Introduction

Raynaud's phenomenon (RP) is an episodic vasospasm of the peripheral arteries that causes cyanosis, erythema, pain, paraesthesia’s, and sometimes ulceration of the fingers and/or toes¹. There are few reports, mostly case series, on the benefits of spinal cord stimulation (SCS) for the treatment of RP^2–19. However, there is a lack of objective evidence on SCS induced modulation of the sympathetic system (e.g., vasodilation) in this condition.

We hypothesize that evoked compound action potential-(ECAP)-controlled closed-loop-SCS may relieve pain and reduce the severity and frequency of Raynaud's attacks. Furthermore, we hypothesize that the retrograde effects of ECAP-controlled closed-loop-SCS may improve peripheral blood flow. Here, objective results on the effects on peripheral circulation and subjective changes in the frequency and severity of Raynaud's attacks will be presented. Full cohort data will be introduced at eINS.

Materials / Methods

This is a prospective, single-centre pilot study to evaluate the efficacy of ECAP-controlled closed-loop-SCS (Evoke® SmartSCS^TM, Saluda Medical, Australia) in the treatment of RP. Patient outcomes such as Raynaud severity/condition score, Cochin-Hand-Function-Scale, SHAQ-RP-VAS, EQ-5D-5L, PGIC, stimulation parameters, objective peripheral blood flow assessments and neurophysiological measurements were collected at baseline, trial end, 1-month, 3-months, and 6-months.

Results

The mean age ±standard deviation (±SD) patients was 45.5±15.5 years (n=10), and 80% were female.

Fig.1A shows an occluded distal digital artery due to RP, whereas Fig.1B shows the same section after 3-months of SCS, revealing blood flow restoration at the level of the Distal interphalangeal joint.

Pathological arterial occlusions decreased by 49% (n=8; Fig.1C) at 6-months after implantation.

Recording and measurement of patients' ECAPs in the clinic are presented in Fig.1D. The Voltage (µV) increased with increasing current.

The mean baseline (±SEM; n=9) Raynaud's condition score was 6.6±0.7 and decreased to 2.6±0.7 6-months after implantation (n=8; Fig.2A). Patients experienced a clinically meaningful change in symptom severity as informed by the Raynaud's condition score (-1.4)²⁰.

The mean baseline (±SEM; n=9) Cochin-Hand-Function-Scale score was 31.6±8.2 and decreased to 17.4±7.7 6-months after implantation (n=8; Fig.2B).

Discussion

This study demonstrates for the first time that RP-related pathological arterial occlusions and Raynaud symptoms can be treated with a novel ECAP-controlled closed-loop-SCS system.

Conclusions

In conclusion, ECAP-controlled closed-loop-SCS alleviates RP symptoms and improves peripheral blood flow. Longer-term follow up and larger controlled studies are needed to confirm these preliminary pilot study results.

References

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Learning Objectives

1. To learn that pathological arterial occlusions in patients with Raynaud’s Phenomenon can be treated with ECAP-controlled closed-loop-SCS.

2. To show that Raynaud symptoms can be treated with ECAP-controlled closed-loop-SCS.

3. To provide that overall assessment of an SCS therapy for chronic neuropathic pain in Raynaud’s Phenomenon requires the implementation of objective and multiple patient-related outcomes measures.