Gamma Knife Radiosurgery for Treatment of Essential Tremor

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gamma Knife Thalamotomy for Treatment of Essential Tremor

Conditions
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Essential Tremor

Intervention / Treatment
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* Radiation: Gamma Knife Radiosurgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gamma Knife Radiosurgery<br>Gamma Knife treatment is conducted in one day and takes approximately 70 to 90 minutes. | Radiation: Gamma Knife Radiosurgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Essential Tremor, Tremor, Neurologic Manifestations, Nervous System Diseases, Movement Disorders, Central Nervous System Diseases