Actively Recruiting
Simultaneous Bilateral Radiofrequency Thalamotomy for Medication-Refractory Essential Tremor
Led by Tokyo Women's Medical University · Updated on 2025-07-18
5
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Simultaneous Bilateral Radiofrequency Thalamotomy for Medication-Refractory Essential Tremor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 20 to 70 years
- Diagnosis of essential tremor by a neurologist or neurosurgeon specializing in movement disorders
- Refractory to standard pharmacological therapy such as propranolol, primidone, benzodiazepines, or alprenolol
- Mini-Mental State Examination (MMSE) score of 27 or higher
- Able to undergo MRI
- Provided written informed consent for study participation
You will not qualify if you...
- History or evidence of bleeding tendency
- MRI contraindications such as metallic implants or severe claustrophobia
- Presence of intracranial pathology on preoperative MRI that would interfere with surgery
- Pregnant or breastfeeding individuals
- Any other condition deemed inappropriate by the principal investigator for study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tokyo Women's Medical University, Department of Neurosurgery
Shinjuku-Ku, Tokyo, Japan, 1628666
Actively Recruiting
Research Team
S
SHIRO Horisawa, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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