Parkinson DiseaseFREEDOMNCT07764874
Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease.
A study testing Unilateral Exablate MRgFUS Pallidothalamic Tractotomy, Staged Bilateral Exablate Pallidothalamic Tractotomy and Best Medical Treatment (BMT) in people with Parkinson Disease, run by InSightec at 1 site in South Korea.
Trial summary
This study is a randomized clinical trial evaluating a focused ultrasound treatment for people with advanced Parkinson's disease (PD) who have disabling motor complications and symptoms. The study uses the Exablate Neuro System, which delivers MR-guided Focused Ultrasound (MRgFUS). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Unilateral Exablate MRgFUS Pallidothalamic Tractotomy, Staged Bilateral Exablate Pallidothalamic Tractotomy and Best Medical Treatment (BMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2026to Jun 2031
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women, age 30 years and older
- Subject is able and willing to give informed consent and able to attend all study visits
- Subject with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
- Subject is interested in receiving bilateral treatment if they qualify.
- Subject is Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state.
- Subject has MDS-UPDRS Part III OFF ULE score of ≥ 15 on each side in the meds OFF condition.
Show all 10Show fewer
- Subject experiencing motor complications of PD on optimum medical treatment characterized by dyskinesia (MDS-UPDRS item 4.2 score of ≥ 2) OR Motor fluctuations (MDS-UPDRS item 4.4 score of ≥ 2)
- Subject is on a stable dose of all PD medications for 30 days prior to screening visit PD assessments as determined by medical records
- Subject is able to communicate sensations during the Exablate procedure.
- Subject's pallidothalamic region can be targeted by the Exablate device.
Who cannot join
- Subject with severe premorbid risks as specified in the MDS-UPDRS Part II subsection motor aspects of experiences of daily living scores:
- 3 or 4 on question 2.1 (speech) OR
- 3 or 4 on question 2.3 (chewing and swallowing) OR
- 4 on question 2.2 (saliva and drooling).
- Subject where there is suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
- Subject has an MMSE score < 24.
Show all 29Show fewer
- Subject has other central neurodegenerative disease suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease.
- Subject with unstable psychiatric disease, uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation.
- Female subject who is pregnant.
- Female subject of childbearing potential not willing to use contraceptives throughout the duration of the study (~ 24 months)
- Subject exhibiting any behavior(s) consistent with ethanol or substance abuse.
- Subject with unstable cardiac status or severe hypertension.
- Subject with history of abnormal bleeding, hemorrhage, or coagulopathy.
- Subject with cerebrovascular disease.
- Subject is receiving anticoagulant (e.g., warfarin) or antiplatelet (e.g., aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g., Avastin) within one month of focused ultrasound procedure.
- Subject with advanced kidney disease or on dialysis.
- Subject with a history of seizures within the past year.
- Subject with a brain tumor.
- Subject with life-threatening systemic disease (e.g. HIV, liver failure, blood dyscrasias, etc.).
- Subject with any illness that in the investigator's opinion precludes participation in this study.
- Subject with standard contraindications for MR imaging such as implanted metallic devices.
- Subject who had prior deep brain stimulation of the basal ganglia or thalamus.
- Subject who is unable to tolerate the required prolonged stationary supine position during treatment.
- Subject who has an Overall Skull Density Ratio of less than 0.40 as calculated from the screening CT (if this is the only exclusion, subject can participate in the study as part of the reference group).
- Subject who is participating in another clinical investigation with an active treatment arm
- Subject who is unable to communicate with the investigator and staff.
- Subject who is in a nursing home in the last 30 days.
- Additional Exclusion Criteria for Staged Bilateral PTT procedure
- Clinically significant neurological event of dysphagia, abnormal speech function, or gait abnormalities that are moderate to severe following first procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Korea University Anam Hospital
Seoul
Kyoungwon Baik, +82-10-6620-8492, baikkw88@gmail.com
Kyoungwon Baik
About this study
Official title: An MR Guided Focused Ultrasound (MRgFUS) Randomized Trial Using the Exablate Neuro System to Assess the Effectiveness and Safety Outcomes of Unilateral and Staged Bilateral Ablation in the Subthalamic Region Involving the Pallidothalamic Tract (PTT) in Advanced Parkinson's Disease (PD) With Motor Complications.
