Evaluation of External Trigeminal Nerve Stimulation to Prevent Cerebral Vasospasm after Subarachnoid Hemorrhage Due to Aneurysmal Rupture: A Randomized, Double-Blind Proof-of-Concept Pilot Trial (TRIVASOSTIM Study)

Philippe Rigoard, Maxime Billot (), Maarten Moens, Lisa Goudman, Hassan El-Hajj, Pierre Ingrand, Amine Ounajim, Manuel Roulaud, Philippe Page, Etienne Babin, Mohamed Et Talby, Jonathan Dany, Simona Johnson, Benoit Bataille, Romain David and Konstantin V. Slavin
Additional contact information
Philippe Rigoard: PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France
Maxime Billot: PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France
Maarten Moens: Department of Neurosurgery, Universitair Ziekenhuis Brussel, 1090 Brussels, Belgium
Lisa Goudman: Department of Neurosurgery, Universitair Ziekenhuis Brussel, 1090 Brussels, Belgium
Hassan El-Hajj: Department of Neuro-Spine & Neuromodulation, Poitiers University Hospital, 86000 Poitiers, France
Pierre Ingrand: CIC 1402, Clinical Investigation Center, Bio-Statistic and Epidemiology, University of Poitiers, 86021 Poitiers, France
Amine Ounajim: PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France
Manuel Roulaud: PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France
Philippe Page: Department of Neuro-Spine & Neuromodulation, Poitiers University Hospital, 86000 Poitiers, France
Etienne Babin: PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France
Mohamed Et Talby: PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France
Jonathan Dany: PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France
Simona Johnson: PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France
Benoit Bataille: Department of Neuro-Spine & Neuromodulation, Poitiers University Hospital, 86000 Poitiers, France
Romain David: PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France
Konstantin V. Slavin: Department of Neurosurgery, University of Illinois at Chicago, Chicago, IL 60612, USA

IJERPH, 2023, vol. 20, issue 10, 1-21

Abstract: Cerebral vasospasm remains the most frequent and devastating complication after subarachnoid aneurysmal hemorrhage because of secondary cerebral ischemia and its sequelae. The underlying pathophysiology involves vasodilator peptide release (such as CGRP) and nitric oxide depletion at the level of the precapillary sphincters of the cerebral (internal carotid artery network) and dural (external carotid artery network) arteries, which are both innervated by craniofacial autonomic afferents and tightly connected to the trigeminal nerve and trigemino-cervical nucleus complex. We hypothesized that trigeminal nerve modulation could influence the cerebral flow of this vascular network through a sympatholytic effect and decrease the occurrence of vasospasm and its consequences. We conducted a prospective double-blind, randomized controlled pilot trial to compare the effect of 10 days of transcutaneous electrical trigeminal nerve stimulation vs. sham stimulation on cerebral infarction occurrence at 3 months. Sixty patients treated for aneurysmal SAH (World Federation of Neurosurgical Societies scale between 1 and 4) were included. We compared the radiological incidence of delayed cerebral ischemia (DCI) on magnetic resonance imaging (MRI) at 3 months in moderate and severe vasospasm patients receiving trigeminal nerve stimulation (TNS group) vs. sham stimulation (sham group). Our primary endpoint (the infarction rate at the 3-month follow-up) did not significantly differ between the two groups ( p = 0.99). Vasospasm-related infarctions were present in seven patients (23%) in the TNS group and eight patients (27%) in the sham group. Ultimately, we were not able to show that TNS can decrease the rate of cerebral infarction secondary to vasospasm occurrence. As a result, it would be premature to promote trigeminal system neurostimulation in this context. This concept should be the subject of further research.

Keywords: subarachnoid hemorrhage; vasospasm; magnetic resonance imaging; delayed cerebral ischemia; brain aneurysm; trigeminal nerve; neurostimulation; TENS; trigemino-cervical complex (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2023
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