NCT03964272 is a NA clinical trial of Exablate Bilateral Subthalamotomy in Parkinson Disease, sponsored by InSightec.

Who is sponsoring NCT03964272?

NCT03964272 is sponsored by InSightec.

What drugs are being tested in NCT03964272?

Interventions in NCT03964272: Exablate Bilateral Subthalamotomy.

What condition does NCT03964272 study?

NCT03964272 studies Parkinson Disease, Neurologic Manifestations.

Is NCT03964272 still recruiting?

NCT03964272 is currently completed. Last updated 20 March 2026.

Last reviewed 2026-03-20 · How we verify

NCT03964272

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD

Completed NA Last updated 20 March 2026

What this trial tests

NA trial testing Exablate Bilateral Subthalamotomy in Parkinson Disease in 6 participants. Completed in 7 November 2023.

Timeline

18 June 2019

Primary endpoint
7 November 2023

7 November 2023

Quick facts

Lead sponsor	InSightec
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	6
Start date	18 June 2019
Primary completion	7 November 2023
Estimated completion	7 November 2023
Sites	1 location across Spain

Drugs / interventions tested

Exablate Bilateral Subthalamotomy

Conditions studied

Parkinson Disease — all drugs for Parkinson Disease →
Neurologic Manifestations — all drugs for Neurologic Manifestations →

Sponsor

InSightec — full company profile →

Who can join

Adults 30 to 75, any sex, with Parkinson Disease or Neurologic Manifestations. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to test the safety and preliminary efficacy of staged bilateral subthalamotomy performed using the ExAblate Transcranial System for the treatment of Parkinson's disease (PD) motor features

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Prospective Long-term Follow-up of Focused Ultrasound Unilateral Subthalamotomy for Parkinson Disease.
Martínez-Fernández R, Natera-Villalba E, Máñez Miró JU, Rodriguez-Rojas R, et al · · 2023 · cited 31× · PMID 36631272 · DOI 10.1212/wnl.0000000000206771
Parkinson's disease therapy: what lies ahead?
Wolff A, Schumacher NU, Pürner D, Machetanz G, et al · · 2023 · cited 19× · PMID 37147404 · DOI 10.1007/s00702-023-02641-6
Staged Bilateral MRI-Guided Focused Ultrasound Subthalamotomy for Parkinson Disease.
Martínez-Fernández R, Natera-Villalba E, Rodríguez-Rojas R, Del Álamo M, et al · · 2024 · cited 16× · PMID 38739377 · DOI 10.1001/jamaneurol.2024.1220
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
Bilateral Focused Ultrasound Pallidotomy for Parkinson-Related Facial Dyskinesia-A Case Report.
Stieglitz LH, Mahendran S, Oertel MF, Baumann CR. · · 2022 · cited 12× · PMID 35844284 · DOI 10.1002/mdc3.13462

Verify or expand the search:

Other recruiting trials for Parkinson Disease

Currently open trials in the same condition.

NCT07399496 — Accelerated TMS for Apathy in PD · NA · recruiting
NCT07371338 — Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients · Phase 1 · recruiting
NCT07442370 — The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients · NA · recruiting
NCT06848205 — Percept Transitions in FOG and PD · NA · recruiting
NCT07432958 — A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (P · Phase 2 · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03964272 (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 March 2026

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/NCT03964272.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing