Gamma Knife Radiosurgery for Treatment of Essential Tremor

Sponsor

Swedish Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02255929

Collaborator

(none)

183

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Tremor	Radiation: Gamma Knife Radiosurgery	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

183 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Gamma Knife Thalamotomy for Treatment of Essential Tremor

Actual Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gamma Knife Radiosurgery Gamma Knife treatment is conducted in one day and takes approximately 70 to 90 minutes.	Radiation: Gamma Knife Radiosurgery

Arm

Intervention/Treatment

Experimental: Gamma Knife Radiosurgery

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

Radiation: Gamma Knife Radiosurgery

Outcome Measures

Primary Outcome Measures

Change in Effectiveness based on Clinical Rating Scale for Tumor (CRST-Part B) questionnaires. [Baseline, 6, 12, 24, and 36 Months Post Treatment]
Change in Effectiveness based on QUEST (Quality of Life in Essential Tremor) questionnaires. [Baseline, 6, 12, 24, and 36 Months Post Treatment]

Secondary Outcome Measures

Safety Based on the Number of Incidences and Severity of Adverse Events Related with Gamma Knife Thalamotomy [Baseline, 6, 12, 24, and 36 Months Post Treatment]

Other Outcome Measures

Quality of Life based on the QUEST (Quality of Life in Essential Tremor) questionnaires [Baseline, 6, 12, 24, and 36 Months Post Treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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