Bilateral thalamic stimulation for essential tremor treatment

Directional Bilateral Thalamic Patterned Stimulation in Individuals with Essential Tremor

This study is testing a new brain stimulation treatment for people with essential tremor to see if it can safely improve their symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University of Toronto (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06325852 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of bilateral Ventral Intermedius Deep Brain Stimulation (VIM-DBS) in patients with essential tremor. It consists of two phases: the first phase is a cross-sectional investigation to identify the optimal stimulation algorithm, while the second phase is a prospective clinical trial assessing the outcomes of the stimulation. Patients who have previously undergone VIM-DBS but experienced loss of benefits, as well as those requiring DBS surgery, will be recruited for this study. Participants will receive bilateral implantation of advanced stimulation devices and undergo thorough monitoring.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 85 with essential tremor who have either not benefited from previous VIM-DBS or are in need of DBS surgery.

Not a fit: Patients who do not have essential tremor or those who have significant comorbidities that may interfere with the procedure may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve tremor control and quality of life for patients with essential tremor.

How similar studies have performed: Previous studies on deep brain stimulation for essential tremor have shown promising results, indicating that this approach is well-supported by existing research.

Eligibility criteria

Inclusion Criteria:

1. 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).
2. Phase 2: 10 Essential Tremor patients in need of DBS surgery.
3. Written and signed Informed Consent.
4. Age 18 to 85 years old.
5. 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) \[1\].
6. Soft signs (categorizing patients as Essential Tremor-plus) will be allowed and noted in the patient's chart.
7. Subject must be on stable dose of anti-tremor medication for at least 4 weeks prior to screening.
8. Subject had no botulinum injection for at least three months prior to screening.
9. Subject does not have a significant other medical condition biasing the study finding in investigator's opinion.

Exclusion Criteria:

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

Where this trial is running

Toronto, Ontario

• Movement Disorders Centre - Toronto Western Hospital — Toronto, Ontario, Canada (Recruiting)

Conditions Essential Tremor; Deep Brain Stimulation; Chronos Physician Programmer