Essential TremorNCT07302867
Neuromodulation Strategies for Treatment-Resistant Essential Tremor Using Chronos™ DBS
A study testing Continuous, Continuous + High Frequency Cycling and High Frequency in people with Essential Tremor, run by University of British Columbia at 1 site in Canada.
Trial summary
The goal of this observational study is to learn whether a new way of programming Deep Brain Stimulation (DBS) can improve and maintain tremor control in adults with essential tremor (ET) who stopped responding to standard DBS therapy. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Continuous, Continuous + High Frequency Cycling and High Frequency
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2026to 1 Apr 2028
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with essential tremor who have undergone standard Vim-DBS surgery
- Demonstrated rapid (early) habituation to standard programming.
- Ability to provide informed consent and attend follow-up visits.
Who cannot join
- Inability to attend programming visits.
- Cognitive or language impairment precluding consent.
- Other neurological conditions confounding tremor assessment.
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
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
Danielle A Pietramala, 604-875-4111 ext. 68396, danielle.pietram@ubc.ca
Christopher R Honey
About this study
Official title: Neuromodulation in Treatment Resistant Essential Tremor in Early Habituation - Investigating Low and High Frequencies / Waveform Shaping / Pulse and Bursts / Combination Therapy in Deep Brain Stimulation Utilizing the Boston Scientific® Chronos™ Software
The goal of this observational study is to learn whether a new way of programming Deep Brain Stimulation (DBS) can improve and maintain tremor control in adults with essential tremor (ET) who stopped responding to standard DBS therapy.
The main questions it aims to answer are:
Read more
- 1. Can advanced DBS settings, using varied stimulation patterns, frequencies, and pulses, restore tremor control in people with ET who lost benefit from standard Ventral Intermedius Deep Brain Stimulation (VIM-DBS)?
- 2. Do these advanced settings provide more stable, longer-lasting tremor improvement over time?
Researchers will compare six different stimulation settings to see if any of them can improve tremor symptoms when standard DBS programming no longer works.
Participants will:
- Complete a clinic visit where they try six different DBS stimulation settings using specialized Chronos software.
- Be randomly assigned to one of these settings to use at home.
- Receive a follow-up phone call at 4 weeks to check on symptoms and device use.
- Return to the clinic at 3 months for a full tremor evaluation.
- Have the option to return for an additional follow-up visit at 1 year.
This study will include 5 participants with essential tremor who previously lost benefit quickly after receiving standard VIM-DBS treatment.
Read the detailed description
- Purpose: To test whether new DBS programming patterns can restore and sustain tremor control in essential tremor (ET) patients who lose benefit quickly after standard Vim-DBS.
- Hypothesis: Novel stimulation paradigms - like high-frequency, microburst, cycling, and scheduling - can overcome early habituation and provide lasting tremor improvement.
- Justification: Some ET patients experience rapid loss of benefit despite correct DBS placement. Standard programming does not help them, creating a disabling condition. Advanced programming may offer a safe, non-surgical solution.
- Objectives:
- 1. Determine if Chronos™ software programs maintain tremor improvement beyond one month.
- 2. Assess safety, tolerability, and identify the most effective stimulation parameters.
- Research Design: Prospective, single-center cohort study of 5 early-habituating ET patients. Patients trial six stimulation paradigms in clinic, then are randomized to one program for home use. Follow-up occurs at 4 weeks, 3 months, and optionally 1 year.
- Statistical Analysis: Descriptive statistics due to small sample size. Outcomes include tremor ratings, patient-reported benefit, and recurrence of habituation.
- Conditions
- Essential Tremor
- Being tested
- Continuous, Continuous + High Frequency Cycling, High Frequency, Microburst, Scheduling
- Keywords
- Deep Brain Stimulation, Essential Tremor
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ContinuousOther
DBS setting: 185 Hz, 60 µs pulse width, optimized amplitude
Continuous + High Frequency CyclingOther
DBS setting: Alternates 30s at 185 Hz and 30s at 1000 Hz
High FrequencyOther
DBS setting: 1000 Hz continuous, 60 µs, optimized amplitude
MicroburstOther
DBS setting: 900 Hz intraburst, 80 Hz interburst, 6 pulses per packet
SchedulingOther
DBS setting: Two or three effective programs on alternating schedules
CyclingOther
DBS setting: 30s on / 5s off cycle without ramp, subthreshold stimulation
| Study group | Role | What they receive |
|---|---|---|
| Single Experimental Arm | Experimental | All participants will test six different experimental DBS stimulation programs in the clinic using Chronos™ software. After trying all six programs, each participant will be randomly assigned to one of the six stimulation patterns to use at home for the study period. There is no control or placebo group; all participants receive an active DBS programming intervention. Receives: Other: Continuous; Other: Continuous + High Frequency Cycling; Other: High Frequency; Other: Microburst; Other: Scheduling; Other: Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fahn-Tolosa-Marín Tremor Rating Scale (FTM-TRS)
Measured: 3-Month post programming
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Apr 2028 (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.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-center, single-group assignment interventional study. All enrolled participants undergo a structured trial of six experimental DBS stimulation paradigms delivered through Chronos™ software. Participants are then randomized to one stimulation program for at-home use. There is no comparison group; all participants receive active intervention. Follow-up occurs at 4 weeks, 3 months, and optionally at 1 year to assess tremor response, durability of benefit, and safety.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Christopher Honey, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302867
- Sponsor's protocol ID
- H25-03800
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation in Treatment Resistant Essential Tremor in Early Habituation - Investigating Low and High Frequencies / Waveform Shaping / Pulse and Bursts / Combination Therapy in Deep Brain Stimulation Utilizing the Boston Scientific® Chronos™ Software
- ClinicalTrials.gov ID
- NCT07302867
- Acronym / sponsor ID
- H25-03800
- Conditions
- Essential Tremor
- Keywords
- Deep Brain Stimulation, Essential Tremor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 24 Dec 2025 (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.
