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Focused ultrasound is being studied as an MRI-guided way to alter movement-related brain circuits in carefully selected people with Parkinson’s disease. The best-established Parkinson’s studies use high-intensity ultrasound to create a small, permanent thermal lesion without opening the skull. A separate, much earlier line of research uses low-intensity ultrasound to modulate brain activity without making a lesion. Neither approach is a cure, and the U.S. authorization applies only to a narrowly defined treatment and patient population.
What focused ultrasound does in Parkinson’s disease
MRI-guided focused ultrasound (MRgFUS) concentrates many ultrasound beams on a target deep inside the brain. The MRI provides anatomical targeting and temperature monitoring while the ultrasound energy is delivered. In the lesioning procedures studied for Parkinson’s disease, enough energy is applied to heat a selected structure or pathway and create a controlled lesion. Because the energy passes through the skull, the procedure does not require a craniotomy or an implanted stimulation electrode.
The targets studied include the subthalamic nucleus, the globus pallidus and the pallidothalamic tract. These structures participate in the circuits that regulate movement. The goal is symptom control—such as reducing dyskinesia, tremor or medication-related motor fluctuations—not removal of the underlying neurodegenerative process.
Thermal lesioning and neuromodulation are different
The phrase focused ultrasound covers more than one technology. High-intensity MRgFUS lesioning intentionally destroys a small amount of tissue, so the effect is intended to be lasting. Studies have called the operations subthalamotomy, pallidotomy or pallidothalamic tractotomy, depending on the target.
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Low-intensity focused-ultrasound neuromodulation uses substantially lower energy to influence neural activity without creating a permanent thermal lesion. ClinicalTrials.gov lists NCT06763692 as an early-feasibility study of this approach in Parkinson’s disease. The existence of that study shows that the technique is being investigated; it does not establish that it improves symptoms or is available as treatment.
Is focused ultrasound FDA-approved for Parkinson’s disease?
In the United States, the FDA’s Exablate Neuro PMA supplement S037 records a decision date of July 3, 2025. The labeled use is unilateral pallidothalamic tractotomy for advanced idiopathic Parkinson’s disease with medication-refractory moderate-to-severe motor complications, used as an adjunct to Parkinson’s medication. This is a specific device indication, not a general approval for every Parkinson’s symptom or every stage of the disease.
The FDA labeling also permits staged treatment of the untreated opposite side, but only at least six months after the first procedure and only when the contralateral side has medication-refractory motor complications. Patients must be at least 30 years old, and the intended target must be identifiable and accessible for thermal ablation. These are U.S. labeling conditions; an FDA indication does not establish approval, reimbursement or availability in another country.
What the approval does not mean
- It does not mean focused ultrasound halts, reverses or cures Parkinson’s disease.
- It does not mean every person with tremor, dyskinesia or gait problems is eligible.
- It does not establish superiority over medication, deep-brain stimulation or other procedures across all patient groups.
- It does not turn an investigational low-intensity neuromodulation protocol into an approved therapy.
A movement-disorders team must determine whether a person meets the labeled criteria, whether the target can be visualized and reached safely, and whether expected benefits justify the possibility of an irreversible lesion.
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How a lesioning procedure is studied
Although protocols differ by trial and target, the treatment concept follows a consistent sequence:
- Clinical selection: Investigators document the Parkinson’s diagnosis, medication response, motor complications and distribution of symptoms. Trials often select people with advanced disease or strongly asymmetric signs rather than an unselected Parkinson’s population.
- Imaging and targeting: MRI is used to map the intended structure or pathway and confirm that the target is accessible through the skull.
- Low-energy verification: The team can deliver lower-energy sonications while monitoring the participant and checking whether the intended symptom changes occur without producing an unsafe temperature rise.
- Thermal ablation: Once the target is confirmed, higher-energy sonications raise tissue temperature enough to create the planned lesion. MRI thermometry helps monitor the heating.
- Follow-up: Motor scores, medication use, speech, gait, balance and neurological adverse events are assessed over months. Long-term follow-up is important because a lesion cannot simply be removed if a delayed deficit appears.
Unlike implanted stimulation, lesioning does not leave a generator or lead that can be reprogrammed. That irreversibility is part of the reason trials emphasize careful selection and adverse-event monitoring.
What the clinical evidence shows
The available studies answer different questions and should not be combined into one effectiveness number. A randomized sham-controlled trial provides stronger evidence of a treatment effect than a single-arm study, while a newer bilateral study supplies information about staged treatment but has no sham comparison.
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One free scan finds every outdated or missing driver and matches the right update for your exact hardware.Free scan · exact hardware match| Study or approach | Design and participants | Reported finding | Important qualification |
|---|---|---|---|
| Unilateral subthalamotomy | Prospective, randomized, sham-controlled, double-blind NEJM trial; 40 people enrolled, with 27 assigned active treatment and 13 sham | At four months, the between-group difference in the more-affected-side motor score was 8.1 points (95% confidence interval, 6.0 to 10.3; P<0.001) | Participants had markedly asymmetric Parkinson’s disease; the result applies to that selected population, target and follow-up |
| Staged bilateral pallidothalamic tractotomy | Prospective multicentre single-arm study reported in 2026; 54 received unilateral treatment and 40 proceeded to a second procedure at least six months later | After bilateral treatment, the median bilateral upper- and lower-extremity motor score fell from 33.0 at baseline to 21.0 at three months; the reported median within-person change was 10.5 points, or 32% | There was no sham or active comparator, so the change cannot be interpreted as proof of superiority or as a controlled treatment effect |
| Unilateral pallidotomy trial | ClinicalTrials.gov NCT03319485: pivotal prospective, two-arm, sham-controlled randomized multicentre study | The registry establishes the trial design and population being studied | A registry entry alone does not prove a positive clinical outcome |
| Low-intensity neuromodulation | ClinicalTrials.gov NCT06763692: early-feasibility investigation | Represents a distinct non-lesioning research approach | Early feasibility does not establish effectiveness, durability or routine clinical availability |
Unilateral subthalamotomy: the controlled result
The NEJM study is notable because participants were randomly assigned to active treatment or a sham procedure and evaluators were blinded. The active group’s more-affected-side motor score improved more than the sham group’s at four months, with an 8.1-point adjusted difference and a confidence interval from 6.0 to 10.3 points. That finding supports a motor benefit in selected people with markedly asymmetric disease.
