Deep Brain Frameless Radiosurgery for Drug Resistant Invalidating Tremor. Dose Escalation Pilot Study (PRDBRS2)
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|ClinicalTrials.gov Identifier: NCT02585583|
Recruitment Status : Recruiting
First Posted : October 23, 2015
Last Update Posted : February 12, 2020
The gamma knife radiosurgical thalamotomy to treat many movement disorders is recently becoming a new and well defined treatment paradigm.
The CyberKnife if compared to the frame-based radiosurgery, is a pain free procedure which offers the advantage of a better patient's compliance by avoiding local anaesthesia and the discomfort due to wearing the frame for the period of time needed for the whole procedure.
Unfortunately the subtle but substantial differences about the 3D dose distribution and the dose fall-off features between GK and CK made mandatory investigations about the effectiveness and the safety when the cyberknife is used.
Particularly the minimum effective and safety dose have to be defined yet A previous study (NCT02095600) failed in demonstrating the efficacy of 75 Gy, 80 Gy, 90 Gy.
The aim of the present study is to investigate about the effectiveness of 100 Gy, 120 Gy, 130 Gy and 140 Gy.
The safety and the targeting methodology will be also in investigated.
|Condition or disease||Intervention/treatment||Phase|
|Tremor, Limb||Radiation: Thalamotomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Deep Brain Frameless Radiosurgery for Drug Resistant Invalidating Tremor. Dose Escalation Pilot Study|
|Actual Study Start Date :||May 2015|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Patients will undergo to radiosurgical thalamotomy by Cyberknife system.
VoA-Vop complex of the thalamous or VIM nucleus will be targeted. 100 Gy, 120 Gy, 130 Gy, 140 Gy will be the foreseen prescription dose. CyberKnife will be always used to perform the procedure.
- Minimun effective dose (presence/absence of visible MRI thalamotomy) [ Time Frame: 18 months ]The aim of this study is to define the minimum effective dose to obtain a tremor control
- Targeting validation (post treatment thalamotomy merge the target plan) [ Time Frame: 18 months ]Targeting methodology validation (the lesions position, if present, will be compared to the treatment plan target position, deviations will be registered).
- Toxicity (according to NCI CTCAE v4.0) [ Time Frame: 24 months ]Number and grade of adverse events
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): NCT02585583
|Contact: Marcello Marchetti, MD||+39022394 ext email@example.com|
|Principal Investigator:||Marcello Marchetti, MD||Fondazione Irccs Istituto Neurologico Carlo Besta|