RecruitingNCT06325852Updated Nov 4, 2024

Directional Bilateral Thalamic Patterned Stimulation (Chronos)

An interventional study of DBS programing in Essential Tremor, sponsored by Alfonso Fasano. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-04.

Sponsored by Alfonso Fasano · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 15
Allocation: Non-randomized
Ages: 18 Years to 85 Years
Sex: All

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 studied

Essential Tremor

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Keywords

Deep Brain Stimulation
Chronos Physician Programmer

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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).

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 15 participants (estimated)

Study 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.
Other: DBS programing
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.
Other: DBS programing

Interventions

OtherDBS 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.

What researchers measure

Primary outcomes

Tremor Rating Scale (Part A-B)
Range from 0-46. with 0 representing no tremor and 46 representing severe tremor.
Time frame: Phase 1-Baseline
Tremor analysis
Using accelerometers
Time frame: Phase 1-Baseline
Tremor Rating Scale (A-C)
Range from 0-46. with 0 representing no tremor and 46 representing severe tremor.
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Tremor analysis (meter per second squared)
Using accelerometers
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Gait speed (meter per second)
Gait Analysis
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Base of support (meter)
Gait Analysis
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Step length (meter)
Gait Analysis
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Stride length (meter)
Gait Analysis
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Single stance time and double stance time (seconds)
Gait Analysis
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Tandem gait
Gait Analysis
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Posturography (newtons)
Using Proteokinetics Zeno System
Time frame: 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.
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Speech analysis
automated analysis pipeline in MatLab
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8

Study locations

1 of 1 sites recruiting

Movement Disorders Centre - Toronto Western Hospital
Toronto, Ontario M5T 2S8, Canada
- Alfonso Fasano, MD, PhD · Contact · alfonso.fasano@uhn.ca · (416) 603-5800
Recruiting

Registry details

Key details

Study ID: NCT06325852
Lead sponsor: Alfonso Fasano
Collaborators: Boston Scientific Corporation
Responsible party: Alfonso Fasano (MD, PhD, FAAN, Professor, University of Toronto) — Sponsor-investigator
First posted: Mar 22, 2024
Start date: Jul 16, 2024
Primary completion: Apr 1, 2026 (estimated)
Completion: Jan 1, 2027 (estimated)
Last update: Nov 4, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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