Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy
Milan, 20133, Italy
NCT Number: NCT02095600
Stereotactic lesioning of thalamus and basal ganglia for treatment of tremor is a well-known procedure which, prior to the introduction of deep brain stimulation, or DBS, was usually achieved using stereotactic surgical procedures.
Radiosurgery of invisible targets to treat movement disorders and intractable pain are still the domain of frame-based procedures, due to the need of a solid reference system registered to the anterior commissure-posterior commissure (AC-PC) line, which allows the use of stereotactic atlases.
In this study we want to utilize a mathematical method that uses atlas-derived stereotactic coordinates to perform frameless images-guided radiosurgery of such functional targets Particularly the aim of the present study is to investigate both the efficacy and the safety of the methodology to treat upper limb and hand tremor in elderly or in patients which are not ot susceptible of surgical procedures. For these reasons a dose escalation prospective trial have been designed.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Milan, 20133, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 years
Tremor control (improvement in Fahn Tolosa Marin Tremor Rating Scale, FTMTRS, and/or Unified Parkinson's Disease Rating Scale, UPDRS, motor)
Time frame: 2 years
Time frame: 2 years
The treatment safety will be evaluated. Toxicity will be registered according to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 3,NCI-CTCAE v3.
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Other
Deep Brain Stimulation and Frameless Stereotactic Radiosurgery in the Treatment of Drug Resistant Invalidating Tremor
Acronym: DB-SRS
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