This study is a randomized clinical trial evaluating a focused ultrasound treatment for people with advanced Parkinson's disease (PD) who have disabling motor complications and symptoms.
The study uses the Exablate Neuro System, which delivers MR-guided Focused Ultrasound (MRgFUS). This technology focuses ultrasound energy on a specific brain target and generates heat to create a small lesion (ablation) without making a surgical incision.
Read more
The target in this study is the Pallidothalamic Tract (PTT), a pathway involved in the abnormal brain circuits that contribute to Parkinson's symptoms and complications.
This study is evaluating whether treating one side of the brain or treating both sides (in separate procedures) provides better outcomes for people with advanced Parkinson's disease who have motor complications and symptoms.
The main outcome measure is the change in the MDS-UPDRS Part III Upper/Lower Extremity (ULE) score at 3 months after first and second side treatment, compared with the respective control groups.
MDS-UPDRS Part III is a standard clinical scale used to assess Parkinson's motor symptoms. ULE score focuses on motor function in the arms and legs. Assessments are performed in the OFF-medication state, meaning Parkinson's medications are temporarily withheld so that the treatment effect can be measured more accurately.
In addition improvement in motor complications will be assessed with MDS-UPDRS Part IV and Patient diaries.
Read the detailed description
A Post Approval Study (US) / Pre Market Extension Study (Outside US), international prospective, multi-center, assessor-blinded, two-stage (2:1) randomized controlled trial evaluating successive Exablate treatment (first and second side) versus BMT (Best Medical Treatment).
In individuals eligible for the staged, bilateral Exablate PTT procedure, building on evidence from the predicate pivotal staged bilateral study that led to PMA approval in the United States, this trial aims to evaluate the successive treatment of 1st and 2nd side Exablate PTT ablation using a two-stage randomized controlled design. In Stage 1, patients will be randomized to receive either 1st side PTT procedure or best medical treatment (BMT). Patients who initially randomized to receive BMT will cross over to receive 1st side PTT procedure after 3 months (if they still qualify for the treatment). All patients will continue to be followed through a 6-month period post 1st side treatment. All eligible patients who reach Stage 2 will be re-randomized to undergo 2nd side PTT procedure or continue with BMT. Patients randomized to receive BMT in stage 2 will cross over to receive 2nd side PTT procedure after 3 months (if they still qualify for the treatment). All patients will continue to be followed through a 12-month period post 2nd side treatment. This design enables evaluation between staged-bilateral treatment, unilateral treatment alone, and standard of care (SOC)/BMT medical therapy. This study will generate real-world comparative data to better inform decision-makers about the generalizability in subthalamic region ablations involving the PTT. Outcomes will be assessed using relevant lateralized Parkinson-specific clinical scales, measures of functional impairment, disease-specific quality of life, adverse events, and patient-reported perceptions of overall treatment effectiveness.
