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NeuroHarmonics launches first patient trial of non-invasive deep-brain ultrasound for essential tremor

NeuroHarmonics launches first patient trial of non-invasive deep-brain ultrasound for essential tremor

London-based neurotechnology company NeuroHarmonics is set to begin recruiting patients for the first clinical evaluation of its non-invasive deep-brain ultrasound platform in essential tremor, following regulatory clearance from the Medicines and Healthcare products Regulatory Agency (MHRA) and a favourable Research Ethics Committee opinion. The study will be conducted at the National Hospital for Neurology and Neurosurgery (NHNN) within University College London Hospitals NHS Foundation Trust (UCLH), supported by GBP 1.2 million (USD 1.6 million) in Innovate UK funding under the Biomedical Catalyst programme.

The sham-controlled study will enrol adults aged 18–80 whose essential tremor is inadequately controlled by, or who cannot tolerate, first-line medication. Primary endpoints are safety and tolerability, alongside preliminary evidence of target engagement — defined as a measurable change in tremor, recorded by movement sensors, compared with sham stimulation. Any tremor effects are expected to be temporary; the study is not designed to establish clinical efficacy. A follow-on study involving repeated stimulation sessions is planned under the same funding programme.

The NeuroHarmonics platform focuses low-intensity ultrasound through the intact skull onto the ventral intermediate nucleus (VIM) of the thalamus — the same structure targeted by deep brain stimulation (DBS) and MRI-guided focused ultrasound (MRgFUS) — guided by each participant's MRI scan and computational skull models. Sessions require no surgery, anaesthesia, implant, or head shaving, and are designed for an outpatient setting. Unlike MRgFUS, the stimulation is non-ablative and repeatable. The UCL spinout's approach builds on foundational research published in Nature Communications demonstrating millimetre-precision stimulation of a deep thalamic structure in humans.

Essential tremor affects approximately 1% of the general population and around 5% of people over 65 — more than 600,000 individuals in the UK alone. First-line pharmacological agents, including propranolol and primidone, adequately control symptoms in roughly half of patients. For those with refractory tremor, DBS and MRgFUS both target the VIM effectively, but access is severely constrained: approximately 200 patients per year in the UK receive either procedure.

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The VIM sits within a cerebello-thalamo-cortical circuit implicated in tremor generation. Published neurophysiological work has identified tremor-related local field potentials and single-unit discharges within the VIM coherent with peripheral tremor, establishing it as a validated neuromodulation target. Low-intensity transcranial ultrasound stimulation (TUS) has been studied in more than 700 participants in published human research, though prior work noted that demonstrating overt motor behavioural changes in humans remained an open challenge. A preliminary case series targeting the VIM with low-intensity focused ultrasound across eight sessions reported initial feasibility, but the field lacks a device engineered for routine outpatient delivery.

On the pharmacological side, Cambridge, Massachusetts-based Praxis Precision Medicines (Nasdaq: PRAX) has reported positive Phase III data for ulixacaltamide HCl, a T-type calcium channel blocker targeting aberrant thalamic oscillations, with an FDA review underway. That programme addresses the same circuit through systemic pharmacology rather than focal neuromodulation, and its effects would be continuous rather than session-based. Israel-based Insightec's Exablate Neuro device delivers MRgFUS ablation and holds FDA approval for essential tremor, but creates a permanent unilateral lesion. NeuroHarmonics occupies a distinct position: non-ablative, repeatable, and designed for an outpatient setting rather than specialist surgical centres.

Chief Investigator Dr Anna Latorre of the NHNN and UCL Queen Square Institute of Neurology leads the study, with the Leonard Wolfson Experimental Neurology Centre (LWENC) serving as the clinical research site.


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