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Gamma Knife Radiosurgery for Treatment of Essential Tremor

S

Swedish Medical Center

Status

Active, not recruiting

Conditions

Essential Tremor

Treatments

Radiation: Gamma Knife Radiosurgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02255929
IR 5585

Details and patient eligibility

About

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.

Full 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.

Enrollment

183 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

183 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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