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The same trial also recorded clinically meaningful harms. Adverse events included dyskinesia, weakness on the treated side, speech disturbance, facial weakness and gait disturbance. Some events remained at the four-month assessment, and some deficits were still reported at 12 months. The motor result therefore cannot be presented without the accompanying risk of persistent neurological impairment.
Staged bilateral pallidothalamic tractotomy: newer but uncontrolled evidence
The 2026 prospective multicentre study provides a different perspective. Of 54 participants who underwent unilateral treatment, 40 chose or were eligible for a second procedure at least six months later. Three months after bilateral treatment, the reported median bilateral upper- and lower-extremity motor score improved by 32%, from 33.0 to 21.0, with a median within-person change of 10.5 points.
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 or balance. One participant developed severe persistent anarthria, meaning an inability to produce understandable speech. Because this was a single-arm study, the reported motor improvement does not separate the procedure’s effect from placebo effects, follow-up effects, medication changes or selection of participants who proceeded to bilateral treatment.
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Focused-ultrasound lesioning is being studied primarily for motor complications that remain disabling despite medication. Depending on the target and trial, this can include tremor, dyskinesia, motor fluctuations and other movement-related impairments. The strongest controlled evidence in the cited material concerns improvement in the treated side of people with markedly asymmetric motor signs after unilateral subthalamotomy.
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Benefits are measured with standardized motor examinations and patient-reported outcomes rather than by claiming that Parkinson’s has disappeared. Improvement can be incomplete, limited to one side or offset by a new deficit. A procedure aimed at one circuit may not improve every symptom, particularly symptoms driven by different brain systems or by non-motor aspects of Parkinson’s disease.
Risks, limitations and irreversible trade-offs
The principal trade-off is that thermal lesioning is intended to be permanent. A successful lesion may reduce a troublesome motor circuit activity, but an inaccurately placed or overly large lesion can damage nearby pathways. Across the cited studies, the adverse effects that deserve explicit discussion include:
- Speech disturbance, including severe persistent anarthria in one participant in the bilateral study.
- Gait and balance problems, which can increase fall risk and may persist.
- Weakness on the treated side or facial weakness.
- Dyskinesia or other abnormal movements.
- Persistent moderate or severe neurological adverse events after bilateral treatment.
Bilateral treatment deserves particular caution because affecting both sides of movement-related circuits can increase speech, gait and balance complications. The 2026 investigators interpreted the combination of motor gains and persistent adverse events as a reason for careful selection and counselling, not as evidence that bilateral treatment is appropriate for everyone.
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Eligibility is determined by a specialist center rather than by a single symptom. In the U.S. labeling summarized above, the relevant profile includes advanced idiopathic Parkinson’s disease, medication-refractory moderate-to-severe motor complications, age 30 or older, and a target that can be identified and safely accessed for thermal ablation.
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A specialist evaluation commonly needs to establish:
- Whether the diagnosis is idiopathic Parkinson’s disease rather than an atypical parkinsonian disorder.
- Which symptoms remain disabling despite optimized medication and whether those symptoms match the proposed target.
- Whether symptoms are sufficiently one-sided for unilateral treatment and, if bilateral treatment is contemplated, whether the staged timing and contralateral criteria are met.
- Whether MRI and other screening can identify an adequate acoustic path and exclude anatomical or medical factors that make the procedure unsafe.
- How speech, gait, balance, cognition and existing weakness could affect the risk-benefit decision.
Patients should ask which target is proposed, what evidence supports that target for their symptom pattern, how often the center performs the procedure, what deficits have occurred in its own follow-up, and what alternatives remain if the result is incomplete or a complication develops.
How focused ultrasound compares with other Parkinson’s treatments
The cited evidence does not provide a head-to-head comparison of focused ultrasound with deep-brain stimulation or medication regimens. It therefore cannot support a general ranking of those options. The meaningful comparison is individual: whether a person values an incisionless, non-implanted procedure despite its irreversible lesion and neurological risks, or whether another treatment offers a more suitable balance of adjustability, symptom coverage and risk.
When discussing options with a clinician, compare them on the following axes:
- Target: subthalamotomy, pallidotomy or pallidothalamic tractotomy, versus a target used by another therapy.
- Laterality: one-sided treatment or a second procedure staged at least six months later under the labeled conditions.
- Evidence: randomized sham-controlled data versus single-arm observational results.
- Symptom pattern: tremor, dyskinesia, fluctuations, asymmetry and medication response represented in the relevant study.
- Reversibility and adverse effects: especially speech, gait, balance, weakness and dyskinesia.
What remains unknown
Current evidence does not establish that focused ultrasound slows Parkinson’s progression, restores lost neurons or reverses the disease. It also does not show that every patient with Parkinson’s is eligible, that bilateral lesioning is broadly safe, or that any focused-ultrasound approach is superior to medication or deep-brain stimulation for all patient groups.
The most defensible description is narrower: MRI-guided thermal lesioning can improve selected motor outcomes in selected patients, with measurable risks that may persist. Low-intensity neuromodulation is an earlier investigational path whose clinical value remains to be determined.
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