Essential Tremor
Conditions
Keywords
Benign Essential Tremor, Tremor, Neurologic Manifestations, Nervous System Diseases, Movement Disorders, Central Nervous System Diseases
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.
Interventions
RADIATIONGamma Knife Radiosurgery
Sponsors
Swedish Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed