We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gamma Knife Radiosurgery for Treatment of Essential 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255929
Recruitment Status : Unknown
Verified June 2020 by Swedish Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : October 3, 2014
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Swedish Medical Center

Brief Summary:
The purpose of this study is to examine effects (good and bad) of gamma knife radiosurgery for essential tremor. The gamma knife places a small lesion in the brain to suppress tremors.

Condition or disease Intervention/treatment Phase
Essential Tremor Radiation: Gamma Knife Radiosurgery Not Applicable

Detailed Description:
This research is being done because although multiple studies evaluating gamma knife for essential tremor show good results, few studies evaluating patients prospectively have been done. Prior studies have looked at patient outcomes following treatment - also known as retrospective studies. In this study, data collection will initiate before treatment, to obtain consistent baseline evaluations from all study participants undergoing the gamma knife treatment and at specific intervals following treatment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 183 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gamma Knife Thalamotomy for Treatment of Essential Tremor
Actual Study Start Date : September 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gamma Knife Radiosurgery
Gamma Knife treatment is conducted in one day and takes approximately 70 to 90 minutes.
Radiation: Gamma Knife Radiosurgery



Primary Outcome Measures :
  1. Change in Effectiveness based on Clinical Rating Scale for Tumor (CRST-Part B) questionnaires. [ Time Frame: Baseline, 6, 12, 24, and 36 Months Post Treatment ]
  2. Change in Effectiveness based on QUEST (Quality of Life in Essential Tremor) questionnaires. [ Time Frame: Baseline, 6, 12, 24, and 36 Months Post Treatment ]

Secondary Outcome Measures :
  1. Safety Based on the Number of Incidences and Severity of Adverse Events Related with Gamma Knife Thalamotomy [ Time Frame: Baseline, 6, 12, 24, and 36 Months Post Treatment ]

Other Outcome Measures:
  1. Quality of Life based on the QUEST (Quality of Life in Essential Tremor) questionnaires [ Time Frame: Baseline, 6, 12, 24, and 36 Months Post Treatment ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women age 18 years or older
  • Diagnosis of essential tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon
  • Tremor following prior first line therapy with either propranolol or primidone
  • Must be able to undergo MRI of brain and CT of head for treatment planning
  • Postural or intention tremor severity score of greater than or equal to 2 in one hand/arm as measured by the CRST rating scale

Exclusion Criteria:

  • Prior ipsilateral stereotactic radiosurgical ablation of the thalamus, ipsilateral deep brain stimulation, radiofrequency ablation of a ipsilateral thalamic target, or ultrasound ablation of an ipsilateral thalamic target
  • Prior whole brain radiation therapy
  • Pregnancy

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 ClinicalTrials.gov identifier (NCT number): NCT02255929


Locations
Layout table for location information
United States, Washington
Swedish Medical Center Radiosurgery Center
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Swedish Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Christopher Loiselle, MD Swedish Medical Center Radiosurgery Center
Additional Information:
Layout table for additonal information
Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT02255929    
Other Study ID Numbers: IR 5585
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Swedish Medical Center:
Benign Essential Tremor
Tremor
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases
Additional relevant MeSH terms:
Layout table for MeSH terms
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases