Recruiting

Chronos

Sponsor:

Alfonso Fasano

Code:

NCT06325852

Conditions

Essential Tremor

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

DBS programing

Study Details

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 ID

NCT06325852

Start date

Jul 16, 2024

Status verified date

Jul, 2024

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

15 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

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.

Primary outcome measure

  • Tremor Rating Scale (Part A-B) [ Time Frame: Phase 1-Baseline ]
  • Tremor analysis [ Time Frame: Phase 1-Baseline ]
  • Tremor Rating Scale (A-C) [ Time Frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 ]
  • Tremor analysis (meter per second squared) [ Time Frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 ]
  • Gait speed (meter per second) [ Time Frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 ]
  • Base of support (meter) [ Time Frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 ]
  • Step length (meter) [ Time Frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 ]
  • Stride length (meter) [ Time Frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 ]
  • Single stance time and double stance time (seconds) [ Time Frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 ]
  • Tandem gait [ Time Frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 ]
  • Posturography (newtons) [ Time Frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 ]
  • Quality of life in Essential Tremor Questionnaire (QUEST) [ Time Frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 ]
  • Speech analysis [ Time Frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8 ]

Central Contacts and Locations

Locations

Movement Disorders Centre - Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

More Information

Sponsor

Alfonso Fasano

Last update posted

Nov 4, 2024

Last verified

Jul, 2024

Keywords

  • Deep Brain Stimulation
  • Chronos Physician Programmer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Alfonso Fasano on 2024-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.