Pre-lemniscal Radiation Deep Brain Stimulation for ET

Study Overview
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Brief Summary
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The hypothesis is that prelemniscal radiation (RaPRL) deep brain stimulation (DBS) is more effective for axial (head/neck/voice) tremor, and perhaps, appendicular tremor control in essential tremor patients.

Official Title
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Pre-lemniscal Radiation Deep Brain Stimulation for ET

Conditions
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Essential Tremor

Intervention / Treatment
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* Radiation: Pre-lemniscal Radiation Deep Brain Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of essential tremor based on clinical criteria established by the Essential Tremor Consortium Moderate or severe axial-dominant (head/neck/voice) tremor (Tremor Rating Scale [TRS] face, tongue, voice, head or trunk tremor score of 2 or above) May have bilateral appendicular tremor Tremor refractory to at least two medications, including primidone and propranolol Age between 21 and 75 Male or Female Significant disability due to essential tremor despite medical treatment (TRS score of 2 or above in any one of the items 16-23 [speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities]) Exclusion Criteria: Tremor due to other etiologies Pregnancy Presence of any other neurodegenerative disease Presence of significant cognitive impairment Presence of any medical condition that precludes neurological surgery Patients with another implanted stimulator or metallic implant, e.g. cochlear implant, cardiac pacemaker, spinal cord stimulator, aneurysm clips Patients who have a known need for future MRIs using a full body radio-frequency (RF) coil or a head transmit coil that extends over the chest area or that do not comply with Medtronic's MRI Guidelines for Medtronic Deep Brain Simulation Systems Patients with a history of seizures Patients with psychiatric illness that are not well controlled Patients with risk factors for intraoperative or postoperative bleeding (platelet count less than 125,000 per cubic millimeter, PT and PTT not within normal limits) Patients with brain tumors

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>preleminiscal radiation deep brain stimulation | Radiation: Pre-lemniscal Radiation Deep Brain Stimulation<br> <br> |
| Active Comparator: 2<br>VIM deep brain stimulation | Radiation: Pre-lemniscal Radiation Deep Brain Stimulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tremor rating scale axial score and total score |  | 3 months, 12 months and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life (SF 36 and clinical global impression of change) |  | 3 months, 12 months and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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essential tremor, deep brain stimulation