Parkinson DiseaseNCT06259708
Using Low Intensity Focused Ultrasound to Modulate Deep Brain Areas for Tremor Control in Parkinson's Disease Patients.
A study testing Low intensity focused ultrasound in people with Parkinson Disease, run by University of British Columbia at 1 site in Canada.
Trial summary
Researchers have found that a treatment called Magnetic Resonance guided Focused Ultrasound (MRgFUS) can effectively reduce tremors in patients with essential tremor (ET) and Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Low intensity focused ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2024to 17 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Parkinson's disease
- Resting tremor score (MDS-UPDRS III 3.17 Rest Tremore Amplitude (RUE or LUE)) ≥ 2
- Between the ages of 40-80 years
- Hoehn and Yahr stage between 1-3 (mild to moderate PD) in the "ON" state
- Patients who are willing to have a partial (~8 cm diameter circular area above the ear) hair shaving.
Who cannot join
- Atypical Parkinsonism
- History of essential tremor
- Dementia preventing informed consent
- Change in Parkinson's medication with the last 2 weeks
- Neurological disease other than PD, including Alzheimer's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, a brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma
- Unstable medical conditions or serious disease/conditions (e.g., cancer undergoing active treatment, poorly controlled diabetes)
Show all 26Show fewer
- Concurrent treatment for PD with Duodopa
- Concurrent treatment for PD with deep brain stimulation (DBS)
- Thickness of the temporal bone < 7 mm
- Individuals should also not participate if they have any of the following contraindications for undergoing fMRI scanning:
- Cardiac pacemaker, wires, or defibrillator
- Metal in eye or orbit, including the history of any eye injury involving metal fragments and increased risk due to (history of) working as a metal worker (grinding, machining, or welding)
- Ferromagnetic aneurysm clip
- Possibility of pregnancy
- Artificial heart valve
- Ear or eye implant, including cochlear implant
- Brain aneurysm clip
- Implanted drug infusion pump
- Electrical stimulator to nerves or bones
- Coil, catheter, or filter in any blood vessel
- Orthopedic hardware (artificial joint, plate, screw, rod)
- Other metallic prostheses
- Shrapnel, bullets, or other metal fragments
- Surgery, piercings or tattoos (including tattooed eyeliner) in the last six weeks
- Medication releasing skin patches (i.e. nicotine, birth control, nitroglycerine)
- History of claustrophobia
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, DMCBH
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: Effectiveness of Targeting the Zona Incerta (ZI) for Tremor Control in Parkinson's Disease Patients
Researchers have found that a treatment called Magnetic Resonance guided Focused Ultrasound (MRgFUS) can effectively reduce tremors in patients with essential tremor (ET) and Parkinson's disease (PD). They noticed that ET patients initially responded better to the treatment than PD patients, but by the end of the treatment, both groups showed similar improvement. The study also suggested that targeting a specific area of the brain called the Zona Incerta (ZI) may be more beneficial for PD patients. Based on these findings, the investigators plan to use low-intensity focused ultrasound to directly modulate the ZI area and investigate the mechanisms of reduced tremors in PD patients. The investigators will also compare the effectiveness of this approach with the current target, the ventral intermediate nucleus (Vim) of the thalamus. The investigators will use a simulation model to determine the best ultrasound parameters for this new approach and will also examine the impact of the treatment on the brain's network activity using functional Magnetic Resonance Imaging. Success of this project may lay the foundation for finding a more effective target for MRgFUS treatment of PD tremor.
- Conditions
- Parkinson Disease
- Being tested
- Low intensity focused ultrasound
- Keywords
- Low intensity focused ultrasound, Parkinsons disease, Tremor, Zona incerta
- Medical subject headings
- Parkinson Disease, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity focused ultrasoundDevice
Sonication with low intensity focused ultrasound in two deep brain structures (ZI and Vim).
| Study group | Role | What they receive |
|---|---|---|
| Vim first | Experimental | Participants assigned to this arm get LIFU stimulation in the Vim before the ZI. Receives: Device: Low intensity focused ultrasound |
| ZI first | Experimental | Participants assigned to this arm get LIFU stimulation in the Vim before the ZI. Receives: Device: Low intensity focused ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor
Finger displacement (angle [deg]).
Measured: At 50Hz for 40 minutes 30 minutes after intervention
Tremor
Finger acceleration (mm/s^2)
Measured: At 50Hz for 40 minutes 30 minutes after intervention
Functional connectivity
fMRI
Measured: Once before and once immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Mar 2024
- Primary completion17 Jun 2025
- Study completion17 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators will use a crossover design for this study as it requires fewer participants and removes variance between participants in the outcomes that are irrelevant to the stimulation type in comparison to other designs where each participant only receives one stimulation. All participants receive all the stimulation types (Vim-LIFU and ZI-LIFU), but the order in which they get the stimulation types is randomized.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Focused Ultrasound Foundation
- Responsible party
- Principal investigator, Martin McKeown, University of British Columbia
- Investigators
- Hongchae Baek, PhD, Principal investigator, Food and Drugs AdministrationSoojin Lee, PhD, Principal investigator, University of British ColumbiaMartin J. McKeown, MD, FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259708
- Sponsor's protocol ID
- H23-00480
- Status last verified
- Apr 2026
- First submitted
- 26 Jan 2024
- Last updated
- 30 Apr 2026
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Targeting the Zona Incerta (ZI) for Tremor Control in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT06259708
- Acronym / sponsor ID
- H23-00480
- Conditions
- Parkinson Disease
- Keywords
- Low intensity focused ultrasound, Parkinsons disease, Tremor, Zona incerta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Focused Ultrasound Foundation
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 14 Feb 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.
Researchers have found that a treatment called Magnetic Resonance guided Focused Ultrasound (MRgFUS) can effectively reduce tremors in patients with essential tremor (ET) and Parkinson's disease (PD). They noticed that ET patients initially responded better to the treatment than PD patients, but by the end of the treatment, both groups showed similar improvement. The study also suggested that targeting a specific area of the brain called the Zona Incerta (ZI) may be more beneficial for PD patients. Based on these findings, the investigators plan to use low-intensity focused ultrasound to directly modulate the ZI area and investigate the mechanisms of reduced tremors in PD patients. The investigators will also compare the effectiveness of this approach with the current target, the ventral intermediate nucleus (Vim) of the thalamus. The investigators will use a simulation model to determine the best ultrasound parameters for this new approach and will also examine the impact of the treatment on the brain's network activity using functional Magnetic Resonance Imaging. Success of this project may lay the foundation for finding a more effective target for MRgFUS treatment of PD tremor.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will use a crossover design for this study as it requires fewer participants and removes variance between participants in the outcomes that are irrelevant to the stimulation type in comparison to other designs where each participant only receives one stimulation. All participants receive all the stimulation types (Vim-LIFU and ZI-LIFU), but the order in which they get the stimulation types is randomized.
| Arm | Type | Receives |
|---|---|---|
| Vim first | Experimental | Device: Low intensity focused ultrasoundParticipants assigned to this arm get LIFU stimulation in the Vim before the ZI. |
| ZI first | Experimental | Device: Low intensity focused ultrasoundParticipants assigned to this arm get LIFU stimulation in the Vim before the ZI. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of Parkinson's disease
- Resting tremor score (MDS-UPDRS III 3.17 Rest Tremore Amplitude (RUE or LUE)) ≥ 2
- Between the ages of 40-80 years
- Hoehn and Yahr stage between 1-3 (mild to moderate PD) in the "ON" state
- Patients who are willing to have a partial (~8 cm diameter circular area above the ear) hair shaving.
Key exclusion criteria (26 listed)
- Atypical Parkinsonism
- History of essential tremor
- Dementia preventing informed consent
- Change in Parkinson's medication with the last 2 weeks
- Neurological disease other than PD, including Alzheimer's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, a brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma
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 |
|---|---|---|
| Low intensity focused ultrasoundSonication with low intensity focused ultrasound in two deep brain structures (ZI and Vim). | Device | Vim first, ZI first |
Primary outcome
Tremor
Time frame: At 50Hz for 40 minutes 30 minutes after intervention
Finger displacement (angle [deg]).
Tremor
Time frame: At 50Hz for 40 minutes 30 minutes after intervention
Finger acceleration (mm/s^2)
Functional connectivity
Time frame: Once before and once immediately after intervention
fMRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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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. This study is not recruiting at the moment.
Hongchae Baek, PhD principal investigator
Food and Drugs Administration
Soojin Lee, PhD principal investigator
University of British Columbia
Martin J. McKeown, MD, FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity focused ultrasound in people with Parkinson Disease, 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 5 inclusion and 26 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: finished, as of the sponsor's last update on 30 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremor (time frame: At 50Hz for 40 minutes 30 minutes after intervention). The study lists 3 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 30 Apr 2026.