Radiosurgery for Drug Resistant Invalidating Tremor (DB-SRS)
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.
Severe Upper Limb Tremor Refractory to Medical Therapy
Radiation: Radiosurgical thalamotomy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Deep Brain Stimulation and Frameless Stereotactic Radiosurgery in the Treatment of Drug Resistant Invalidating Tremor|
- Tremor control (improvement in FTMTRS and/or UPDRS motor) [ Time Frame: 2 years ] [ Designated as safety issue: No ]Tremor control (improvement in Fahn Tolosa Marin Tremor Rating Scale, FTMTRS, and/or Unified Parkinson's Disease Rating Scale, UPDRS, motor)
- Targeting methodology validation (the lesions position, if present, will be compared to the treatment plan target position, deviations will be registered). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- The treatment safety will be evaluated. Toxicity will be registered according to NCI-CTCAE v3. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
|Experimental: Radiosurgical thalamotomy||Radiation: Radiosurgical thalamotomy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02095600
|Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy|
|Milan, Italy, 20133|