Radiosurgery for Drug Resistant Invalidating Tremor (DB-SRS)

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

Status

Completed

Conditions

Severe Upper Limb Tremor Refractory to Medical Therapy

Treatments

Radiation: Radiosurgical thalamotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02095600

DB-SRS

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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