Gamma Knife Radiosurgery for Treatment of Essential Tremor

Swedish Medical Center183 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

183

Conditions

Essential Tremor

Interventions

Gamma Knife RadiosurgeryRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Swedish Medical Center Radiosurgery Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 6, 12, 24, and 36 Months Post Treatment

Secondary Outcomes

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

Time frame: Baseline, 6, 12, 24, and 36 Months Post Treatment

Data from ClinicalTrials.gov

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