Gamma Knife Radiosurgery for Treatment of Essential Tremor

NCT ID: NCT02255929

Last Updated: 2023-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2023-12-31

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.

Conditions

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Essential Tremor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gamma Knife Radiosurgery

Gamma Knife treatment is conducted in one day and takes approximately 70 to 90 minutes.

Group Type EXPERIMENTAL

Gamma Knife Radiosurgery

Intervention Type RADIATION

Interventions

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Gamma Knife Radiosurgery

Intervention Type RADIATION

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Loiselle, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Medical Center Radiosurgery Center

Locations

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Swedish Medical Center Radiosurgery Center

Seattle, Washington, United States

Site Status

Countries

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United States

Related Links

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http://www.swedish.org/services/radiosurgery-center

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

Other Identifiers

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IR 5585

Identifier Type: -

Identifier Source: org_study_id

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