Directional Bilateral Thalamic Patterned Stimulation (Chronos)

NCT06325852 | Recruiting

• 1 other identifier: 22-5772
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Essential Tremor

Keywords

Deep Brain Stimulation; Chronos Physician Programmer

Outcome Measures

Primary Outcomes (13)

• Tremor Rating Scale (Part A-B)

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

  Phase 1-Baseline

• Tremor analysis

  Using accelerometers

  Phase 1-Baseline

• Tremor Rating Scale (A-C)

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

  Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

• Tremor analysis (meter per second squared)

  Using accelerometers

  Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

• Gait speed (meter per second)

  Gait Analysis

  Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

• Base of support (meter)

  Gait Analysis

  Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

• Step length (meter)

  Gait Analysis

  Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

• Stride length (meter)

  Gait Analysis

  Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

• Single stance time and double stance time (seconds)

  Gait Analysis

  Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

• Tandem gait

  Gait Analysis

  Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

• Posturography (newtons)

  Using Proteokinetics Zeno System

  Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

• Quality of life in Essential Tremor Questionnaire (QUEST)

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

  Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

• Speech analysis

  automated analysis pipeline in MatLab

  Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

Study Arms (2)

Phase 1

EXPERIMENTAL

5 to 10 patients with tremor already treated with VIM-DBS but not doing well because of early or late loss of benefits will be recruited by the PI over a 6 months period. If interested, the potential participants will be screened, informed, and consented by a research coordinator. Before the replacement of their IPG (implantable pulse generator), a baseline measurement will be performed.

Other: DBS programing

Phase 2

EXPERIMENTAL

Ten patients with ET needing DBS-VIM surgery will be recruited and will receive Boston Scientific Genus IPG bilaterally connected to Boston Scientific Cartesia™ 8-contact Directional Leads. The programming will be done in four different settings/periods during the course of 8 months.

Other: DBS programing

Interventions

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.

Phase 1; Phase 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alfonso Fasano: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Movement Disorders Centre - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, FAAN, Professor

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 22, 2024
• Study Start: July 16, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 4, 2024

Record last verified: 2024-07

Locations

CA (1)