Focused ultrasound is being studied as a way to alter Parkinson’s disease motor circuits without opening the skull. The best-established Parkinson’s studies use MRI-guided thermal lesioning—creating a precisely placed, permanent lesion in one brain target or pathway. A separate, much earlier approach uses low-intensity ultrasound to modulate activity without intentionally destroying tissue. In the United States, a narrow FDA indication covers unilateral pallidothalamic tractotomy for some adults with advanced idiopathic Parkinson’s disease and medication-refractory motor complications. The procedure can improve selected motor symptoms, but it is not a cure, is not appropriate for everyone, and can cause persistent speech, gait, balance, weakness, or other problems.
What “focused ultrasound” means in Parkinson’s research
Focused ultrasound (FUS) concentrates sound-wave energy at a chosen point deep inside the brain. During an MRI-guided procedure, MRI is used to locate the target, plan the treatment, and monitor the tissue while ultrasound energy is delivered. In the lesioning procedures studied for Parkinson’s disease, the energy raises the temperature at the target until it creates a small thermal lesion. This can interrupt abnormal circuit activity without a craniotomy or an implanted stimulation lead.
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The phrase “focused ultrasound” covers two fundamentally different strategies. They should not be presented as interchangeable treatments.
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MRI-guided thermal lesioning
Thermal lesioning is the approach with the clearest clinical evidence in the supplied Parkinson’s studies. Depending on the target, investigators have studied:
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- Subthalamotomy: lesioning part of the subthalamic nucleus.
- Pallidotomy: lesioning a section of the globus pallidus.
- Pallidothalamic tractotomy: lesioning a motor pathway connecting pallidal output toward the thalamus.
These operations are usually unilateral, meaning one side of the brain is treated. A staged bilateral approach treats the opposite side later in carefully selected patients. Because a thermal lesion is intended to be permanent, an unwanted effect cannot simply be switched off in the way an implanted stimulation device can be adjusted.
Low-intensity focused-ultrasound neuromodulation
Low-intensity focused ultrasound is a separate investigational concept. Rather than heating tissue to destroy it, researchers are testing whether lower-intensity acoustic energy can temporarily change activity in a circuit. ClinicalTrials.gov lists an early-feasibility Parkinson’s study, NCT06763692. The existence of that study shows that the approach is being investigated; it does not establish clinical effectiveness or make it an approved treatment.
Is focused ultrasound FDA-approved for Parkinson’s disease?
The U.S. FDA’s Exablate Neuro PMA supplement S037 has a decision date of July 3, 2025. Its indication is specific and should not be generalized to every person with Parkinson’s disease or to every focused-ultrasound target.
| FDA-labeled element | What the record specifies |
|---|---|
| Procedure | Unilateral pallidothalamic tractotomy, performed with focused ultrasound. |
| Condition | Advanced idiopathic Parkinson’s disease. |
| Problem to be treated | Medication-refractory moderate-to-severe motor complications, as an adjunct to Parkinson’s medication. |
| Age | At least 30 years old. |
| Target requirement | The intended target must be identifiable and accessible for thermal ablation. |
| Possible second side | The untreated contralateral side may be treated in a staged unilateral procedure at least six months after the first procedure when contralateral medication-refractory motor complications meet the criteria. |
This is a U.S. device indication. It does not establish approval, reimbursement, or availability in another country. It also does not mean that a person who meets the headline diagnosis automatically qualifies: a movement-disorders team must determine whether the anatomy, symptoms, medication response, imaging, and overall health fit the labeled use and the center’s protocol.
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What the clinical studies have found
Unilateral subthalamotomy: randomized sham-controlled evidence
A prospective, randomized, double-blind, sham-controlled NEJM trial enrolled 40 people with markedly asymmetric Parkinson’s disease. Twenty-seven were assigned to active unilateral subthalamotomy and 13 to a sham procedure. Four months later, the motor score on the more-affected side improved more in the active-treatment group than in the sham group. The reported between-group difference was 8.1 points, with a 95% confidence interval of 6.0 to 10.3 and P<0.001.
That result is important because the design included a sham control and blinded assessment. It applies to the selected participants, the subthalamic target, the particular outcome measure, and the four-month comparison—not to every person with Parkinson’s disease and not to disease progression itself.