- Conditions
- Parkinson Disease
- Being tested
- Unilateral Exablate MRgFUS Pallidothalamic Tractotomy, Staged Bilateral Exablate Pallidothalamic Tractotomy, Best Medical Treatment (BMT)
- Keywords
- Exablate, MRgFUS, Pallidothalamic Tract
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral Exablate MRgFUS Pallidothalamic TractotomyDevice
1st side Exablate MRgFUS Pallidothalamic Tractotomy for Parkinson's Disease
Staged Bilateral Exablate Pallidothalamic TractotomyDevice
2nd side staged Exablate MRgFUS Pallidothalamic Tractotomy for Parkinson's Disease
Best Medical Treatment (BMT)Drug
Subjects will be managed according to conventional therapeutic guidelines (i.e., best medical treatment) for Parkinson's Disease
| Study group | Role | What they receive |
|---|---|---|
| Active Group 1_Unilateral Exablate Pallidothalamic Tractotomy | Experimental | Subjects will undergo the 1st side Exablate procedure (< 30 days after randomization) and will be followed for 6 months. At their Month 6 visit, subjects will have their re-baseline assessment and undergo staged randomization for the 2nd side treatment. Receives: Device: Unilateral Exablate MRgFUS Pallidothalamic Tractotomy |
| Control Group 1_Best Medical Treatment (BMT) | Active comparator | Subjects will have their standard of care (SOC) treatment adjusted to best effect (BMT), and will be followed for 3 months. After their Month 3 visit, subjects will cross over to receive the 1st side treatment and be followed for 6 months. At their Month 6 visit, subjects will have their Treatment 2 re-baseline assessment and undergo staged randomization for the 2nd side treatment. Receives: Drug: Best Medical Treatment (BMT) |
| Active Group 2_Staged Bilateral Exablate Pallidothalamic Tractotomy | Experimental | Subjects will undergo the 2nd side Exablate procedure (< 30 days after re-baseline assessment, and will be followed for 12 months. Receives: Device: Unilateral Exablate MRgFUS Pallidothalamic Tractotomy; Device: Staged Bilateral Exablate Pallidothalamic Tractotomy |
| Control Group 2_BMT after Unilateral Exablate Pallidothalamic Tractotomy | Active comparator | Subjects will continue with their SOC BMT and will be followed for 3 months. After their Month 3 visit, subjects will cross over to receive the 2nd side treatment and be followed for 12 months. Receives: Device: Unilateral Exablate MRgFUS Pallidothalamic Tractotomy; Drug: Best Medical Treatment (BMT) |
| Reference Group_BMT with low SDR | Active comparator | Subjects will be offered the option to receive best medical treatment and will be followed to capture natural disease progression at approximately the same time schedule as patients in the randomized groups (~ every 3 - 6 months for up to 24 months). Receives: Drug: Best Medical Treatment (BMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDS-UPRDS Part III ULE score in the OFF-medication (unilateral treatment)
Between-group difference (Active Group 1 vs. Control Group 1) in the treatment effect (point change) in the MDS-UPRDS Part III ULE score in the OFF-medication state from Baseline to 3 month.
This assessment will be performed by a Movement Disorders neurologist blinded to patient study group allocation.
Measured: 3 Months
MDS-UPRDS Part III ULE score in the OFF-medication (bilateral treatment)
Between-group difference (Active Group 2 vs. Control Group 2) in the treatment effect (point change) in the MDS-UPRDS Part III ULE score in the OFF-medication state from Baseline to 3 month.
This assessment will be performed by a Movement Disorders neurologist blinded to patient study group allocation.
Measured: 3 Months
Secondary outcomes (9)
MDS-UPDRS III Total score in the OFF-medication state
Between-group comparison (Active Group 1 vs Control Group 1) of the treatment effect at Month 3 following Treatment 1 (unilateral) and within-group comparison (Active Group 1) of the treatment effect at all study visits (Month 1, 3 and 6) following Treatment 1 compared to baseline.
Between-group comparison (Active Group 2 vs Control Group 2) of the treatment effect at Month 3 following Treatment 2 (staged bilateral) and within-group comparison (Active Group 2) of the treatment effect at all study visits (Month 1, 3, 6 and 12) following Treatment 2 compared to baseline.
Measured: 1 Month, 3 Months, 6 Months, 12 Months
MDS-UPDRS Part III OFF ULE score
Between-group comparison (Active Group 1 vs Control Group 1) of the treatment effect at Month 3 following Treatment 1 (unilateral) and within-group comparison (Active Group 1) of the treatment effect at all study visits (Month 1, 3 and 6) following Treatment 1 compared to baseline.
Between-group comparison (Active Group 2 vs Control Group 2) of the treatment effect at Month 3 following Treatment 2 (staged bilateral) and within-group comparison (Active Group 2) of the treatment effect at all study visits (Month 1, 3, 6 and 12) following Treatment 2 compared to baseline.
