Radiosurgery for Drug Resistant Invalidating Tremor

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Deep Brain Stimulation and Frameless Stereotactic Radiosurgery in the Treatment of Drug Resistant Invalidating Tremor

Conditions
-----------------
Severe Upper Limb Tremor Refractory to Medical Therapy

Intervention / Treatment
-----------------
* Radiation: Radiosurgical thalamotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients affected by severe upper limb tremor refractory to medical therapy and who are candidate for a deep brain stimulation (DBS) procedure. Age: ≥ 18 years old Refusal of DBS procedure Written consent Exclusion Criteria: Pregnancy Allergy to contrast medium DBS procedure susceptibility, if not refused

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiosurgical thalamotomy<br> | Radiation: Radiosurgical thalamotomy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tremor control (improvement in FTMTRS and/or UPDRS motor) | Tremor control (improvement in Fahn Tolosa Marin Tremor Rating Scale, FTMTRS, and/or Unified Parkinson's Disease Rating Scale, UPDRS, motor) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Targeting methodology validation (the lesions position, if present, will be compared to the treatment plan target position, deviations will be registered). |  | 2 years | 
| The treatment safety will be evaluated. Toxicity will be registered according to NCI-CTCAE v3. | 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. | 2 years |