Simultaneous Bilateral Radiofrequency Thalamotomy for Medication-Refractory Essential Tremor

Sponsor
Tokyo Women's Medical University
Study ID
NCT07066358
Status
Recruiting
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Conditions

  • Essential Tremor

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Simultaneous Bilateral RF Thalamotomy — PROCEDURE
    This intervention involves simultaneous bilateral radiofrequency (RF) lesioning of the ventral intermediate nucleus (Vim) of the thalamus using a stereotactic frame under local anesthesia. The procedure begins with RF ablation on the side contralateral to the dominant hand. Intraoperative MRI is then performed to confirm the absence of hemorrhagic complications. If no bleeding or other adverse events are detected, the procedure proceeds to the contralateral Vim. If hemorrhage is identified, the surgery is terminated after unilateral treatment. This technique allows for immediate bilateral tremor reduction in patients with medication-refractory essential tremor, while prioritizing patient safety through intraoperative imaging-based decision-making.

Study Details

This study aims to evaluate the safety and effectiveness of simultaneous bilateral radiofrequency thalamotomy for patients with medication-refractory essential tremor (ET). Essential tremor is a common neurological condition that causes involuntary shaking, often affecting the hands and interfering with daily activities such as writing, eating, or using tools. While medications such as propranolol and primidone can help some patients, others experience limited or no benefit. In this study, five adult participants diagnosed with essential tremor that does not respond to standard medications will undergo simultaneous bilateral stereotactic radiofrequency lesioning of the ventral intermediate nucleus (Vim) of the thalamus. This procedure involves precisely targeting both sides of the Vim to reduce tremor in both arms during a single surgical session. Prior to surgery, participants will undergo brain MRI for surgical planning, as well as clinical evaluations including the Clinical Rating Scale for Tremor (CRST), Quality of Life in Essential Tremor Questionnaire (QUEST), the Scale for the Assessment and Rating of Ataxia (SARA), mood scales (BDI, BAI, AES), and cognitive function testing. The surgery will be performed under local anesthesia using a stereotactic frame and intraoperative imaging. Tremor reduction will be assessed postoperatively and at 1, 3, and 6 months. The primary outcome is the improvement in CRST scores at 6 months. Secondary outcomes include quality of life (QUEST), ataxia symptoms (SARA), mood and cognitive changes, and adverse events. This research is being conducted at Tokyo Women's Medical University. The study is IRB-approved and participants will be monitored closely throughout the 6-month follow-up period. Any complications or adverse events, such as temporary speech or swallowing difficulties, will be recorded and managed appropriately. The goal of this study is to explore whether performing thalamotomy on both sides simultaneously is a safe and effective treatment option for patients with severe and medication-resistant essential tremor.

Key Dates

First listed
Jul 15, 2025
Start date
Jul 3, 2025
Status verified
Jul 2025
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bilateral RF Thalamotomy
    Participants in this arm will undergo simultaneous bilateral radiofrequency lesioning of the ventral intermediate nucleus (Vim) of the thalamus using a stereotactic frame under local anesthesia. The procedure begins with treatment on the side contralateral to the dominant hand. Intraoperative MRI will be performed after the first lesion to confirm the absence of hemorrhagic complications. If no complications are observed, the procedure will continue on the opposite side. If hemorrhage is detected, the surgery will be terminated after unilateral treatment. The goal of this intervention is to reduce medication-refractory tremor in both upper limbs.

Primary Outcome Measure

Change in Clinical Rating Scale for Tremor (CRST) Score From Baseline to 6 Months Postoperatively [ Time Frame: Baseline and 6 Months After Surgery ]

Central Contacts

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