Gamma Knife Radiosurgery for Treatment of Essential Tremor

Not Applicable

Active, not recruiting

• Conditions: Essential Tremor
• Interventions: Radiation: Gamma Knife Radiosurgery

• Registration Number: NCT02255929
• Lead Sponsor: Swedish Medical Center

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.

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-30
• Study First Posted: 2014-10-03
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-23
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 183

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Effectiveness based on Clinical Rating Scale for Tumor (CRST-Part B) questionnaires.	Baseline, 6, 12, 24, and 36 Months Post Treatment	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.

Secondary Outcome Measures

Name	Time	Method
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	Adverse Events to be reported as mild, moderate or severe

Trial Locations

Locations (1)

Swedish Medical Center Radiosurgery Center; 🇺🇸 Seattle, Washington, United States