Radiosurgery for Drug Resistant Invalidating Tremor

Not Applicable

Completed

• Conditions: Severe Upper Limb Tremor Refractory to Medical Therapy

• Registration Number: NCT02095600
• Lead Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Primary Completion: 2016-12
• Study Completion: 2017-07
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tremor control (improvement in FTMTRS and/or UPDRS motor)	2 years	Tremor control (improvement in Fahn Tolosa Marin Tremor Rating Scale, FTMTRS, and/or Unified Parkinson's Disease Rating Scale, UPDRS, motor)

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy; 🇮🇹 Milan, Italy