TREMOR

本態性振戦は、家族性振戦、特発性振戦、良性振戦とも呼ばれ、患者さんご自身では制御不能なふるえを引き起こすため、日々の生活に大きな影響を与えます。薬物療法で効果が得られない場合、次のステップとして外科的治療が必要になる場合があります。集束超音波はメスを使わず、さらに合併症のリスクを最小限に抑えながらふるえを低減することが期待できる治療法です。

治療はMRIで温度変化をモニタリングしながら、ふるえの原因と考えられる脳内の小さな部位に超音波を正確に集中させます。最初に低強度の超音波周波を照射しますが、その際、患者さんには感覚や副作用の有無を医師に伝えていただきます。その後、医師が患者さん毎に照射部位を微調整していきます。少しずつエネルギーを上げていき、限局的な治療用照射野を作ります十分な治療効果が得られた時点で治療を終了します。

これまでに多くの患者さんで、治療後、すぐの手のふるえの軽減改善が確認されています。これまでに世界中で3,500人以上の患者さんが治療を受けて、今も増え続けています。

安全性に関する情報については、添付文書をご参照ください。

Find a Treatment Center for ET

Or contact Insightec Educators at 1-800-704-6797

治療の原理と
効果について

メスを使わず、回復時間も短い集束超音波治療。安全かつ効果的に本態性振戦の手のふるえの軽減が期待できるこの治療法をご紹介します。

  • メスを使わず底侵襲な治療

    感染症のリスクがほとんどありません。

  • 手のふるえの症状を軽減

    長期間にわたる効果の持続が期待できます。

  • 1回の治療

    1回の治療で症状の軽減が期待できます。

  • 患者さん毎の最適な治療

    1ミリ以下の単位で照射位置を設定可能です。

  • 最小限の合併症リスク

    安全で効果的な治療法です。

  • Safe and Effective

    With minimal side effects.1

Carol’s Documentary

Carol Klein, a lifelong schoolteacher, came to a point in her life where she decided it was time to take control of her shaking hands. She was not going to let Essential Tremor stop her from enjoying life. View Insightec’s documentary about Carol’s incredible journey.

Testimonials may not be representative of all treatment outcomes.

Watch Here

How Is Essential Tremor treated?

From general information about Focused Ultrasound to what a typical treatment day looks like, we are here to help guide you on your journey to tremor treatment. Below we have answered the most frequently asked questions from our patient and caregiver community.

  • What is Focused Ultrasound?
  • Insurance Coverage
  • Am I a Candidate for Focused Ultrasound?
  • Treatment Options for Essential Tremor
  • During and After Treatment
  • Risks and Side Effects

Clinical Study

Overview

Insightec sponsored a clinical trial of the Exablate® Neuro platform to evaluate focused ultrasound to treat patients with medication-refractory Essential Tremor.

The 3-year data demonstrates a durable reduction in hand tremor and improvement in quality of life in subjects who received focused ultrasound for medication-refractory essential tremor.

Efficacy results

3 year follow up pivotal study of focused ultrasound for Essential Tremor¹ (See chart)
Percentages represent tremor improvement over baseline.
1 Pre-Market Approval (PMA) P150038

Safety results

Insightec-sponsored clinical studies have shown that the most common adverse events experienced after treatment included: imbalance/gait disturbance (26%), numbness/tingling (33%), and headache/head pain (51%). Most of these events were classified as mild or moderate, and 48% of all adverse events resolved on their own within 30 days.

Adverse events that persisted at 3 years were all mild or moderate and included: numbness/tingling (9%), imbalance (4%), unsteadiness (4%), gait disturbance (2%), and musculoskeletal weakness (2%). Additional infrequent events include dizziness, taste disturbance, slurred speech, fatigue and vomiting.

The number in parenthesis is the percentage of active subjects experiencing these adverse events.

For additional safety information, please refer to Pre-Market Approval (PMA) P150038

Clinical Study – Second Side Trial

Overview

Insightec sponsored a clinical study of the Exablate® Neuro platform to evaluate focused ultrasound to unilaterally treat the contralateral side for patients with medication-refractory Essential Tremor who had already received an Exablate focused ultrasound index procedure at least 9 months prior.

The 6-month data demonstrates a durable reduction in hand tremor and improvement in quality of life in subjects who received a unilateral focused ultrasound for medication-refractory essential tremor on their contralateral side from the index focus ultrasound thalamotomy.

Efficacy results

6-month follow up study of focused ultrasound for Essential Tremor2 (See chart) Percentages represent tremor improvement over baseline.
2 Pre-Market Approval (PMA) P150038 – S022

Safety results

The most common adverse events, or complications, reported by subjects in Insightec-sponsored clinical studies after treatment included: Ataxia (24% of study patients), numbness/tingling (33%), dysarthria (29% of subjects), dysgeusia (14% of patients), imbalance (10% of patients), unsteadiness (10% of patients), gait disturbance (10% of patients), dysphagia (10% of patients), hypogeusia (10% of patients).

98% of these events were classified as mild (85%) or moderate (13%), and 51% of all adverse events resolved on their own within 6 months. Additional infrequent (<5%) events dysmetria, fatigue, weakness, decrease in synchronicity, dizziness, dry mouth, hypoesthesia, intermittent diplopia, sialorrhea, voice change, facial droop, headache, and UTI.

They were no device related adverse events.

Only one related serious event occurred – a urinary tract infection following use of catheter during the procedure.
For additional safety information for Staged Unilateral Treatment of the Contralateral Side, please refer to Pre-Market Approval P150038 Supplement S022. Again, you should discuss in detail the risks, benefits and treatment options with your physician prior to treatment.

    Safety Information

    Important Safety Information

    You should have a detailed conversation with your physician regarding complications, also known as adverse events, that you may experience.

    Insightec-sponsored clinical studies have shown that the most common adverse events experienced after treatment included: 1) imbalance/gait disturbance (26%), 2) numbness/tingling (33%), and 3) headache/head pain (51%). Most of these events were classified as mild or moderate, and 48% of all adverse events resolved on their own within 30 days.

    Adverse events that persisted at 3 years were all mild or moderate and included: numbness/tingling (9%), imbalance (4%), unsteadiness (4%), gait disturbance (2%), and musculoskeletal weakness (2%). Additional infrequent events include dizziness, taste disturbance, slurred speech, fatigue and vomiting.

    The number in parenthesis is the percentage of active subjects experiencing these adverse events.

    For details of the clinical study methods and results, download Clinical Study Results. For additional safety information, please refer to Pre-Market Approval (PMA) P150038

    Regulatory Approval

    FDA Approved

    The Exablate Neuro is intended for use in the unilateral Thalamotomy treatment of idiopathic Essential Tremor patients with medication-refractory tremor. Patients must be at least age 22. The designated area in the brain responsible for the movement disorder symptoms (ventralis intermedius) must be identified and accessible for targeted thermal ablation by the Exablate device.

    Click here to view the regulatory approvals of Insightec products by country.

    Advocacy
    Partners

    From working diligently toward medical advances, to providing holistic community support, Advocacy groups like the ones below champion both patients and the healthcare professionals treating them.

    • Focused Ultrasound Foundation (FUSF)

      Focused Ultrasound Foundation. FUSF was created to improve the lives of millions of people with serious medical disorders by accelerating the development and adoption of focused ultrasound.

      Visit Website
    • International Essential Tremor Foundation (IETF)

      “Your voice for Essential Tremor”
      The International Essential Tremor Foundation. IETF is a non-profit organization that provides hope to the essential tremor (ET) community worldwide through awareness, education, support, and research.

      Visit Website
    • HOPENET

      HopeNET is a non-profit organization whose purpose is to advocate for, educate, and support those with Essential Tremor.

      Visit Website

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    A Better Tomorrow
    Starts Here

    MRガイド下集束超音波治療による変革

    変革を始める