Around seven million people in the US are affected by essential tremor. Image credit: Momentum studio via Shutterstock.

美国约有七百万人受到原发性震颤的影响。图片来源：Momentum studio 通过 Shutterstock。

Fasikl has reported breakthrough data showing its Felix NeuroAI wristband could offer a promising new non-invasive treatment for individuals with essential tremor.

Fasikl报告了突破性数据，显示其Felix NeuroAI腕带可能为特发性震颤患者提供一种有前景的非侵入性治疗方案。

Using artificial intelligence (AI), the Minneapolis-based company’s investigational wearable wristband, Felix NeuroAI, continuously adapts stimulation based on real-time feedback to provide patients with personalised therapy for essential tremor.

利用人工智能 (AI)，这家总部位于明尼阿波利斯的公司的试验性可穿戴腕带 Felix NeuroAI 能够根据实时反馈持续调整刺激，为特发性震颤患者提供个性化的治疗。

The TRANQUIL study enrolled 125 adults at 12 clinical sites in the US and China, with participants randomised 2:1 to receive either the Felix NeuroAI wristband or a sham device for 90 days. The study’s primary endpoint was change in the modified Activities of Daily Living (mADL) score from the Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS)..

TRANQUIL 研究在美国和中国的 12 个临床站点招募了 125 名成人，参与者按 2:1 的比例随机分配，接受 Felix NeuroAI 手环或假装置治疗 90 天。研究的主要终点是根据震颤研究组特发性震颤评定量表 (TETRAS) 改良的日常生活活动 (mADL) 评分的变化。

In the multicentre, double-blind, sham-controlled trial, patients who wore the device over a 90-day period experienced a clinically significant improvement in essential tremor treatment, meeting the trial’s primary endpoint with a mean reduction of 6.9 points on the mADL scale versus 2.7 points in the sham control group..

在多中心、双盲、假对照试验中，佩戴该设备超过90天的患者在特发性震颤治疗方面经历了具有临床意义的改善，达到了试验的主要终点，与假对照组相比，mADL量表平均降低6.9点，而假对照组则为2.7点。

The device’s efficacy benefits were consistent across age, gender, tremor severity, and essential tremor medication use, with patients in the treatment group reporting greater symptom improvement and more substantial quality of life scores versus the control group. No serious device-related adverse events were reported..

该设备的疗效在年龄、性别、震颤严重程度和是否使用特发性震颤药物方面表现一致，治疗组的患者报告症状改善更明显，生活质量评分也较对照组有更大提升。未报告与设备相关的严重不良事件。

The company presented the trial results at the 2025 American Academy of Neurology (AAN) Meeting, taking place in San Diego between 5-9 April.

公司在2025年4月5日至9日于圣地亚哥举行的美国神经病学学会（AAN）会议上公布了试验结果。

Joyce Rider, professor of neurology at the University of Kansas School of Medicine and principal investigator on the TRANQUIL study said: “The TRANQUIL study represents what could be a shift in how we approach essential tremor treatment, a condition for which new options are sorely needed.

乔伊斯·莱德，堪萨斯大学医学院神经病学教授，同时也是TRANQUIL研究的首席研究员表示：“TRANQUIL研究代表了我们治疗特发性震颤的方法可能会发生转变，因为这种疾病急需新的治疗选择。”

“Although oral medications are often used to treat essential tremor, they can be frequently unsatisfactory, and while deep brain stimulation and focused ultrasound are effective, they require surgical intervention.”

“虽然口服药物常用于治疗特发性震颤，但它们往往令人不满意，而尽管深部脑刺激和聚焦超声波有效，却需要进行手术干预。”

Essential tremor is characterised by involuntary rhythmic contractions and relaxations of certain muscle groups in one or more body parts of the body. While similar symptoms present in Parkinson’s disease patients, essential tremor is a distinct condition.

原发性震颤的特征是身体一个或多个部位的某些肌肉群不自主的节律性收缩和放松。尽管帕金森病患者也会出现类似症状，但原发性震颤是一种独特的疾病。

Around

周围

seven million individuals

七百万个体

are living with essential tremor in the US. Several devices for treating the condition have been cleared by the US Food and Drug Administration (FDA), including Insightec’s Exablate Neuro platform that uses focused ultrasound waves to precisely target and ablate tissue deep within the brain, and

在美国，有相当数量的人患有特发性震颤。美国食品药品监督管理局（FDA）已经批准了几种治疗该疾病的设备，包括Insightec的Exablate Neuro平台，该平台使用聚焦超声波精确瞄准并消融大脑深处的组织。

Cala’s wrist-worn device

卡拉的腕戴设备

that individualises the delivery of stimulation via transcutaneous afferent patterned stimulation (TAPS) by sensing each patient’s unique tremor signature.

通过经皮传入模式刺激（TAPS）感知每位患者的独特震颤特征，从而实现刺激传递的个体化。

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