Essential TremorNCT06325852
Directional Bilateral Thalamic Patterned Stimulation (Chronos)
A study testing DBS programing in people with Essential Tremor, run by Alfonso Fasano at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- DBS programing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jul 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Movement Disorders Centre - Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Alfonso Fasano, MD, PhD, (416) 603-5800 ext. 5961, alfonso.fasano@uhn.ca
About this study
Official title: Directional Bilateral Thalamic Patterned Stimulation in Individuals with Essential Tremor
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
- Being tested
- DBS programing
- Keywords
- Deep Brain Stimulation, Chronos Physician Programmer
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS programingOther
The physician will utilize the Boston Scientific Chronos Clinician Programmer (software) to make adjustments to the Deep Brain Stimulation (DBS) settings for the patients.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | 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. Receives: Other: DBS programing |
| Phase 2 | Experimental | 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. Receives: Other: DBS programing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor Rating Scale (Part A-B)
Range from 0-46. with 0 representing no tremor and 46 representing severe tremor.
Measured: Phase 1-Baseline
Tremor analysis
Using accelerometers
Measured: Phase 1-Baseline
Tremor Rating Scale (A-C)
Range from 0-46. with 0 representing no tremor and 46 representing severe tremor.
Measured: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Tremor analysis (meter per second squared)
Using accelerometers
Measured: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Gait speed (meter per second)
Gait Analysis
Measured: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Base of support (meter)
Gait Analysis
Measured: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Step length (meter)
Gait Analysis
Measured: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Stride length (meter)
Gait Analysis
Measured: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Single stance time and double stance time (seconds)
Gait Analysis
Measured: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Tandem gait
Gait Analysis
Measured: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Posturography (newtons)
Using Proteokinetics Zeno System
Measured: 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.
Measured: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Speech analysis
automated analysis pipeline in MatLab
Measured: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start16 Jul 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alfonso Fasano
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, Alfonso Fasano, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325852
- Sponsor's protocol ID
- 22-5772
- Status last verified
- Jul 2024
- First submitted
- 13 Mar 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directional Bilateral Thalamic Patterned Stimulation in Individuals with Essential Tremor
- ClinicalTrials.gov ID
- NCT06325852
- Acronym / sponsor ID
- 22-5772
- Conditions
- Essential Tremor
- Keywords
- Deep Brain Stimulation, Chronos Physician Programmer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Alfonso FasanoUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Other: DBS programing5 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. |
| Phase 2 | Experimental | Other: DBS programingTen 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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].
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBS programingThe physician will utilize the Boston Scientific Chronos Clinician Programmer (software) to make adjustments to the Deep Brain Stimulation (DBS) settings for the patients. | Other | Phase 1, Phase 2 |
Primary outcome
Tremor Rating Scale (Part A-B)
Time frame: Phase 1-Baseline
Range from 0-46. with 0 representing no tremor and 46 representing severe tremor.
Tremor analysis
Time frame: Phase 1-Baseline
Using accelerometers
Tremor Rating Scale (A-C)
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Range from 0-46. with 0 representing no tremor and 46 representing severe tremor.
Tremor analysis (meter per second squared)
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Using accelerometers
Gait speed (meter per second)
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Gait Analysis
Base of support (meter)
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Gait Analysis
Step length (meter)
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Gait Analysis
Stride length (meter)
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Gait Analysis
Single stance time and double stance time (seconds)
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Gait Analysis
Tandem gait
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Gait Analysis
Posturography (newtons)
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Using Proteokinetics Zeno System
Quality of life in Essential Tremor Questionnaire (QUEST)
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
Range from 0-40, with 0 representing no tremor and 40 representing severe tremor.
Speech analysis
Time frame: Phase 2-Baseline, Month 2, Month 4, Month 6, Month 8
automated analysis pipeline in MatLab
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Movement Disorders Centre - Toronto Western Hospital
Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS programing in people with Essential Tremor, run by Alfonso Fasano at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremor Rating Scale (Part A-B) (time frame: Phase 1-Baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.