Trial record 14 of 38 for:    Open Studies | "Tremor"

Radiosurgery for Drug Resistant Invalidating Tremor (DB-SRS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor:
Information provided by (Responsible Party):
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
ClinicalTrials.gov Identifier:
NCT02095600
First received: March 21, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02095600

Locations
Italy
Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy Recruiting
Milan, Italy, 20133
Contact: Laura Fariselli, MD    +39022394 ext 2157    laura.fariselli@istituto-besta.it   
Contact: Marcello Marchetti, MD    +39022394 ext 2157    marchetti.m@istituto-besta.it   
Principal Investigator: Laura Fariselli, MD         
Sponsors and Collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
  More Information

No publications provided

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

Additional relevant MeSH terms:
Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014