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Recruiting NCT06325852

Directional Bilateral Thalamic Patterned Stimulation (Chronos)

No phase Interventional Essential Tremor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DBS programing.
Who it may be relevant to
Registry conditions: Essential Tremor. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Directional Bilateral Thalamic Patterned Stimulation in Individuals with Essential Tremor

Overview

Population Size and Eligible Patients: The investigators aim to recruit 5 to 10 patients with tremors who have previously undergone Ventral Intermedius Deep Brain Stimulation (VIM-DBS) treatment but have experienced early or late loss of benefits. Additionally, the investigators will enroll ten patients with essential tremor who require VIM-DBS surgery. These individuals will undergo bilateral implantation of Boston Scientific Genus Implantable Pulse Generator (IPG) devices, connected to Boston Scientific Cartesia™ 8-contact Directional Leads. Study Design: This study comprises two distinct phases. Phase 1 is a cross-sectional investigation designed to identify the optimal algorithm for patterned stimulation in the VIM region . Phase 2 is a prospective clinical trial focusing on the assessment of safety and efficacy of bilateral VIM-DBS in patients with essential tremor. Objectives: The primary objective in Phase 2 is to evaluate the safety and effectiveness of bilateral VIM-DBS in individuals with essential tremor. In Phase 1, the investigators seek to explore the impact of the Chronos programming software on tremor patients who have experienced early or late loss of benefits.

Interventions

  • Other DBS programing
    The physician will utilize the Boston Scientific Chronos Clinician Programmer (software) to make adjustments to the Deep Brain Stimulation (DBS) settings for the patients.

Primary outcome measures

  • Tremor Rating Scale (Part A-B) [Time frame: Phase 1-Baseline]
  • Tremor analysis [Time frame: Phase 1-Baseline]
  • Tremor Rating Scale (A-C) [Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8]
  • Tremor analysis (meter per second squared) [Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8]
  • Gait speed (meter per second) [Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8]
  • Base of support (meter) [Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8]
  • Step length (meter) [Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8]
  • Stride length (meter) [Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8]
  • Single stance time and double stance time (seconds) [Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8]
  • Tandem gait [Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Unwilling or inability to follow the procedures specified by the protocol.
  • Presence of significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study protocol.
  • Untreated clinically significant depression.
  • 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.
  • 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.
  • Participation in any other interventional clinical trial (e.g. drug, device).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Movement Disorders Centre - Toronto Western Hospital — Toronto

Identifiers

NCT: NCT06325852 · 22-5772

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