One‑session bilateral radiofrequency thalamotomy to reduce medication‑resistant essential tremor

Simultaneous Bilateral Radiofrequency Thalamotomy for Medication-Refractory Essential Tremor

This trial will try a single‑session procedure that creates small lesions on both sides of the thalamus with radiofrequency energy to reduce disabling hand tremor in adults whose essential tremor has not improved with medicines.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 20 Years to 70 Years
• Sex: All
• Sponsor: Tokyo Women's Medical University (other)
• Locations: 1 site (Shinjuku-Ku, Tokyo)
• Trial ID: NCT07066358 on ClinicalTrials.gov

What this trial studies

This is a prospective, single‑arm feasibility and safety trial enrolling five adults with medication‑refractory essential tremor. Participants will undergo stereotactic, simultaneous bilateral radiofrequency lesioning of the ventral intermediate nucleus (Vim) of the thalamus in a single operative session with MRI used for planning and intraoperative guidance. Preoperative clinical assessments and MRI are performed, and standardized tremor rating scales and follow‑up visits will monitor outcomes and adverse effects. The protocol focuses on short‑term safety (including speech, swallowing, and gait) and early efficacy for bilateral tremor suppression.

Who should consider this trial

Good fit: Adults aged 20 to 70 with neurologist‑diagnosed essential tremor that has not responded to standard medications, who can undergo MRI and meet cognitive (MMSE ≥27) and surgical fitness criteria, are ideal candidates.

Not a fit: People with bleeding tendencies, MRI contraindications or significant intracranial pathology, pregnant or breastfeeding individuals, those with cognitive impairment, or those whose tremor is controlled by medication are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, the procedure could reduce tremor in both hands with a single operation, improving daily activities such as writing, eating, and dressing.

How similar studies have performed: Staged bilateral thalamotomies and MR‑guided focused ultrasound approaches have shown promising results, but simultaneous bilateral radiofrequency thalamotomy has been rarely studied and remains largely untested.

Eligibility criteria

Inclusion Criteria:

* Adults aged 20 to 70 years.
* Diagnosis of essential tremor by a neurologist or neurosurgeon specializing in movement disorders.
* Refractory to standard pharmacological therapy (e.g., propranolol, primidone, benzodiazepines, or alprenolol).
* Mini-Mental State Examination (MMSE) score ≥ 27.
* Able to undergo MRI.
* Provided written informed consent for participation in the study.

Exclusion Criteria:

* History or evidence of bleeding tendency.
* MRI contraindications (e.g., metallic implants, severe claustrophobia).
* Presence of intracranial pathology on preoperative MRI that would interfere with surgery.
* Pregnant or breastfeeding individuals.
* Any other condition that the principal investigator deems inappropriate for study participation.

Where this trial is running

Shinjuku-Ku, Tokyo

• Tokyo Women's Medical University, Department of Neurosurgery — Shinjuku-Ku, Tokyo, Japan (RECRUITING)

Study contacts

• Principal investigator: Shiro HORISAWA, MD — Tokyo Women's Medical University
• Study coordinator: SHIRO Horisawa, MD

Conditions: Essential Tremor, thalamotomy, intraoperative MRI