Simultaneous Bilateral Radiofrequency Thalamotomy for Medication-Refractory Essential Tremor

Launched by TOKYO WOMEN'S MEDICAL UNIVERSITY · Jul 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical treatment for people with essential tremor—a condition that causes uncontrollable shaking, especially in the hands, making everyday tasks like writing or eating difficult. This study focuses on patients whose tremors have not improved with common medications. The surgery being tested is called simultaneous bilateral radiofrequency thalamotomy, which means doctors will carefully target and treat specific areas deep in the brain on both sides during the same operation to try to reduce the shaking in both arms.

Adults between 20 and 70 years old who have been diagnosed with essential tremor that does not get better with standard medicines may be eligible to join. Before surgery, participants will have a brain scan and several tests to check their tremor severity, quality of life, movement coordination, mood, and thinking skills. The surgery is done while the patient is awake but comfortably numbed, using precise imaging to guide the procedure. After the operation, doctors will check how well the tremor improves over six months and watch for any side effects, such as temporary speech or swallowing difficulties. This study is being done in Tokyo and aims to find out if this type of surgery is a safe and effective option for people with severe tremors that don’t respond to medication.

Gender

ALL

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.