Directional Bilateral Thalamic Patterned Stimulation (Chronos)

NCT ID: NCT06325852

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-16
• Study Completion Date: 2027-01-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1

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.

Group Type: EXPERIMENTAL

DBS programing

Intervention Type: 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 2

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.

Group Type: EXPERIMENTAL

DBS programing

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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).

2. Phase 2: 10 Essential Tremor patients in need of DBS surgery.

3. Written and signed Informed Consent.

4. Age 18 to 85 years old.

5. 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].

6. Soft signs (categorizing patients as Essential Tremor-plus) will be allowed and noted in the patient's chart.

7. Subject must be on stable dose of anti-tremor medication for at least 4 weeks prior to screening.

8. Subject had no botulinum injection for at least three months prior to screening.

9. Subject does not have a significant other medical condition biasing the study finding in investigator's opinion.

Exclusion Criteria

1. Unwilling or inability to follow the procedures specified by the protocol.

2. Presence of significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study protocol.

3. Untreated clinically significant depression.

4. Any current drug or alcohol abuse, as determined by the investigator.

5. History of suicidal attempt within the last 1 year prior to consent or current active suicidal ideation as determined by the investigator.

6. Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.

7. Any terminal illness with life expectancy of < 12 months.

8. Participation in any other interventional clinical trial (e.g. drug, device).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Alfonso Fasano

OTHER

Sponsor Role: lead

Responsible Party

Alfonso Fasano

MD, PhD, FAAN, Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Movement Disorders Centre - Toronto Western Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Alfonso Fasano, MD, PhD

Role: primary

alfonso.fasano@uhn.ca

(416) 603-5800 ext. 5961

Other Identifiers

22-5772

Identifier Type: -

Identifier Source: org_study_id