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Deep Brain Frameless Radiosurgery for Drug Resistant Invalidating Tremor. Dose Escalation Pilot Study (PRDBRS2)

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. Identifier: NCT02585583
Recruitment Status : Recruiting
First Posted : October 23, 2015
Last Update Posted : February 12, 2020
Information provided by (Responsible Party):
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Radiosurgical thalamotomy
Patients will undergo to radiosurgical thalamotomy by Cyberknife system.
Radiation: Thalamotomy
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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).

  2. Toxicity (according to NCI CTCAE v4.0) [ Time Frame: 24 months ]
    Number and grade of adverse events

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

Inclusion Criteria:

  • Patients affected by severe upper limb tremor refractory to medical therapy and who are less than optimal candidate for a deep brain stimulation (DBS) procedure.
  • Age ≥ 18 years old
  • Refusal of DBS procedure
  • Written consent

Exclusion Criteria:

  • Pregnancy
  • CT/MRI contraindication
  • Illiteracy

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 identifier (NCT number): NCT02585583

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Contact: Marcello Marchetti, MD +39022394 ext 2157

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Radiotherapy Unit Recruiting
Milan, Italy, 20133
Contact: Marcello Marchetti, MD    022394 ext 2157   
Contact: Laura Fariselli, MD    022394 ext 2157   
Sponsors and Collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
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Principal Investigator: Marcello Marchetti, MD Fondazione Irccs Istituto Neurologico Carlo Besta
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Responsible Party: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Identifier: NCT02585583    
Other Study ID Numbers: PR DB RS2
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Keywords provided by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta:
Deep Brain
Essential tremor
Parkinson Disease
deep brain stimulation
intractable, drug resistant, invalidating tremor
Additional relevant MeSH terms:
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Neurologic Manifestations
Nervous System Diseases