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NCT Number: NCT06325852

Directional Bilateral Thalamic Patterned Stimulation (Chronos)

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.

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Movement Disorders Centre - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location status: Recruiting

Location contact

Alfonso Fasano, MD, PhD

CONTACT

[email protected]

(416) 603-5800 ext. 5961

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

DBS programing

Other

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 outcomes

  1. Tremor Rating Scale (Part A-B)

    Time frame: Phase 1-Baseline

    Range from 0-46. with 0 representing no tremor and 46 representing severe tremor.

  2. Tremor analysis

    Time frame: Phase 1-Baseline

    Using accelerometers

  3. Tremor Rating Scale (A-C)

    Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

    Range from 0-46. with 0 representing no tremor and 46 representing severe tremor.

  4. Tremor analysis (meter per second squared)

    Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

    Using accelerometers

  5. Gait speed (meter per second)

    Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

    Gait Analysis

  6. Base of support (meter)

    Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

    Gait Analysis

  7. Step length (meter)

    Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

    Gait Analysis

  8. Stride length (meter)

    Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

    Gait Analysis

  9. Single stance time and double stance time (seconds)

    Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

    Gait Analysis

  10. Tandem gait

    Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

    Gait Analysis

  11. Posturography (newtons)

    Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

    Using Proteokinetics Zeno System

  12. Quality of life in Essential Tremor Questionnaire (QUEST)

    Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

    Range from 0-40, with 0 representing no tremor and 40 representing severe tremor.

  13. Speech analysis

    Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

    automated analysis pipeline in MatLab

Sponsors and collaborators

Lead sponsor

Alfonso Fasano

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

Directional Bilateral Thalamic Patterned Stimulation in Individuals with Essential Tremor

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 22, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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