Radiosurgery for Drug Resistant Invalidating Tremor
DB-SRS
Deep Brain Stimulation and Frameless Stereotactic Radiosurgery in the Treatment of Drug Resistant Invalidating Tremor
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 21, 2014
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedMarch 20, 2019
March 1, 2019
5.7 years
March 21, 2014
March 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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.
2 years
Study Arms (1)
Radiosurgical thalamotomy
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Allergy to contrast medium
- DBS procedure susceptibility, if not refused
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy
Milan, 20133, Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2014
First Posted
March 26, 2014
Study Start
April 1, 2011
Primary Completion
December 1, 2016
Study Completion
July 1, 2017
Last Updated
March 20, 2019
Record last verified: 2019-03