Automated Neural Dosing for Fast-Acting Subperception Therapy: Sustained Spinal Cord Stimulation Outcomes from a Multicenter Study.

IF 4.1 2区医学 Q1 CLINICAL NEUROLOGY

Pain and Therapy Pub Date : 2025-07-03 DOI:10.1007/s40122-025-00758-y

Richard Ferro, James North, Andy Kranenburg, Stephen Pyles, Clay Dorenkamp, Jason Poston, John Schneider, Kacey Auten, Edward Goldberg

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引用次数: 0

Abstract

Introduction: Therapy habituation is a barrier to sustained success with spinal cord stimulation (SCS). Fast-acting subperception therapy (FAST) is a low-frequency, subperception waveform that can achieve rapid wash-in pain relief via the surround inhibition mechanism. FAST-Autodose is an automated neural dosing schedule designed to provide effective pain relief while potentially reducing habituation and maintaining therapy within an efficient therapeutic window-thus eliminating the need for manual patient adjustments. We assessed the efficacy of FAST-Autodose and provide preliminary long-term outcomes.

Methods: We conducted a retrospective review of consecutive patients from a multicenter, observational study in the USA who had received SCS and used FAST-Autodose to manage their chronic pain of the low back and/or lower limbs. The numerical rating scale (NRS) evaluated the overall pain intensity until the last follow-up postimplantation.

Results: Data were collected from 73 patients who had used FAST-Autodose for 11.9 ± 6.8 months on average. At the last follow-up visit (average 1.8 ± 1.5 years after implantation), the NRS score for overall pain decreased by 5.1 ± 2.8 points, to a mean of 2.1 ± 2.0 (p < 0.0001) and 69% of patients reported minimal pain (NRS ≤ 2/10). In total, 23 patients had been implanted for more than 3.5 years and had used FAST-Autodose for a mean of 17.7 ± 5.9 months; in these patients, the mean NRS pain score decreased by 6.1 ± 2.0 points to 1.6 ± 1.2 points (p < 0.0001).

Conclusions: FAST-Autodose is a novel, automated, subperception paradigm for SCS. In our study, this program delivered significant and sustained pain relief in patients with chronic low back and/or leg pain who had been implanted with SCS for up to 3.6 years. These preliminary results constitute a promising rationale for larger, prospective studies on the long-term efficacy of FAST-Autodose.

Clinical trial registration: Trial registered at clinicaltrials.gov (ID: NCT01550575).

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快速作用亚知觉治疗的自动神经剂量：来自多中心研究的持续脊髓刺激结果。

治疗习惯化是脊髓刺激（SCS）持续成功的障碍。速效亚知觉治疗（FAST）是一种低频的亚知觉波形，可以通过包围抑制机制实现快速的洗入疼痛缓解。快速-自动给药是一种自动神经给药计划，旨在提供有效的疼痛缓解，同时潜在地减少习惯化，并在有效的治疗窗口内维持治疗，从而消除了患者手动调整的需要。我们评估了FAST-Autodose的疗效，并提供了初步的长期结果。方法：我们对来自美国一项多中心观察性研究的连续患者进行了回顾性研究，这些患者接受了SCS并使用FAST-Autodose治疗腰背部和/或下肢的慢性疼痛。数值评定量表（NRS）评估植入术后最后一次随访的整体疼痛强度。结果：73例患者使用FAST-Autodose，平均11.9±6.8个月。在最后一次随访时（植入后平均1.8±1.5年），总体疼痛的NRS评分下降5.1±2.8分，平均为2.1±2.0分(p)。结论：FAST-Autodose是一种新的、自动化的、亚知觉的SCS治疗范式。在我们的研究中，该项目为植入SCS长达3.6年的慢性腰痛和/或腿部疼痛患者提供了显著和持续的疼痛缓解。这些初步结果为FAST-Autodose长期疗效的更大规模前瞻性研究提供了有希望的依据。临床试验注册：临床试验注册在clinicaltrials.gov （ID: NCT01550575）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pain and Therapy CLINICAL NEUROLOGY-

CiteScore

6.60

自引率

5.00%

发文量

110

审稿时长

6 weeks

期刊介绍： Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.