Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06325852

Directional Bilateral Thalamic Patterned Stimulation (Chronos)

Led by Alfonso Fasano · Updated on 2024-11-04

15

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

Sponsors

A

Alfonso Fasano

Lead Sponsor

B

Boston Scientific Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Directional Bilateral Thalamic Patterned Stimulation (Chronos)

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Phase 1: 5 to 10 tremor patients treated with VIM-DBS but experiencing early or late loss of benefits
  • Phase 2: 10 Essential Tremor patients needing DBS surgery
  • Signed informed consent
  • Age between 18 and 85 years old
  • Essential Tremor diagnosis with bilateral action tremor lasting at least three years
  • Patients with soft signs (Essential Tremor-plus) allowed and recorded
  • Stable anti-tremor medication dose for at least 4 weeks before screening
  • No botulinum injection within 3 months before screening
  • No significant other medical condition that could affect study results as judged by investigator
Not Eligible

You will not qualify if you...

  • Unable or unwilling to follow study procedures
  • Significant psychiatric or cognitive conditions affecting compliance
  • Untreated clinically significant depression
  • Current drug or alcohol abuse
  • History of suicide attempt within last year or active suicidal thoughts
  • Any medical condition interfering with study or evaluation
  • Terminal illness with life expectancy under 12 months
  • Participation in other interventional clinical trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Movement Disorders Centre - Toronto Western Hospital

Toronto, Ontario, Canada, M5T 2S8

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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