Radiosurgery for Drug Resistant Invalidating Tremor

NCT02095600 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-03-20

No results posted yet for this study

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.

Conditions

  • Severe Upper Limb Tremor Refractory to Medical Therapy

Interventions

RADIATION

Radiosurgical thalamotomy

Sponsors & Collaborators

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2016-12-31
Completion
2017-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02095600 on ClinicalTrials.gov