Radiosurgery for Drug Resistant Invalidating Tremor

Severe Upper Limb Tremor Refractory to Medical Therapy Clinical Trial

— DB-SRS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095600
• Other study ID #: DB-SRS
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: July 2017

Study information

• Verified date: March 2019
• Source: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Severe Upper Limb Tremor Refractory to Medical Therapy
• Tremor

Intervention

Radiation:
• Radiosurgical thalamotomy

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Targeting methodology validation (the lesions position, if present, will be compared to the treatment plan target position, deviations will be registered).		2 years
Secondary	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