Directional Bilateral Thalamic Patterned Stimulation (Chronos)

Essential Tremor Clinical Trial

Official title:

Directional Bilateral Thalamic Patterned Stimulation in Individuals With Essential Tremor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06325852
• Other study ID #: 22-5772
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: May 2024
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: January 1, 2027
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

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.

Locations

Country	Name	City	State
Canada	Movement Disorders Centre - Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Alfonso Fasano	Boston Scientific Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tremor Rating Scale (Part A-B)	Range from 0-46. with 0 representing no tremor and 46 representing severe tremor.	Phase 1-Baseline
Primary	Tremor analysis	Using accelerometers	Phase 1-Baseline
Primary	Tremor Rating Scale (A-C)	Range from 0-46. with 0 representing no tremor and 46 representing severe tremor.	Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Primary	Tremor analysis (meter per second squared)	Using accelerometers	Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Primary	Gait speed (meter per second)	Gait Analysis	Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Primary	Base of support (meter)	Gait Analysis	Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Primary	Step length (meter)	Gait Analysis	Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Primary	Stride length (meter)	Gait Analysis	Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Primary	Single stance time and double stance time (seconds)	Gait Analysis	Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Primary	Tandem gait	Gait Analysis	Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Primary	Posturography (newtons)	Using Proteokinetics Zeno System	Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Primary	Quality of life in Essential Tremor Questionnaire (QUEST)	Range from 0-40, with 0 representing no tremor and 40 representing severe tremor.	Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Primary	Speech analysis	automated analysis pipeline in MatLab	Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8