Measured: 1 Month, 3 Months, 6 Months, 12 Months
MDS-UPDRS Part III ON Total score
Between-group comparison (Active Group 1 vs Control Group 1) of the treatment effect at Month 3 following Treatment 1 (unilateral) and within-group comparison (Active Group 1) of the treatment effect at all study visits (Month 1, 3 and 6) following Treatment 1 compared to baseline.
Between-group comparison (Active Group 2 vs Control Group 2) of the treatment effect at Month 3 following Treatment 2 (staged bilateral) and within-group comparison (Active Group 2) of the treatment effect at all study visits (Month 1, 3, 6 and 12) following Treatment 2 compared to baseline.
Measured: 1 Month, 3 Months, 6 Months, 12 Months
MDS-UPDRS Part IV Total score
Between-group comparison (Active Group 1 vs Control Group 1) of the treatment effect at Month 3 following Treatment 1 (unilateral) and within-group comparison (Active Group 1) of the treatment effect at all study visits (Month 1, 3 and 6) following Treatment 1 compared to baseline.
Between-group comparison (Active Group 2 vs Control Group 2) of the treatment effect at Month 3 following Treatment 2 (staged bilateral) and within-group comparison (Active Group 2) of the treatment effect at all study visits (Month 1, 3, 6 and 12) following Treatment 2 compared to baseline.
Measured: 1 Month, 3 Months, 6 Months, 12 Months
Number of hours per day in ON time without troublesome dyskinesia- as measured by patient diaries (unilateral)
Between-group comparison (Active Group 1 vs Control Group 1) of the treatment effect at Month 3 following Treatment 1 (unilateral) and within-group comparison (Active Group 1) of the treatment effect at all study visits (Month 1, 3 and 6) following Treatment 1 compared to baseline.
Between-group comparison (Active Group 2 vs Control Group 2) of the treatment effect at Month 3 following Treatment 2 (staged bilateral) and within-group comparison (Active Group 2) of the treatment effect at all study visits (Month 1, 3, 6 and 12) following Treatment 2 compared to baseline.
Measured: 1 Month, 3 Months, 6 Months, 12 Months
Number of hours per day in the OFF time as measured by patient diaries (unilateral)
Between-group comparison (Active Group 1 vs Control Group 1) of the treatment effect at Month 3 following Treatment 1 (unilateral) and within-group comparison (Active Group 1) of the treatment effect at all study visits (Month 1, 3 and 6) following Treatment 1 compared to baseline.
Between-group comparison (Active Group 2 vs Control Group 2) of the treatment effect at Month 3 following Treatment 2 (staged bilateral) and within-group comparison (Active Group 2) of the treatment effect at all study visits (Month 1, 3, 6 and 12) following Treatment 2 compared to baseline.
Measured: 1 Month, 3 Months, 6 Months, 12 Months
Number of hours per day with troublesome dyskinesia (unilateral)
Between-group comparison (Active Group 1 vs Control Group 1) of the treatment effect at Month 3 following Treatment 1 (unilateral) and within-group comparison (Active Group 1) of the treatment effect at all study visits (Month 1, 3 and 6) following Treatment 1 compared to baseline.
Between-group comparison (Active Group 2 vs Control Group 2) of the treatment effect at Month 3 following Treatment 2 (staged bilateral) and within-group comparison (Active Group 2) of the treatment effect at all study visits (Month 1, 3, 6 and 12) following Treatment 2 compared to baseline.
Measured: 1 Month, 3 Months, 6 Months, 12 Months
Quality of Life as measured by PDQ-39 (unilateral)
Between-group comparison (Active Group 1 vs Control Group 1) of the treatment effect at Month 3 following Treatment 1 (unilateral) and within-group comparison (Active Group 1) of the treatment effect at all study visits (Month 1, 3 and 6) following Treatment 1 compared to baseline.
Between-group comparison (Active Group 2 vs Control Group 2) of the treatment effect at Month 3 following Treatment 2 (staged bilateral) and within-group comparison (Active Group 2) of the treatment effect at all study visits (Month 1, 3, 6 and 12) following Treatment 2 compared to baseline.
