Trial results for a study investigating autonomic neuromodulation by transcutaneous nerve stimulation in acute ischaemic stroke were posted on ClinicalTrials.gov on 2025-07-14, with 36 participants enrolled.
Background
Ischemic stroke, including thrombotic stroke, is a leading cause of disability and mortality worldwide. Patients often experience autonomic dysfunction or imbalance in the acute phase, which can affect cardiovascular stability and overall recovery. Current management focuses on rapid reperfusion strategies like mechanical thrombectomy. Investigating adjunctive therapies, such as transcutaneous nerve stimulation for autonomic modulation, is important for potentially improving patient outcomes by addressing these physiological imbalances.
Trial design
This completed, sham-controlled randomized trial, designated as Phase NA, enrolled 36 participants. The study investigated autonomic modulation by transcutaneous vagal nerve stimulation in patients with Ischemic Stroke and Thrombotic Stroke requiring mechanical thrombectomy, also considering Autonomic Dysfunction and Autonomic Imbalance. Participants were randomized to either receive stimulation or undergo electrode attachment only (sham control).
Key results
The trial reported several key measurements related to blood pressure variability:
- Blood Pressure Variability (coefficient of variation):
- In the Stimulation group, the mean was 0.106 (Standard Deviation 0.029).
- In the Electrode Attachment Only group, the mean was 0.107 (Standard Deviation 0.027).
- Systolic Blood Pressure Variability (mmHg):
- In the Stimulation group (n=18), the mean was 14 (Standard Deviation 5).
- In the Electrode Attachment Only group (n=18), the mean was 14 (Standard Deviation 4).
- Diastolic Blood Pressure Variability (coefficient of variation):
- In the Stimulation group, the mean was 0.136 (Standard Deviation 0.05).
- In the Electrode Attachment Only group, the mean was 0.127 (Standard Deviation 0.04).
What this means
The results from this small trial indicate that transcutaneous nerve stimulation, as applied in this study, did not lead to substantial differences in blood pressure variability measures compared to sham control in patients with acute ischemic stroke. For both overall blood pressure variability and systolic blood pressure variability, the mean values and standard deviations were very similar between the stimulation and control groups. While a slight numerical difference was observed in diastolic blood pressure variability, without further statistical analysis, it is difficult to ascertain clinical significance. These findings suggest that this specific neuromodulation approach may not significantly impact blood pressure variability in this patient population, at least under the conditions tested in this study.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05417009, titled "Autonomic Neuromodulation by Transcutaneous Nerve Stimulation in Acute Ischaemic Stroke", were posted on 2025-07-14 on clinicaltrials.gov.