The goal of this observational study is to learn whether a new way of programming Deep Brain Stimulation (DBS) can improve and maintain tremor control in adults with essential tremor (ET) who stopped responding to standard DBS therapy.
The main questions it aims to answer are:
- 1. Can advanced DBS settings, using varied stimulation patterns, frequencies, and pulses, restore tremor control in people with ET who lost benefit from standard Ventral Intermedius Deep Brain Stimulation (VIM-DBS)?
- 2. Do these advanced settings provide more stable, longer-lasting tremor improvement over time?
Researchers will compare six different stimulation settings to see if any of them can improve tremor symptoms when standard DBS programming no longer works.
Participants will:
- Complete a clinic visit where they try six different DBS stimulation settings using specialized Chronos software.
- Be randomly assigned to one of these settings to use at home.
- Receive a follow-up phone call at 4 weeks to check on symptoms and device use.
- Return to the clinic at 3 months for a full tremor evaluation.
- Have the option to return for an additional follow-up visit at 1 year.
This study will include 5 participants with essential tremor who previously lost benefit quickly after receiving standard VIM-DBS treatment.
Detailed description
- Purpose: To test whether new DBS programming patterns can restore and sustain tremor control in essential tremor (ET) patients who lose benefit quickly after standard Vim-DBS.
- Hypothesis: Novel stimulation paradigms - like high-frequency, microburst, cycling, and scheduling - can overcome early habituation and provide lasting tremor improvement.
- Justification: Some ET patients experience rapid loss of benefit despite correct DBS placement. Standard programming does not help them, creating a disabling condition. Advanced programming may offer a safe, non-surgical solution.
- Objectives:
- 1. Determine if Chronos™ software programs maintain tremor improvement beyond one month.
- 2. Assess safety, tolerability, and identify the most effective stimulation parameters.
- Research Design: Prospective, single-center cohort study of 5 early-habituating ET patients. Patients trial six stimulation paradigms in clinic, then are randomized to one program for home use. Follow-up occurs at 4 weeks, 3 months, and optionally 1 year.
- Statistical Analysis: Descriptive statistics due to small sample size. Outcomes include tremor ratings, patient-reported benefit, and recurrence of habituation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-center, single-group assignment interventional study. All enrolled participants undergo a structured trial of six experimental DBS stimulation paradigms delivered through Chronos™ software. Participants are then randomized to one stimulation program for at-home use. There is no comparison group; all participants receive active intervention. Follow-up occurs at 4 weeks, 3 months, and optionally at 1 year to assess tremor response, durability of benefit, and safety.
| Arm | Type | Receives |
|---|---|---|
| Single Experimental Arm | Experimental | Other: Continuous, Other: Continuous + High Frequency Cycling, Other: High Frequency, Other: Microburst, Other: Scheduling, Other: CyclingAll participants will test six different experimental DBS stimulation programs in the clinic using Chronos™ software. After trying all six programs, each participant will be randomly assigned to one of the six stimulation patterns to use at home for the study period. There is no control or placebo group; all participants receive an active DBS programming intervention. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with essential tremor who have undergone standard Vim-DBS surgery
- Demonstrated rapid (early) habituation to standard programming.
- Ability to provide informed consent and attend follow-up visits.
Key exclusion criteria (3 listed)
- Inability to attend programming visits.
- Cognitive or language impairment precluding consent.
- Other neurological conditions confounding tremor assessment.
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 |
|---|---|---|
| ContinuousDBS setting: 185 Hz, 60 µs pulse width, optimized amplitude | Other | Single Experimental Arm |
| Continuous + High Frequency CyclingDBS setting: Alternates 30s at 185 Hz and 30s at 1000 Hz | Other | Single Experimental Arm |
| High FrequencyDBS setting: 1000 Hz continuous, 60 µs, optimized amplitude | Other | Single Experimental Arm |
| MicroburstDBS setting: 900 Hz intraburst, 80 Hz interburst, 6 pulses per packet | Other | Single Experimental Arm |
| SchedulingDBS setting: Two or three effective programs on alternating schedules | Other | Single Experimental Arm |
| CyclingDBS setting: 30s on / 5s off cycle without ramp, subthreshold stimulation | Other | Single Experimental Arm |
Primary outcome
The Fahn-Tolosa-Marín Tremor Rating Scale (FTM-TRS)
Time frame: 3-Month post programming
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 24 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Essential Tremor
RecruitingObservational study
The Encora X1™ in a Real World Observational Study
Essential Tremor
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
Recruiting
Effects of Microelectrode-based Brain Stimulation in Humans
Essential Tremor, Parkinsons Disease (PD)
Active, not recruitingObservational study
Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor
Essential Tremor
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous, Continuous + High Frequency Cycling and High Frequency in people with Essential Tremor, run by University of British Columbia 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Dec 2025. 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?
Contact Danielle A Pietramala (604-875-4111 ext. 68396, danielle.pietram@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fahn-Tolosa-Marín Tremor Rating Scale (FTM-TRS) (time frame: 3-Month post programming). 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 24 Dec 2025.