Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01734122
Recruitment Status : Recruiting
First Posted : November 27, 2012
Last Update Posted : March 27, 2018
Information provided by (Responsible Party):
Austin Kirschner, Vanderbilt University Medical Center

Brief Summary:
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). This is a questionnaire-based study. Please see Detailed Description below for more information.

Condition or disease
Tremor Essential Tremor Parkinson Disease Radiosurgery Quality of Life

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
Study Start Date : November 2012
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor
U.S. FDA Resources

Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 1 year ]
    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 :
  1. Severity of Tremor [ Time Frame: 1 year ]
    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.

  2. Neuropsychological Assessment [ Time Frame: Baseline and 6 months post-treatment ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01734122

United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Send Patient Referrals to 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         
Sub-Investigator: Hong Yu, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center

Additional Information:
Responsible Party: Austin Kirschner, Assistant Professor, Vanderbilt University Medical Center Identifier: NCT01734122     History of Changes
Other Study ID Numbers: 120632
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

Keywords provided by Austin Kirschner, Vanderbilt University Medical Center:
Stereotactic Radiosurgery
Essential Tremor
Parkinsonian Tremor
Quality of Life
Severity of Tremor

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