Directional Bilateral Thalamic Patterned Stimulation (Chronos)

Ki vehet részt

• Phase 1: 5 to 10 tremor patients already treated with VIM-DBS but not doing well due to early and/or late loss of benefits (i.e. tremor scores ON stimulation identical or greater than before surgery in absence of stimulation)
• Phase 2: 10 Essential Tremor patients in need of DBS surgery
• Written and signed Informed Consent
• Age 18 to 85 years old
• Subject must have Essential Tremor, as defined by all the following criteria: (a) isolated tremor syndrome consisting of bilateral action tremor; (b) at least three years duration; and (c) with or without tremor in other locations (e.g., head, voice, or low limbs) [1]
• Soft signs (categorizing patients as Essential Tremor-plus) will be allowed and noted in the patient's chart
• Subject must be on stable dose of anti-tremor medication for at least 4 weeks prior to screening
• Subject had no botulinum injection for at least three months prior to screening
• Subject does not have a significant other medical condition biasing the study finding in investigator's opinion

Ki nem vehet részt

• Any current drug or alcohol abuse, as determined by the investigator
• History of suicidal attempt within the last 1 year prior to consent or current active suicidal ideation as determined by the investigator
• Participation in any other interventional clinical trial (e.g. drug, device)
• Presence of significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study protocol
• Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints
• Any terminal illness with life expectancy of < 12 months
• Unwilling or inability to follow the procedures specified by the protocol
• Untreated clinically significant depression