The same trial documented clinically meaningful harms. Reported adverse events included dyskinesia, weakness on the treated side, speech disturbance, facial weakness, and gait disturbance. Some events remained at four months, and some deficits were still reported at 12 months. The study authors’ conclusion was that focused-ultrasound subthalamotomy improved motor features in selected patients with asymmetric signs while also producing speech and gait disturbances, weakness, and dyskinesia in some participants.
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Scan for outdated or missing drivers - takes under a minuteDriver Scan →Repair Windows errors before they cause bigger problemsFix Now →Staged bilateral pallidothalamic tractotomy: prospective single-arm evidence
A prospective, multicentre, single-arm study indexed in 2026 evaluated staged treatment. Fifty-four participants underwent unilateral treatment; 40 proceeded to a second procedure on the opposite side at least six months later. Among those who received bilateral treatment, the reported median bilateral upper- and lower-extremity motor score fell from 33.0 at baseline to 21.0 three months after the second procedure. The authors reported a median within-person change of 10.5 points, described as a 32% improvement.
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This study did not randomly assign participants to sham treatment, medication, deep-brain stimulation, or another operation. Its motor result therefore cannot be interpreted as proof that bilateral tractotomy is superior to those alternatives.
Treatment-related adverse events occurred in 21 of 54 participants after unilateral treatment and in 22 of 40 after bilateral treatment. At 12 months after bilateral treatment, 10 of 40 participants had persistent moderate or severe adverse events, mainly involving speech, gait, and balance. One participant developed severe persistent anarthria—the inability to produce understandable speech. The investigators interpreted the findings as motor gains accompanied by a higher burden of persistent moderate or severe adverse events, reinforcing the need for conservative selection and explicit counselling.
Other registered studies
ClinicalTrials.gov lists NCT03319485 as a pivotal prospective, two-arm, sham-controlled, randomized multicentre study of unilateral Exablate pallidotomy for dyskinesia or motor fluctuations in people with medication-refractory advanced idiopathic Parkinson’s disease. A registry entry establishes the study’s design and purpose; it is not, by itself, evidence of a positive result.
The separate NCT06763692 early-feasibility study is testing low-intensity focused-ultrasound neuromodulation. Its results should not be combined with thermal-lesion studies because the mechanism, permanence, target strategy, and risk profile are different.
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Which symptoms might improve?
The studies are aimed at motor complications rather than every feature of Parkinson’s disease. Depending on the target and the participant’s symptom pattern, investigators have measured tremor, rigidity, bradykinesia, dyskinesia, motor fluctuations, and limb motor scores. The strongest randomized evidence cited here concerns the more-affected-side motor score after unilateral subthalamotomy. The staged bilateral study reports a broader bilateral motor-score change after two procedures.
These findings do not establish reliable treatment for nonmotor symptoms such as depression, sleep problems, constipation, pain, cognitive changes, or autonomic dysfunction. They also do not show that focused ultrasound halts or reverses the underlying neurodegenerative process. Symptom improvement and disease modification are different outcomes.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Risks and trade-offs to discuss
The central trade-off is permanence. Thermal lesioning can remove the need for an implanted electrode, but a lesion cannot be reprogrammed if the benefit is incomplete or an adverse effect appears. The risk depends on the target, side treated, lesion location, patient anatomy, and the expertise of the treating center.
- Speech: speech disturbance was reported after unilateral subthalamotomy; persistent speech impairment was a prominent issue in the staged bilateral study, including one case of severe persistent anarthria.
- Gait and balance: gait disturbance occurred in the randomized trial, and gait or balance problems accounted for many persistent moderate or severe events after bilateral treatment.
- Weakness and facial weakness: weakness on the treated side and facial weakness were reported in the subthalamotomy trial.
- Dyskinesia: dyskinesia was reported as an adverse event even though motor complications are among the problems the procedures aim to manage.
- Two-sided treatment risk: treating both sides can broaden motor benefit but may increase the chance of persistent speech, gait, and balance deficits. The staged study’s 12-month findings illustrate why the second side is delayed and considered separately.
