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NCT03253991
A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Essential Tremor
NA trial testing MRgFUS treatment in Essential Tremor in 154 participants. Terminated before completion.
2 February 2023
Quick facts
| Lead sponsor | InSightec |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 154 |
| Start date | 17 November 2014 |
| Primary completion | 2 February 2023 |
| Estimated completion | 2 February 2023 |
| Sites | 11 locations across China, Taiwan, Japan |
Drugs / interventions tested
- MRgFUS treatment
Conditions studied
- Essential Tremor — all drugs for Essential Tremor →
Sponsor
InSightec — full company profile →
Who can join
Adults 22 to 99, any sex, with Essential Tremor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects The objective of this prospective, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor inpatients with essential tremor (ET). The Indications for Use claim for this system is as follows: Treatment of medication-refractory tremor in patients with essential tremor.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Magnetic Resonance-Guided Focused Ultrasound : Current Status and Future Perspectives in Thermal Ablation and Blood-Brain Barrier Opening.
Lee EJ, Fomenko A, Lozano AM. · · 2019 · cited 45× · PMID 30630292 · DOI 10.3340/jkns.2018.0180 -
Focused ultrasound thalamotomy for tremor treatment impacts the cerebello-thalamo-cortical network.
Dahmani L, Bai Y, Li M, Ren J, et al · · 2023 · cited 16× · PMID 37322044 · DOI 10.1038/s41531-023-00543-8 -
Targeted manipulation of pain neural networks: The potential of focused ultrasound for treatment of chronic pain.
Todd N, McDannold N, Borsook D. · · 2020 · cited 13× · PMID 32534900 · DOI 10.1016/j.neubiorev.2020.06.007 -
Magnetic Resonance-Guided Focused Ultrasound Thalamotomy Rebalances Atypical Functional Hierarchy in Patients with Essential Tremor.
Lin J, Kang X, Lu H, Zhang D, et al · · 2023 · cited 4× · PMID 37843768 · DOI 10.1007/s13311-023-01442-9 -
Profiling functional networks identify activation of corticostriatal connectivity in ET patients after MRgFUS thalamotomy.
Lin J, Kang X, Zhou J, Zhang D, et al · · 2024 · cited 2× · PMID 38640802 · DOI 10.1016/j.nicl.2024.103605 -
Magnetic resonance-guided focused ultrasound for essential tremor: a prospective, single center, single-arm study.
Zong R, Li X, Yin C, He J, et al · · 2024 · cited 2× · PMID 38227538 · DOI 10.4103/1673-5374.391192 -
A deep learning approach to remotely assessing essential tremor with handwritten images.
Peng Y, Han S, Wu D, Ma C, et al · · 2025 · cited 1× · PMID 40155628 · DOI 10.1038/s41598-025-94729-0
Verify or expand the search:
- PubMed search for NCT03253991
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MRgFUS treatment
Trials testing the same drug.
- NCT05624385 — MRgFUS Thalamotomy for Therapy-Resistant Tremor-related Disease With Low SDR Value · NA · unknown
- NCT03467165 — MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain · NA · completed
Other recruiting trials for Essential Tremor
Currently open trials in the same condition.
- NCT07417280 — LIFUS For Neurological Disorders · NA · recruiting
- NCT07172295 — Modulate Tremor Severity With Low-intensity Focused Ultrasound Stimulation Targeting the Deep Nucleus of Patients With R · NA · recruiting
- NCT07016425 — Temporal Interference for Essential Tremor · NA · recruiting
- NCT07049003 — Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor · Phase 1 · recruiting
- NCT06428526 — Impact of Sensory Electrical Stimulation on Sensation and Tremor · NA · active not recruiting
Other InSightec trials
Trials by the same sponsor.
- NCT04667715 — Safety and Effectiveness of Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma · NA · withdrawn
- NCT05539196 — A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advance · recruiting
- NCT05089786 — Echo-Focusing in Patients With Treatment-Resistant Neurologic and Psychiatric Indications (EF001) · NA · unknown
- NCT05565443 — MR-guided Focused Ultrasound Plus GCase · NA · recruiting
- NCT05317858 — Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03253991 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by InSightec
- Last refreshed: 20 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03253991.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing