ImpACT24-B: Novel stimulation therapy safely treats acute ischemic stroke
Sphenopalatine ganglion stimulation was safe when used in patients with acute ischemic stroke 8 to 24 hours after onset, according to findings from the ImpACT24-B trial presented at the European Stroke Organization Conference.
The technology also was associated with a trend toward improved functional outcome in patients with confirmed cortical involvement, according to the findings, which were simultaneously published in The Lancet.
The researchers randomly assigned 1,078 patients with anterior circulation acute ischemic stroke ineligible for reperfusion therapy to sphenopalatine ganglion stimulation or a sham procedure, 1,000 of whom had at least one session of their procedure and were included in the modified intention-to-treat analysis.
Patients assigned sphenopalatine ganglion stimulation had a neurostimulator electrode injected under local anesthesia into the pterygopalatine canal near the sphenopalatine ganglion with the assistance of an image-guided navigation system (Stroke System GuideView, BrainsGate), whereas the control group had sham navigation procedure and a puncture in the mucosa of the upper palate without insertion of a neurostimulator, according to the researchers.
The primary efficacy endpoint was improvement in disability level above expectations at 3 months. Safety outcomes of interest, all at 3 months, included all serious adverse events, serious adverse events related to implantation, removal or stimulation, and neurological deterioration and mortality.
The researchers also analyzed the 52% of the modified intention-to-treat cohort that had cortical involvement confirmed on imaging.
The primary efficacy outcome was met in 49% of the intervention group and 45% of the control group (OR = 1.14; 95% CI, 0.89-1.46), Natan M. Bornstein, MD, director of the brain division at Shaare-Zedek Medical Center in Jerusalem, and colleagues found.
In the cohort with confirmed cortical involvement, the primary efficacy endpoint was met in 50% of the intervention group and 40% of the control group (OR = 1.48; 95% CI. 1.05-2.1), according to the researchers.
In the confirmed cortical involvement subgroup, there was a U-shaped curve for the primary efficacy outcome, with a favorable result in 70% of those at low to midrange stimulation intensity, compared with approximately 40% in those at low or high stimulation levels (P = .0034), the researchers wrote.
There was no difference between the groups in any of the safety outcomes.
“Pooled analysis of all completed trials indicated that, among patients with imaging evidence of cortical involvement at presentation, sphenopalatine ganglion stimulation improves functional outcome,” Bornstein and colleagues wrote in The Lancet. “These findings provide support for the introduction into clinical practice of sphenopalatine ganglion stimulation for acute ischemic stroke in patients with [confirmed cortical involvement].” – by Erik Swain
Bornstein NM, et al. Large Clinical Trials 2. Presented at: European Stroke Organization Conference; May 22-24, 2019; Milan.
Disclosures: The study was funded by BrainsGate. Bornstein reports he received personal fees and institutional research funding from BrainsGate. Please see the study for the other authors’ relevant financial disclosures.