A specialist should explain which effects are expected to be temporary, which could be permanent, how often they occurred in the center’s own experience, and what rehabilitation or emergency plan would apply if speech, strength, walking, or swallowing worsened.
How a specialist decides whether someone is a candidate
FDA labeling is only one filter. A movement-disorders neurologist and an experienced focused-ultrasound team generally need to connect the symptoms to the proposed target and verify that the procedure’s risks are acceptable.
- Confirm the diagnosis and stage. The U.S. indication concerns advanced idiopathic Parkinson’s disease, not an undifferentiated tremor syndrome or every parkinsonian disorder.
- Document medication-refractory motor complications. The team reviews which symptoms remain disabling despite medication, how consistently they respond, and whether fluctuations or dyskinesia are the main problem.
- Map the symptom pattern. Marked asymmetry may matter for a unilateral operation. The side of the body affected, speech and gait status, balance reserve, and cognitive or psychiatric symptoms all influence risk.
- Review MRI and targeting feasibility. The target must be identifiable and accessible for thermal ablation. Skull characteristics, prior procedures, and other imaging findings can affect whether adequate ultrasound energy can reach the target.
- Compare alternatives. The consultation should cover continued or adjusted medication, deep-brain stimulation, lesioning options, rehabilitation, and no procedure. The evidence summarized here does not provide a head-to-head ranking against medication regimens or deep-brain stimulation.
- Plan one side at a time when appropriate. If the first procedure works and the opposite side later meets criteria, the FDA record permits staged treatment at least six months afterward. That is a new risk-benefit decision, not an automatic second session.
How to compare the approaches without overstating the evidence
| Approach | What is changed | Evidence described here | Main interpretation |
|---|---|---|---|
| Unilateral subthalamotomy | Permanent thermal lesion in one subthalamic nucleus | Randomized, sham-controlled, double-blind trial; 40 participants | Improved the more-affected-side motor score in selected people, with reported speech, gait, weakness, facial weakness, and dyskinesia risks. |
| Unilateral pallidotomy | Permanent lesion in one pallidal target | Pivotal randomized multicentre study registered as NCT03319485 | The registry describes the trial design; its listing alone does not prove benefit. |
| Unilateral pallidothalamic tractotomy | Permanent lesion in one pallidothalamic pathway | FDA-labeled U.S. indication for a defined group; prospective studies include staged treatment | Approved use is narrow and adjunctive to medication, with anatomy, age, symptom, and staging conditions. |
| Staged bilateral tractotomy | A second permanent lesion at least six months after the first | Prospective, multicentre, single-arm study; 54 unilateral and 40 bilateral participants | Reported bilateral motor improvement, but persistent speech, gait, and balance harms require careful selection. |
| Low-intensity neuromodulation | Intended activity modulation without thermal ablation | Early-feasibility study NCT06763692 | Investigational; do not infer effectiveness from study registration. |
These studies use different targets, designs, symptom profiles, and follow-up periods. A randomized sham-controlled result cannot be directly merged with a single-arm staged series, and none of the cited evidence establishes superiority over deep-brain stimulation or medication.
Questions to take to a treatment consultation
- Which target and procedure are you proposing, and why does it match my dominant symptoms?
- Is the recommendation within the FDA-labeled use in the United States, or is it part of a clinical study?
- What are your center’s rates of persistent speech, gait, balance, weakness, swallowing, and dyskinesia problems?
- How will you test my symptoms before and after treatment, and for how long?
- If one side is treated, what would make a second side reasonable or unsafe?
- How would this option compare with medication adjustment, deep-brain stimulation, rehabilitation, or observation for my specific situation?
- What is the plan if the lesion does not provide enough benefit or causes a lasting deficit?
What patients should conclude
Focused ultrasound is a real but narrowly defined treatment option and an active research field. MRI-guided thermal lesioning has shown motor improvement in selected Parkinson’s populations, including a sham-controlled unilateral subthalamotomy trial and a later single-arm study of staged bilateral pallidothalamic tractotomy. Those gains come with meaningful risks, particularly for speech, gait, balance, weakness, and dyskinesia. Low-intensity neuromodulation is an earlier, separate line of investigation. Eligibility, target choice, and whether a permanent lesion is acceptable can only be decided through an individualized movement-disorders assessment.
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