An interventional study of Vagus Nerve Stimulator in Stroke, Ischemic, sponsored by MGH Institute of Health Professions. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by MGH Institute of Health Professions · Not applicable, Interventional, and Basic science
Paired Vagus Nerve Stimulation (VNS) has been shown to enhance upper extremity motor recovery after ischemic stroke. Prior studies have focused primarily on long-term clinical outcomes, leaving the short-term physiologic response to the intervention poorly understood. The purpose of this study is to examine real-time responses to Vagus Nerve Stimulation (VNS) in individuals with chronic motor impairments after ischemic stroke to better inform Paired VNS dosing. We plan to enroll 50 participants into a single-arm study and perform neurophysiologic assessments during VNS to identify objective markers of stimulation response and examine dose-response relationships.
Participants who have been implanted with a Vagus Nerve Stimulation (VNS) device for motor rehabilitation following ischemic stroke will be recruited after starting clinical Paired VNS therapy. Participants will complete at least one study session during which physiologic responses to VNS will be recorded using electroencephalography (EEG) and pupillometry while stimulation is delivered across a range of intensities (0.0-1.6 mA). These assessments will be used to characterize dose-dependent responses to VNS and identify stimulation parameters associated with the greatest physiologic response. The findings may support the development of individualized approaches to Paired VNS dosing for stroke rehabilitation.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 50 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →MGH Institute of Health Professions is the lead sponsor of 19 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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Contraindication
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VNS applied to the left vagus nerve at a range of stimulation parameters
Device: Vagus Nerve Stimulator
All participants enrolled in the study will receive stimulation across a range of intensities. (Minimum intensity = 0.0 mA, Maximum Intensity = 1.6 mA).
Stimulation Intensity Eliciting Peak Change in Pupil Size
Pupil diameter (mm) will be measured continuously using non-invasive eye-tracking cameras during the study session. For each stimulation intensity (0.0-1.6 mA), VNS-evoked pupil response will be calculated relative to the participant's pre-stimulation baseline pupil size. The magnitude of the pupil response will be quantified at each stimulation intensity for each participant. The stimulation intensity that produces the largest pupil response will be identified for each participant and used as the primary outcome measure.
Time frame: Baseline, Throughout Each Stimulation Block (approx 3 minutes)
Stimulation Intensity Eliciting Peak Change in Aperiodic Slope as measured by Electroencephalogram (EEG) Activity
Cortical EEG activity will be recorded throughout the study session. Changes in EEG activity due to VNS will be analyzed using continuous estimation of the aperiodic slope to identify real-time responses to stimulation. The stimulation intensity evoking the greatest reduction (more shallow) in slope will be used as the secondary outcome measure.
Time frame: Baseline, Throughout Each Stimulation Block (approx 3 minutes)
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Oct 2029, 42 months after the start.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 42 months is above that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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MGH Institute of Health Professions