Measured: 1 Month, 3 Months, 6 Months, 12 Months
Levodopa equivalent dose change usage (milligrams) (unilateral)
Between-group comparison (Active Group 1 vs Control Group 1) of the treatment effect at Month 3 following Treatment 1 (unilateral) and within-group comparison (Active Group 1) of the treatment effect at all study visits (Month 1, 3 and 6) following Treatment 1 compared to baseline.
Between-group comparison (Active Group 2 vs Control Group 2) of the treatment effect at Month 3 following Treatment 2 (staged bilateral) and within-group comparison (Active Group 2) of the treatment effect at all study visits (Month 1, 3, 6 and 12) following Treatment 2 compared to baseline.
Measured: 1 Month, 3 Months, 6 Months, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionJun 2031 (estimated)
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.
- 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
- Randomised
- Intervention model
- Sequential
- Model description
- This is a 2-stage randomized controlled trial. Stage 1: Subjects will be randomized (2:1) for treatment on one side of the brain vs. BMT for 3 months before being allowed to receive treatment on the 1st side (if eligible). Stage 2: After 6 months post-1st side treatment (and confirmation that they are still eligible to receive their 2nd side treatment), patients will be randomized (2:1) again for treatment on the 2nd side of the brain vs. BMT for 3 months before being allowed to receive treatment on the 2nd side (if eligible). Patients fulfilling all inclusion/exclusion criteria except for the SDR (skull density ratio) requirements (and so anatomically not able to undergo MRgFUS) will be offered the option to receive best medical treatment and will be formally followed as a reference comparator for up to 2 years.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joohi Jimenez-shahed, MD, Principal investigator, Mount Sinai, Clinical Neurosciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764874
- Sponsor's protocol ID
- PD018
- Acronym
- FREEDOM
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An MR Guided Focused Ultrasound (MRgFUS) Randomized Trial Using the Exablate Neuro System to Assess the Effectiveness and Safety Outcomes of Unilateral and Staged Bilateral Ablation in the Subthalamic Region Involving the Pallidothalamic Tract (PTT) in Advanced Parkinson's Disease (PD) With Motor Complications.
- ClinicalTrials.gov ID
- NCT07764874
- Acronym / sponsor ID
- FREEDOM / PD018
- Conditions
- Parkinson Disease
- Keywords
- Exablate, MRgFUS, Pallidothalamic Tract
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 14 Aug 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.
This study is a randomized clinical trial evaluating a focused ultrasound treatment for people with advanced Parkinson's disease (PD) who have disabling motor complications and symptoms.
The study uses the Exablate Neuro System, which delivers MR-guided Focused Ultrasound (MRgFUS). This technology focuses ultrasound energy on a specific brain target and generates heat to create a small lesion (ablation) without making a surgical incision.
The target in this study is the Pallidothalamic Tract (PTT), a pathway involved in the abnormal brain circuits that contribute to Parkinson's symptoms and complications.
This study is evaluating whether treating one side of the brain or treating both sides (in separate procedures) provides better outcomes for people with advanced Parkinson's disease who have motor complications and symptoms.
The main outcome measure is the change in the MDS-UPDRS Part III Upper/Lower Extremity (ULE) score at 3 months after first and second side treatment, compared with the respective control groups.
MDS-UPDRS Part III is a standard clinical scale used to assess Parkinson's motor symptoms. ULE score focuses on motor function in the arms and legs. Assessments are performed in the OFF-medication state, meaning Parkinson's medications are temporarily withheld so that the treatment effect can be measured more accurately.
In addition improvement in motor complications will be assessed with MDS-UPDRS Part IV and Patient diaries.
Detailed description
A Post Approval Study (US) / Pre Market Extension Study (Outside US), international prospective, multi-center, assessor-blinded, two-stage (2:1) randomized controlled trial evaluating successive Exablate treatment (first and second side) versus BMT (Best Medical Treatment).
