Back to resultsGamma Knife Radiosurgery for Treatment of Essential Tremor
Primary Purpose
Essential Tremor
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gamma Knife Radiosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor focused on measuring Benign Essential Tremor, Tremor, Neurologic Manifestations, Nervous System Diseases, Movement Disorders, Central Nervous System Diseases
Eligibility 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
Sites / Locations
- Swedish Medical Center Radiosurgery Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gamma Knife Radiosurgery
Arm Description
Gamma Knife treatment is conducted in one day and takes approximately 70 to 90 minutes.
Outcomes
Primary Outcome Measures
Change in Effectiveness based on Clinical Rating Scale for Tumor (CRST-Part B) questionnaires.
The change observed is represented by a writing and drawing score assessment of tremors. The assessment is conducted by a movement disorder neurologist in a blinded fashion.
Secondary Outcome Measures
Safety Based on the Number of Incidences and Severity of Adverse Events Related with Gamma Knife Thalamotomy
Adverse Events to be reported as mild, moderate or severe
Full Information
NCT ID
NCT02255929
First Posted
September 17, 2014
Last Updated
January 19, 2023
Sponsor
Swedish Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02255929
Brief Title
Gamma Knife Radiosurgery for Treatment of Essential Tremor
Official Title
Gamma Knife Thalamotomy for Treatment of Essential Tremor
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2014 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
Benign Essential Tremor, Tremor, Neurologic Manifestations, Nervous System Diseases, Movement Disorders, Central Nervous System Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
183 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gamma Knife Radiosurgery
Arm Type
Experimental
Arm Description
Gamma Knife treatment is conducted in one day and takes approximately 70 to 90 minutes.
Intervention Type
Radiation
Intervention Name(s)
Gamma Knife Radiosurgery
Primary Outcome Measure Information:
Title
Change in Effectiveness based on Clinical Rating Scale for Tumor (CRST-Part B) questionnaires.
Description
The change observed is represented by a writing and drawing score assessment of tremors. The assessment is conducted by a movement disorder neurologist in a blinded fashion.
Time Frame
Baseline, 6, 12, 24, and 36 Months Post Treatment
Secondary Outcome Measure Information:
Title
Safety Based on the Number of Incidences and Severity of Adverse Events Related with Gamma Knife Thalamotomy
Description
Adverse Events to be reported as mild, moderate or severe
Time Frame
Baseline, 6, 12, 24, and 36 Months Post Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Loiselle, MD
Organizational Affiliation
Swedish Medical Center Radiosurgery Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Medical Center Radiosurgery Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.swedish.org/services/radiosurgery-center
Description
Click here for more information about the Swedish Medical Center Radiosurgery Center
Learn more about this trial
Gamma Knife Radiosurgery for Treatment of Essential Tremor
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