of Effectiveness and Toxicity of CyberKnife Based Functional Radiosurgery for Parkinson Disease Patients Suffering From Tremor and Its Implementation in Poland
Study Start Date : January 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radiosurgical thalamotomy
Cyber Knife based functional radiosurgical thalamotomy, photons 6MV, single dose 70-110 Gy
Radiation: Radiosurgical thalamotomy
Cybernetic microradiosurgery based thalamotomy

Drug: CyberKnife



Primary Outcome Measures :
  1. Tremor reduction evaluated using Unified Parkinson's Disease Rating Scale [ Time Frame: 1 year ]
    Tremor reduction will be evaluated using Unified Parkinson's Disease Rating Scale (UDPRS)


Secondary Outcome Measures :
  1. Safety of treatment (evaluated using RTOG/EORTC Acute Radiation Morbidity Scoring Criteria and Late Radiation Morbidity Scoring Schema) [ Time Frame: 1 year ]
    Safety of treatment will be evaluated using RTOG/EORTC Acute Radiation Morbidity Scoring Criteria and Late Radiation Morbidity Scoring Schema

  2. Evaluation of the value of magnetic resonance spectroscopy as a tool for metabolites proportions changes after PD radiosurgery (spectra of metabolites in irradiated volume) [ Time Frame: 2 years ]
    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.

  3. Implementation of CyberKnife radiosurgery for Parkinson disease patients not eligible for other treatment modality [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopatic Parkinson Disease (PD)
  • Lack of effective pharmacotherapy
  • Lack of possibilities of qualifications to DBS (deep brain stimulation) procedure
  • Informed consent for participation in the study and for radiotherapy

Exclusion Criteria:

  • Age under 18
  • Pregnancy
  • Other than PD induced tremor
  • Dementia, psychosis.
  • Poor performance status
  • Atrophic cerebral changes, structural changes in basal nuclei
  • Lack of informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406105


Contacts
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Contact: Leszek Miszczyk, MD, PhD 0048322788001 leszek@io.gliwice.pl

Locations
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Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch Recruiting
Gliwice, Wybrzeze AK 15, Poland, 44-100
Contact: Leszek Miszczyk, MD. PhD    +48322788001    leszek@io.gliwice.pl   
Principal Investigator: Leszek Miszczyk, MD, PhD         
Sub-Investigator: Grzegorz Wozniak, MD PhD         
Sub-Investigator: Agata Roch-Zniszczol, MD         
Sub-Investigator: Dawid Larysz, MD, PhD         
Sub-Investigator: Lukasz Zarudzki, MD         
Sub-Investigator: Malgorzata Fudzinska         
Sub-Investigator: Agnieszka Rozek         
Sponsors and Collaborators
Maria Sklodowska-Curie Institute - Oncology Center
Investigators
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Study Director: Leszek Miszczyk, MD, PhD Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland

Publications:

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Responsible Party: Maria Sklodowska-Curie Institute - Oncology Center
ClinicalTrials.gov Identifier: NCT02406105    
Other Study ID Numbers: FSRSPD-COI-03
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: April 2, 2015
Last Verified: March 2015
Keywords provided by Maria Sklodowska-Curie Institute - Oncology Center:
tremor
Parkinson disease
functional radioablation
Cyber Knife radiosurgery
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases