Radiosurgery for Drug Resistant Invalidating Tremor (DB-SRS)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Identifier:
First received: March 21, 2014
Last updated: October 15, 2015
Last verified: October 2015

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.

Condition Intervention
Severe Upper Limb Tremor Refractory to Medical Therapy
Radiation: Radiosurgical thalamotomy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation and Frameless Stereotactic Radiosurgery in the Treatment of Drug Resistant Invalidating Tremor

Resource links provided by NLM:

Further study details as provided by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta:

Primary Outcome Measures:
  • Tremor control (improvement in FTMTRS and/or UPDRS motor) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Tremor control (improvement in Fahn Tolosa Marin Tremor Rating Scale, FTMTRS, and/or Unified Parkinson's Disease Rating Scale, UPDRS, motor)

Secondary Outcome Measures:
  • Targeting methodology validation (the lesions position, if present, will be compared to the treatment plan target position, deviations will be registered). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The treatment safety will be evaluated. Toxicity will be registered according to NCI-CTCAE v3. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.

Estimated Enrollment: 6
Study Start Date: April 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiosurgical thalamotomy Radiation: Radiosurgical thalamotomy


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT02095600

Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy
Milan, Italy, 20133
Sponsors and Collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
  More Information

Responsible Party: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Identifier: NCT02095600     History of Changes
Other Study ID Numbers: DB-SRS 
Study First Received: March 21, 2014
Last Updated: October 15, 2015
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on May 26, 2016