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Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Austin Kirschner, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01734122
First received: November 20, 2012
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine the changes in quality of life and degree of tremor for patients with essential tremor or Parkinsonian tremor who are treated by stereotactic radiosurgery (SRS).


Condition
Tremor
Essential Tremor
Parkinson Disease
Radiosurgery
Quality of Life

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The tremor-related quality of life for each patient will be assessed by self-assessment questionnaire at 3 month intervals for 1 year after treatment by stereotactic radiation.


Secondary Outcome Measures:
  • Severity of Tremor [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The severity of tremor will be assessed by objective measure (Fahn-Tolosa-Marin tremor rating scale) at 3 month intervals for 1 year following the stereotactic radiation treatment.

  • Neuropsychological Assessment [ Time Frame: Baseline and 6 months post-treatment ] [ Designated as safety issue: No ]
    All patients will undergo a neuropsychological assessment (1-2 hr examination) at baseline and at 6 months post-treatment. This will assess any unanticipated changes in neuropsychological brain function.


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This trial enrolls persons with essential tremor or Parkinsonian tremor that is inadequately controlled by medications.

Criteria

Inclusion Criteria:

  • Must be certified by a neurologist as having essential tremor or Parkinsonian tremor that is insufficiently controlled by medication alone.
  • Preference to receive radiation treatment for tremor treatment, rather than surgical DBS implantation or surgical thalamotomy
  • At least 18 years old

Exclusion Criteria:

  • Contraindications to cranial radiation (such as prior radiation to the thalamus)
  • Inability to have a MRI of the brain
  • Prior surgical thalamotomy treatment (but contralateral deep brain stimulator [DBS] is permitted)
  • Estimated life expectancy less than 1 year
  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: NCT01734122

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Vanderbilt University Movement Disorder Coordinators    615-322-0141 ext Fax 6153436847      
Contact: Vanderbilt University Radiation Oncology (nursing staff)    615-343-2624      
Principal Investigator: Austin N. Kirschner, MD, PhD         
Principal Investigator: Anthony J. Cmelak, MD         
Sub-Investigator: Joseph S. Neimat, MD         
Sub-Investigator: Fenna T. Phibbs, MD, MPH         
Sub-Investigator: Peter Hedera, MD         
Sub-Investigator: Scott A Wylie, PhD         
Sponsors and Collaborators
Vanderbilt University
  More Information

Additional Information:
No publications provided

Responsible Party: Austin Kirschner, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01734122     History of Changes
Other Study ID Numbers: 120632
Study First Received: November 20, 2012
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Stereotactic Radiosurgery
Essential Tremor
Parkinsonian Tremor
Quality of Life
Severity of Tremor

Additional relevant MeSH terms:
Tremor
Essential Tremor
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014