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OpenTrials
Completed

NCT Number: NCT02095600

Radiosurgery for Drug Resistant Invalidating Tremor

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy

Milan, 20133, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiosurgical thalamotomy

Radiation

Primary outcomes

  1. Tremor control (improvement in FTMTRS and/or UPDRS motor)

    Time frame: 2 years

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

Secondary outcomes

  1. 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

  2. The treatment safety will be evaluated. Toxicity will be registered according to NCI-CTCAE v3.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: DB-SRS

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Mar 26, 2014
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.