Bilateral thalamic stimulation for essential tremor treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Encora X1 in Daily Life for Essential Tremor

  This real-world study tests how the Encora X1 wrist device affects day-to-day activities for adults with essential tremor over three years.

  Recruiting Encora, Inc. · Boston, Massachusetts · NCT07911488

• Intraoperative Microelectrode Recordings with MAVEN vs Standard Equipment

  This study tests whether MAVEN can match the recording data collected during DBS surgery for movement disorders using standard equipment.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07868614

• Microelectrode-based brain stimulation for Parkinson’s and essential tremor

  This early feasibility test checks a new microelectrode-based brain stimulation method in adults with Parkinson’s disease or essential tremor who are already getting deep brain stimulation implants.

  Recruiting Lund University · Lund, Skåne County · NCT07820189

• Non-Invasive Nerve Stimulation for Essential Tremor: Long-Term Safety and Effectiveness

  This study tests whether a non-invasive stimulation device called TAPS helps reduce tremor in adults with essential tremor over a long period.

  Recruiting Ruijin Hospital · Shanghai · NCT07774598

• Low Intensity Focused Ultrasound for Essential Tremor in Adults

  This early-stage, open-label study tests whether repeated low-intensity focused ultrasound can safely and briefly modulate tremor in people with essential tremor.

  Recruiting Early Phase 1 University of California, Los Angeles · Los Angeles, California · NCT07599592

• Closed-loop TMS to reduce tremor

  This trial tries phase-locked transcranial magnetic stimulation (TMS) to reduce tremor in people with essential tremor or Parkinson's disease.

  Recruiting University of Oxford · Oxford, Oxfordshire · NCT07574164

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.