Department of Neurology, Fixel Institute for Neurological Diseases, University of Florida, Gainesville, Florida, United States of America.
Tremor Other Hyperkinet Mov (N Y). 2022 Jun 14;12:20. doi: 10.5334/tohm.685. eCollection 2022.
There is growing recognition of peripheral stimulation techniques for controlling arm symptoms in essential tremor (ET). Recently, the FDA gave clearance to the Cala system, a device worn around the wrist to treat arm tremors. The Cala system stimulates the sensory afferents of the peripheral nerves with high-frequency pulses. These pulses are delivered to the median and radial nerves alternately at the tremor frequency of the individual patient.
The PubMed database was searched using the terms ("Essential Tremor"[Mesh] OR "essential tremor" [Title/Abstract] OR "tremor" [Title/Abstract]) AND ("peripheral arm stimulation" [Title/Abstract] OR "Cala device" [Title/Abstract] OR "sensory afferent stimulation" [Title/Abstract] OR "afferent stimulation" [Title/Abstract] OR "arm stimulation" [Title/Abstract] OR "peripheral nerve stimulation" [Title/Abstract]).
The search yielded 54 articles. Many studies discussed the rationale and various strategies for peripheral modulation of tremor. While the Cala system was found to be safe and well-tolerated in ET, data on efficacy revealed mixed findings. In a large randomized, blinded trial (n = 77), the primary outcome evaluated with spiral drawing task did not improve but the secondary outcomes reflected by the arm tremor severity and the activities of the daily living score revealed 20-25% improvements. A subsequent trial (n = 323) found that the in-home use of the Cala device led to improvements of similar magnitude lasting for at least three months but the clinical assessments were open-labeled.
Peripheral stimulation techniques are promising therapeutic modalities for treating ET symptoms. Stimulation of sensory afferent nerve fibers at the wrist can potentially modulate the peripheral and central components of the tremor network. Although the Cala system is user-friendly, safe, and well-tolerated, the current clinical evidence on the efficacy is inconsistent and insufficient. Thus, more data is warranted for implementing peripheral nerve stimulation as a standard of care for ET.
The current review discusses the rationale, background, and potential mechanisms for using peripheral arm stimulation devices for treating ET. The Cala system is a wrist-worn peripheral nerve stimulation device that received FDA clearance to treat arm tremors. The current review evaluates the evidence for the safety and efficacy of using the Cala system and similar devices in clinical practice.
人们越来越认识到外周刺激技术可用于控制原发性震颤(ET)患者的手臂症状。最近,FDA 批准了 Cala 系统,这是一种戴在手腕上治疗手臂震颤的设备。Cala 系统通过高频脉冲刺激周围神经的感觉传入纤维。这些脉冲以个体患者的震颤频率交替传递到正中神经和桡神经。
使用术语“(Essential Tremor [Mesh] OR essential tremor [Title/Abstract] OR tremor [Title/Abstract])AND(peripheral arm stimulation [Title/Abstract] OR Cala device [Title/Abstract] OR sensory afferent stimulation [Title/Abstract] OR afferent stimulation [Title/Abstract] OR arm stimulation [Title/Abstract] OR peripheral nerve stimulation [Title/Abstract])”在 PubMed 数据库中进行检索。
搜索结果得到 54 篇文章。许多研究讨论了外周震颤调制的原理和各种策略。虽然 Cala 系统在 ET 中被发现是安全且耐受良好的,但关于疗效的数据显示出混杂的结果。在一项大型随机、双盲试验(n=77)中,使用螺旋绘图任务评估的主要结果没有改善,但反映手臂震颤严重程度和日常生活活动评分的次要结果显示改善了 20-25%。随后的一项试验(n=323)发现,在家中使用 Cala 设备可导致至少三个月的类似幅度的改善,但临床评估是开放标签的。
外周刺激技术是治疗 ET 症状的有前途的治疗方法。刺激手腕处的感觉传入神经纤维可能会调节震颤网络的外周和中枢成分。尽管 Cala 系统易于使用、安全且耐受良好,但目前关于疗效的临床证据不一致且不足。因此,需要更多的数据来将周围神经刺激作为 ET 的标准治疗方法。
本综述讨论了使用外周手臂刺激装置治疗 ET 的原理、背景和潜在机制。Cala 系统是一种获得 FDA 批准的手腕佩戴式周围神经刺激装置,用于治疗手臂震颤。本综述评估了在临床实践中使用 Cala 系统和类似装置的安全性和疗效证据。