A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects

A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects - Treatment of essential tremor with focused ultrasound

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010714

Enrollment

Registered

2013-06-01

Start date

2013-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential tremor

Interventions

Focused ultrasound treatment Sham treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A diagnosis of essential tremor by a specialist Tremor refractory to adequate trials of at least two medications Significant disability due to essential tremor despite medical treatment

Exclusion criteria

Exclusion criteria: Unstable cardiac status Severe hypertension (diastolic BP > 100 on medication) Standard contraindications for MR imaging Severely impaired renal function History of abnormal bleeding and/or coagulopathy History of intracranial hemorrhage Infectioous or immunocompromise state Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment Presence of any other neurodegenerative disease or Parkinsonism Presence of significant cognitive impairment as determined with a score &#8804; 24 on the Mini Mental Status Examination

Design outcomes

Primary

Measure	Time frame
Tremor improvement and evaluation of advers effect 12 months after treatment	—

Countries

Japan,Asia(except Japan),North America,Europe

Contacts

Public ContactTakaomi Taira

Tokyo Womnes's Medical University Department of Neurosurgery

ttaira@nij.twmu.ac.jp03-3353-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026