Gamma Knife Radiosurgery for Treatment of Essential Tremor

Essential Tremor Clinical Trial

Official title:

Gamma Knife Thalamotomy for Treatment of Essential Tremor

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02255929
• Other study ID #: IR 5585
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: Swedish Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 183
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Radiation:
• Gamma Knife Radiosurgery

Locations

Country	Name	City	State
United States	Swedish Medical Center Radiosurgery Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 6, 12, 24, and 36 Months Post Treatment
Secondary	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	Baseline, 6, 12, 24, and 36 Months Post Treatment

External Links

•   Click here for more information about the Swedish Medical Center Radiosurgery Center