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Directional Bilateral Thalamic Patterned Stimulation (Chronos)

NCT06325852 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-11-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Alfonso Fasano

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-16
Primary Completion
2026-04-01
Completion
2027-01-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06325852 on ClinicalTrials.gov