In individuals eligible for the staged, bilateral Exablate PTT procedure, building on evidence from the predicate pivotal staged bilateral study that led to PMA approval in the United States, this trial aims to evaluate the successive treatment of 1st and 2nd side Exablate PTT ablation using a two-stage randomized controlled design. In Stage 1, patients will be randomized to receive either 1st side PTT procedure or best medical treatment (BMT). Patients who initially randomized to receive BMT will cross over to receive 1st side PTT procedure after 3 months (if they still qualify for the treatment). All patients will continue to be followed through a 6-month period post 1st side treatment. All eligible patients who reach Stage 2 will be re-randomized to undergo 2nd side PTT procedure or continue with BMT. Patients randomized to receive BMT in stage 2 will cross over to receive 2nd side PTT procedure after 3 months (if they still qualify for the treatment). All patients will continue to be followed through a 12-month period post 2nd side treatment. This design enables evaluation between staged-bilateral treatment, unilateral treatment alone, and standard of care (SOC)/BMT medical therapy. This study will generate real-world comparative data to better inform decision-makers about the generalizability in subthalamic region ablations involving the PTT. Outcomes will be assessed using relevant lateralized Parkinson-specific clinical scales, measures of functional impairment, disease-specific quality of life, adverse events, and patient-reported perceptions of overall treatment effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- This is a 2-stage randomized controlled trial. Stage 1: Subjects will be randomized (2:1) for treatment on one side of the brain vs. BMT for 3 months before being allowed to receive treatment on the 1st side (if eligible). Stage 2: After 6 months post-1st side treatment (and confirmation that they are still eligible to receive their 2nd side treatment), patients will be randomized (2:1) again for treatment on the 2nd side of the brain vs. BMT for 3 months before being allowed to receive treatment on the 2nd side (if eligible). Patients fulfilling all inclusion/exclusion criteria except for the SDR (skull density ratio) requirements (and so anatomically not able to undergo MRgFUS) will be offered the option to receive best medical treatment and will be formally followed as a reference comparator for up to 2 years.
| Arm | Type | Receives |
|---|---|---|
| Active Group 1_Unilateral Exablate Pallidothalamic Tractotomy | Experimental | Device: Unilateral Exablate MRgFUS Pallidothalamic TractotomySubjects will undergo the 1st side Exablate procedure (< 30 days after randomization) and will be followed for 6 months. At their Month 6 visit, subjects will have their re-baseline assessment and undergo staged randomization for the 2nd side treatment. |
| Control Group 1_Best Medical Treatment (BMT) | Active comparator | Drug: Best Medical Treatment (BMT)Subjects will have their standard of care (SOC) treatment adjusted to best effect (BMT), and will be followed for 3 months. After their Month 3 visit, subjects will cross over to receive the 1st side treatment and be followed for 6 months. At their Month 6 visit, subjects will have their Treatment 2 re-baseline assessment and undergo staged randomization for the 2nd side treatment. |
| Active Group 2_Staged Bilateral Exablate Pallidothalamic Tractotomy | Experimental | Device: Unilateral Exablate MRgFUS Pallidothalamic Tractotomy, Device: Staged Bilateral Exablate Pallidothalamic TractotomySubjects will undergo the 2nd side Exablate procedure (< 30 days after re-baseline assessment, and will be followed for 12 months. |
| Control Group 2_BMT after Unilateral Exablate Pallidothalamic Tractotomy | Active comparator | Device: Unilateral Exablate MRgFUS Pallidothalamic Tractotomy, Drug: Best Medical Treatment (BMT)Subjects will continue with their SOC BMT and will be followed for 3 months. After their Month 3 visit, subjects will cross over to receive the 2nd side treatment and be followed for 12 months. |
| Reference Group_BMT with low SDR | Active comparator | Drug: Best Medical Treatment (BMT)Subjects will be offered the option to receive best medical treatment and will be followed to capture natural disease progression at approximately the same time schedule as patients in the randomized groups (~ every 3 - 6 months for up to 24 months). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men or women, age 30 years and older
- Subject is able and willing to give informed consent and able to attend all study visits
- Subject with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
- Subject is interested in receiving bilateral treatment if they qualify.
- Subject is Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state.
