Radiosurgery for Drug Resistant Invalidating Tremor (DB-SRS)
Primary Purpose
Severe Upper Limb Tremor Refractory to Medical Therapy
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Radiosurgical thalamotomy
Sponsored by
About this trial
This is an interventional treatment trial for Severe Upper Limb Tremor Refractory to Medical Therapy
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
Sites / Locations
- Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiosurgical thalamotomy
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Targeting methodology validation (the lesions position, if present, will be compared to the treatment plan target position, deviations will be registered).
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.
Full Information
NCT ID
NCT02095600
First Posted
March 21, 2014
Last Updated
March 18, 2019
Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
1. Study Identification
Unique Protocol Identification Number
NCT02095600
Brief Title
Radiosurgery for Drug Resistant Invalidating Tremor
Acronym
DB-SRS
Official Title
Deep Brain Stimulation and Frameless Stereotactic Radiosurgery in the Treatment of Drug Resistant Invalidating Tremor
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Upper Limb Tremor Refractory to Medical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiosurgical thalamotomy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Radiosurgical thalamotomy
Primary Outcome Measure Information:
Title
Tremor control (improvement in FTMTRS and/or UPDRS motor)
Description
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
Secondary Outcome Measure Information:
Title
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
Title
The treatment safety will be evaluated. Toxicity will be registered according to NCI-CTCAE v3.
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy
City
Milan
ZIP/Postal Code
20133
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Radiosurgery for Drug Resistant Invalidating Tremor
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