Overview

This trial is active, not recruiting.

Condition severe upper limb tremor refractory to medical therapy
Treatment radiosurgical thalamotomy
Sponsor Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Start date April 2011
End date January 2017
Trial size 6 participants
Trial identifier NCT02095600, DB-SRS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
radiosurgical thalamotomy

Primary Outcomes

Measure
Tremor control (improvement in FTMTRS and/or UPDRS motor)
time frame: 2 years

Secondary Outcomes

Measure
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
The treatment safety will be evaluated. Toxicity will be registered according to NCI-CTCAE v3.
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Deep Brain Stimulation and Frameless Stereotactic Radiosurgery in the Treatment of Drug Resistant Invalidating Tremor
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta.