Parkinson Disease (PD)PD GPi-TUSNCT07846007
Effects of Excitatory and Inhibitory LIFUS of GPi in Parkinsonian Patients Without DBS
A study testing LIFUS: Active 5 Hz Theta Burst and LIFUS: Active 10 Hz in people with Parkinson Disease (PD), run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Low intensity focused ultrasound (LIFUS) is a novel non-invasive brain stimulation (NIBS) technique that permits stimulation with high spatial focality and can reach greater depth compared other methods. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- LIFUS: Active 5 Hz Theta Burst and LIFUS: Active 10 Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 14 Feb 2024to Dec 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-90 years of age
- Confirmed diagnosis of Parkinson's disease
- Stable dopaminergic medication dose for a minimum of 4 weeks
Who cannot join
- History of stroke or seizure
- Comorbid dementia
- Scored below 22 on the Montreal Cognitive Assessment (MoCA)
- Has intracranial implant(s) or device(s)
- Has an implanted cardiac pacemaker or implantable cardioverter-defibrillator (ICD)
- Has a previous surgical intervention to treat the movement disorder such as lesioning or a Deep Brain Stimulation system in place.
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- Presence of metal implanted in body that is contraindicated in TMS/MRI/peripheral electrical stimulation
- Pregnancy
- Major depression/psychiatric disorder that in the opinion of the Investigator will affect patient's understanding of study procedures and willingness to abide by all procedures during the course of the study
- Is on antipsychotics, anti-depressants, marijuana, or other recreational drugs that affect the nervous system
- Major musculoskeletal or neuromuscular disease or disorder of the hands, wrists and limbs
- Severe Dyskinesia
- Major systemic illness or infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Regina Annirood contact
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T2S8
Julian Kwok, 416-603-5800 ext. 2708, julian.kwok@uhn.ca
About this study
Low intensity focused ultrasound (LIFUS) is a novel non-invasive brain stimulation (NIBS) technique that permits stimulation with high spatial focality and can reach greater depth compared other methods. This study will look at the effects of two different LIFUS stimulations on task performance in patients with Parkinson's disease. The effects of real stimulation will also be compared to sham stimulation. The evaluations will include behavioral tasks on the computer, the Unified Parkinson's Disease Rating Scale (UPDRS) motor scoring, and finger accelerometry recordings. These will be done before the LIFUS simulations and repeated after. This is to evaluate the different mechanisms and efficacy of these stimulations on deep brain areas.
Read the detailed description
The goal of this study is to evaluate the effects of two different deep brain LIFUS protocols on task performance in PD patients. We will use two different protocols (5 Hz theta Burst vs 10 Hz inhibitory), bilaterally on the GPi of PD patients in two different sessions and evaluate their performance in visuomotor tasks using stop signal paradigm. We will also use active sham in a separate session bilaterally on the occipital cortex, more specifically Brodmann area 19 to compare differences in tremor activity. We will record behavioral performance of the patients to disentangle effects of different TUS protocols on PD patients. We will also use finger accelerometer on the tremor dominant hand, to evaluate possible changes in tremor.
For each participant, there will be four visits. In the first visit, a structural MRI scan will be obtained. In the subsequent three visits, the LIFUS experiments including the behavioral tasks on the computer, UPDRS motor scoring, and finger accelerometry recordings will be conducted in random order. In these visits, the task performance (stop-signal task) will be recorded before and after applying the 3 different LIFUS paradigms: 1) theta burst TUS of the GPi in one session, 2) 10Hz TUS of the GPi in one session, and 3) active sham condition in the occipital cortex (bilateral) where we will use theta burst LIFUS to the Brodmann area 19 at a TPO distance of ~30mm. Visits 2, 3, and 4 will be separated by at least 1 week each and theta burst TUS (2 minutes x2 =4 min), 10 Hz protocol (Burst length 30ms, period 1000, 30% dc. Total Time: 40 seconds x2= 80 seconds) and sham theta bust TUS will be tested in random order.
- Conditions
- Parkinson Disease (PD)
- Being tested
- LIFUS: Active 5 Hz Theta Burst, LIFUS: Active 10 Hz, LIFUS: Sham
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFUS: Active 5 Hz Theta BurstDevice
LIFUS 5 Hz theta burst bilaterally on the GPi
LIFUS: Active 10 HzDevice
LIFUS 10 Hz bilaterally on the GPi
LIFUS: ShamDevice
Sham: LIFUS theta burst to occipital lobe
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity Focused Ultrasound | Experimental | 3 different LIFUS paradigms in random order: 1) theta burst TUS of the GPi in one session, 2) 10Hz TUS of the GPi in one session, and 3) active sham condition in the occipital cortex (bilateral) where we will use theta burst LIFUS to the Brodmann area 19 at a TPO distance of ~30mm. Receives: Device: LIFUS: Active 5 Hz Theta Burst; Device: LIFUS: Active 10 Hz; Device: LIFUS: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stop-Signal Task
Measured: Visits 2-4: before stimulation, 20 minutes post round 1 of stimulation, and 25 minutes post round 2 of stimulation
Secondary outcomes (3)
Unified Parkinsons Disease Rating Scale (UPDRS)
Part III - Motor Assessment
Measured: Visits 2-4: At the beginning of the visit, and at the end of the visit after all stimulation. Visits 2-4 will take place over at least 3 weeks as each visit is at least 1 week apart.
Rest Tremor
Resting tremor will be measured by an accelerometer
Measured: Visits 2-4: resting tremor will be recorded by an accelerometer periodically during each visit. This will be over at least 3 weeks, since each visit is at least 1 week apart.
Postural Tremor
Postural tremor will be measured as arms are outstretched using an accelerometer
Measured: Visit 2 - 4. At each visit, it will be recorded twice. Once before the stimulation and another after. This will take place over at least 3 weeks, since each visit is at least 1 week apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start14 Feb 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants are randomized on the order of stimulation that they receive. However, all participants will receive the 2 active LIFUS stimulations and the 1 sham/placebo LIFUS stimulation.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Chen, University Health Network, Toronto
- Investigators
- Robert Chen, MBBS, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846007
- Sponsor's protocol ID
- 20-5740#5
- Acronym
- PD GPi-TUS
- Status last verified
- Sep 2026
- First submitted
- 22 Feb 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Excitatory and Inhibitory LIFUS of GPi in Parkinsonian Patients Without DBS
- ClinicalTrials.gov ID
- NCT07846007
- Acronym / sponsor ID
- PD GPi-TUS / 20-5740#5
- Conditions
- Parkinson Disease (PD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Sep 2026 (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.
Low intensity focused ultrasound (LIFUS) is a novel non-invasive brain stimulation (NIBS) technique that permits stimulation with high spatial focality and can reach greater depth compared other methods. This study will look at the effects of two different LIFUS stimulations on task performance in patients with Parkinson's disease. The effects of real stimulation will also be compared to sham stimulation. The evaluations will include behavioral tasks on the computer, the Unified Parkinson's Disease Rating Scale (UPDRS) motor scoring, and finger accelerometry recordings. These will be done before the LIFUS simulations and repeated after. This is to evaluate the different mechanisms and efficacy of these stimulations on deep brain areas.
Detailed description
The goal of this study is to evaluate the effects of two different deep brain LIFUS protocols on task performance in PD patients. We will use two different protocols (5 Hz theta Burst vs 10 Hz inhibitory), bilaterally on the GPi of PD patients in two different sessions and evaluate their performance in visuomotor tasks using stop signal paradigm. We will also use active sham in a separate session bilaterally on the occipital cortex, more specifically Brodmann area 19 to compare differences in tremor activity. We will record behavioral performance of the patients to disentangle effects of different TUS protocols on PD patients. We will also use finger accelerometer on the tremor dominant hand, to evaluate possible changes in tremor.
For each participant, there will be four visits. In the first visit, a structural MRI scan will be obtained. In the subsequent three visits, the LIFUS experiments including the behavioral tasks on the computer, UPDRS motor scoring, and finger accelerometry recordings will be conducted in random order. In these visits, the task performance (stop-signal task) will be recorded before and after applying the 3 different LIFUS paradigms: 1) theta burst TUS of the GPi in one session, 2) 10Hz TUS of the GPi in one session, and 3) active sham condition in the occipital cortex (bilateral) where we will use theta burst LIFUS to the Brodmann area 19 at a TPO distance of ~30mm. Visits 2, 3, and 4 will be separated by at least 1 week each and theta burst TUS (2 minutes x2 =4 min), 10 Hz protocol (Burst length 30ms, period 1000, 30% dc. Total Time: 40 seconds x2= 80 seconds) and sham theta bust TUS will be tested in random order.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants are randomized on the order of stimulation that they receive. However, all participants will receive the 2 active LIFUS stimulations and the 1 sham/placebo LIFUS stimulation.
| Arm | Type | Receives |
|---|---|---|
| Low Intensity Focused Ultrasound | Experimental | Device: LIFUS: Active 5 Hz Theta Burst, Device: LIFUS: Active 10 Hz, Device: LIFUS: Sham3 different LIFUS paradigms in random order: 1) theta burst TUS of the GPi in one session, 2) 10Hz TUS of the GPi in one session, and 3) active sham condition in the occipital cortex (bilateral) where we will use theta burst LIFUS to the Brodmann area 19 at a TPO distance of ~30mm. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-90 years of age
- Confirmed diagnosis of Parkinson's disease
- Stable dopaminergic medication dose for a minimum of 4 weeks
Key exclusion criteria (13 listed)
- History of stroke or seizure
- Comorbid dementia
- Scored below 22 on the Montreal Cognitive Assessment (MoCA)
- Has intracranial implant(s) or device(s)
- Has an implanted cardiac pacemaker or implantable cardioverter-defibrillator (ICD)
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 |
|---|---|---|
| LIFUS: Active 5 Hz Theta BurstLIFUS 5 Hz theta burst bilaterally on the GPi | Device | Low Intensity Focused Ultrasound |
| LIFUS: Active 10 HzLIFUS 10 Hz bilaterally on the GPi | Device | Low Intensity Focused Ultrasound |
| LIFUS: ShamSham: LIFUS theta burst to occipital lobe | Device | Low Intensity Focused Ultrasound |
Primary outcome
Stop-Signal Task
Time frame: Visits 2-4: before stimulation, 20 minutes post round 1 of stimulation, and 25 minutes post round 2 of stimulation
3 secondary outcomes
Unified Parkinsons Disease Rating Scale (UPDRS)
Time frame: Visits 2-4: At the beginning of the visit, and at the end of the visit after all stimulation. Visits 2-4 will take place over at least 3 weeks as each visit is at least 1 week apart.
Rest Tremor
Time frame: Visits 2-4: resting tremor will be recorded by an accelerometer periodically during each visit. This will be over at least 3 weeks, since each visit is at least 1 week apart.
Postural Tremor
Time frame: Visit 2 - 4. At each visit, it will be recorded twice. Once before the stimulation and another after. This will take place over at least 3 weeks, since each visit is at least 1 week apart.
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 29 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Regina Annirood contact
Robert Chen, MBBS principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIFUS: Active 5 Hz Theta Burst and LIFUS: Active 10 Hz in people with Parkinson Disease (PD), run by University Health Network, Toronto 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 13 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 29 Sep 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?
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 Julian Kwok (416-603-5800 ext. 2708, julian.kwok@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stop-Signal Task (time frame: Visits 2-4: before stimulation, 20 minutes post round 1 of stimulation, and 25 minutes post round 2 of stimulation). 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 29 Sep 2026.