Key exclusion criteria (29 listed)
- Subject with severe premorbid risks as specified in the MDS-UPDRS Part II subsection motor aspects of experiences of daily living scores:
- Subject where there is suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
- Subject has an MMSE score < 24.
- Subject has other central neurodegenerative disease suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease.
- Subject with unstable psychiatric disease, uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation.
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 |
|---|---|---|
| Unilateral Exablate MRgFUS Pallidothalamic Tractotomy1st side Exablate MRgFUS Pallidothalamic Tractotomy for Parkinson's Disease | Device | Active Group 1_Unilateral Exablate Pallidothalamic Tractotomy, Active Group 2_Staged Bilateral Exablate Pallidothalamic Tractotomy, Control Group 2_BMT after Unilateral Exablate Pallidothalamic Tractotomy |
| Staged Bilateral Exablate Pallidothalamic Tractotomy2nd side staged Exablate MRgFUS Pallidothalamic Tractotomy for Parkinson's Disease | Device | Active Group 2_Staged Bilateral Exablate Pallidothalamic Tractotomy |
| Best Medical Treatment (BMT)Subjects will be managed according to conventional therapeutic guidelines (i.e., best medical treatment) for Parkinson's Disease | Drug | Control Group 1_Best Medical Treatment (BMT), Control Group 2_BMT after Unilateral Exablate Pallidothalamic Tractotomy, Reference Group_BMT with low SDR |
Primary outcome
MDS-UPRDS Part III ULE score in the OFF-medication (unilateral treatment)
Time frame: 3 Months
Between-group difference (Active Group 1 vs. Control Group 1) in the treatment effect (point change) in the MDS-UPRDS Part III ULE score in the OFF-medication state from Baseline to 3 month. This assessment will be performed by a Movement Disorders neurologist blinded to patient study group allocation.
MDS-UPRDS Part III ULE score in the OFF-medication (bilateral treatment)
Time frame: 3 Months
Between-group difference (Active Group 2 vs. Control Group 2) in the treatment effect (point change) in the MDS-UPRDS Part III ULE score in the OFF-medication state from Baseline to 3 month. This assessment will be performed by a Movement Disorders neurologist blinded to patient study group allocation.
9 secondary outcomes
MDS-UPDRS III Total score in the OFF-medication state
Time frame: 1 Month, 3 Months, 6 Months, 12 Months
MDS-UPDRS Part III OFF ULE score
Time frame: 1 Month, 3 Months, 6 Months, 12 Months
MDS-UPDRS Part III ON Total score
Time frame: 1 Month, 3 Months, 6 Months, 12 Months
MDS-UPDRS Part IV Total score
Time frame: 1 Month, 3 Months, 6 Months, 12 Months
Number of hours per day in ON time without troublesome dyskinesia- as measured by patient diaries (unilateral)
Time frame: 1 Month, 3 Months, 6 Months, 12 Months
Number of hours per day in the OFF time as measured by patient diaries (unilateral)
Time frame: 1 Month, 3 Months, 6 Months, 12 Months
Number of hours per day with troublesome dyskinesia (unilateral)
Time frame: 1 Month, 3 Months, 6 Months, 12 Months
Quality of Life as measured by PDQ-39 (unilateral)
Time frame: 1 Month, 3 Months, 6 Months, 12 Months
Levodopa equivalent dose change usage (milligrams) (unilateral)
Time frame: 1 Month, 3 Months, 6 Months, 12 Months
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 20 Oct 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.
Joohi Jimenez-shahed, MD principal investigator
Mount Sinai, Clinical Neurosciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral Exablate MRgFUS Pallidothalamic Tractotomy, Staged Bilateral Exablate Pallidothalamic Tractotomy and Best Medical Treatment (BMT) in people with Parkinson Disease, run by InSightec at 1 site in South Korea.
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 10 inclusion and 29 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 20 Oct 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 South Korea. 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 Elisa Cerutti, PhD (+39 3459182413, elisac@insightec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDS-UPRDS Part III ULE score in the OFF-medication (unilateral treatment) (time frame: 3 Months). The study lists 2 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 20 Oct 2026.