Stroke, IschemicNCT07922200
Biomarkers of Paired VNS
A study testing Vagus Nerve Stimulator in people with Stroke, Ischemic, run by MGH Institute of Health Professions at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Vagus Nerve Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2026to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old and ≤ 80 years old
- Implanted with VNS device for post-stroke motor rehabilitation
- Ability to follow simple commands in English
Who cannot join
- Prior history of developmental, neurologic, or major psychiatric disorder resulting in functional disability
- Visual or auditory disorders limiting ability to participate in study procedures
- Evidence of an uncontrolled seizure disorder
- Patients for whom EEG leads are contraindicated
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MGH Institute of Health Professions
Boston, Massachusetts, 02129
Matthew Picard-Fraser, PT, DPT, 617-643-6564, brainrecoverylab@mghihp.edu
About this study
Official title: Biomarkers of Paired Vagus Nerve Stimulation Therapy for Stroke Motor Rehabilitation
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.
Read the detailed description
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.
- Conditions
- Stroke, Ischemic
- Being tested
- Vagus Nerve Stimulator
- Keywords
- Ischemic Stroke, Stroke, Vagus Nerve Stimulation, Pupillometry, Electroencephalography
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve StimulatorDevice
All participants enrolled in the study will receive stimulation across a range of intensities. (Minimum intensity = 0.0 mA, Maximum Intensity = 1.6 mA).
| Study group | Role | What they receive |
|---|---|---|
| Vagus Nerve Stimulation (VNS) | Experimental | VNS applied to the left vagus nerve at a range of stimulation parameters Receives: Device: Vagus Nerve Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Throughout Each Stimulation Block (approx 3 minutes)
Secondary outcomes (1)
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.
Measured: Baseline, Throughout Each Stimulation Block (approx 3 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start26 Mar 2026
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MGH Institute of Health Professions
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa J Kimberley, MGH Institute of Health Professions
- Investigators
- Teresa J. Kimberley, PhD, PT, Principal investigator, MGH Institute of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922200
- Sponsor's protocol ID
- 2025P002005
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Paired Vagus Nerve Stimulation Therapy for Stroke Motor Rehabilitation
- ClinicalTrials.gov ID
- NCT07922200
- Acronym / sponsor ID
- 2025P002005
- Conditions
- Stroke, Ischemic
- Keywords
- Ischemic Stroke, Stroke, Vagus Nerve Stimulation, Pupillometry, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- MGH Institute of Health ProfessionsUniversity, hospital or other
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vagus Nerve Stimulation (VNS) | Experimental | Device: Vagus Nerve StimulatorVNS applied to the left vagus nerve at a range of stimulation parameters |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old and ≤ 80 years old
- Implanted with VNS device for post-stroke motor rehabilitation
- Ability to follow simple commands in English
Key exclusion criteria (5 listed)
- Prior history of developmental, neurologic, or major psychiatric disorder resulting in functional disability
- Visual or auditory disorders limiting ability to participate in study procedures
- Evidence of an uncontrolled seizure disorder
- Patients for whom EEG leads are contraindicated
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus Nerve StimulatorAll participants enrolled in the study will receive stimulation across a range of intensities. (Minimum intensity = 0.0 mA, Maximum Intensity = 1.6 mA). | Device | Vagus Nerve Stimulation (VNS) |
Primary outcome
Stimulation Intensity Eliciting Peak Change in Pupil Size
Time frame: Baseline, Throughout Each Stimulation Block (approx 3 minutes)
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.
1 secondary outcome
Stimulation Intensity Eliciting Peak Change in Aperiodic Slope as measured by Electroencephalogram (EEG) Activity
Time frame: Baseline, Throughout Each Stimulation Block (approx 3 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teresa J. Kimberley, PhD, PT principal investigator
MGH Institute of Health Professions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus Nerve Stimulator in people with Stroke, Ischemic, run by MGH Institute of Health Professions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brain Recovery Lab Manager (617-643-6564, brainrecoverylab@mghihp.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stimulation Intensity Eliciting Peak Change in Pupil Size (time frame: Baseline, Throughout Each Stimulation Block (approx 3 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.