Chronic StrokeNCT06716112

Paired Vagus Nerve Stimulation Mechanisms

A study testing Vagus Nerve Stimulation (VNS) Device and Upper Extremity Rehabilitation in people with Chronic Stroke, run by NYU Langone Health at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 22 to 79 years
Conditions the study is for: Chronic Stroke
What is being tested?: Vagus Nerve Stimulation (VNS) Device and Upper Extremity Rehabilitation
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4 participants
Where: 2 sitesUnited States
Study dates: 15 Jul 2025to 30 Apr 2026
Phase: Interventional
Are there results?: None posted in the registry

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 22 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability to provide signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
22-79 years of age
Unilateral supratentorial ischemic stroke that occurred ≥ 12 months prior to enrollment
Upper extremity Fugl-Meyer Assessment score of 20 to 50
Modified Rankin Score of 2, 3, or 4
Meets all clinical criteria for VNS implantation as determined by the PI and clinical care team

Who cannot join

Intracerebral hemorrhage or traumatic brain injury
Deficits in language or attention that interfere with study participation
Severe spasticity (Modified Ashworth > 3)
Psychiatric disorders and/or cognitive impairments that would interfere with study participation, as assessed by medical evaluation
Receiving any therapy (medication or otherwise) that would interfere with VNS, such as drugs that perturb neurotransmitter action (anticholinergics, adrenergic blockers, etc.)
Presence of any other implanted electrical stimulation device

Show all 13Show fewer

Prior injury to vagus nerve
Females of childbearing potential who are either pregnant, lactating, heterosexually active, or planning to become pregnant or heterosexually active during study participation; and who are not using, or will not agree to use, the following medically acceptable birth control methods:* (1) sterilization surgery for women, (2) Surgical Sterilization Implant for Women, (3) sterilization surgery for men, (4) long-acting reversible contraceptives (LARC) - implantable rod and IUD; (5) contraceptive shot/injection every 3 months; (6) oral contraceptives ("The Pill"); (7) contraceptive patch; and (8) vaginal contraceptive ring.
Concurrent participation in another interventional clinical trial
Ferromagnetic metal in head (except dental work) or torso
Persons with a current or past: (a) medical (psychiatric, non-psychiatric) condition, disease, disorder, injury, or disability*; or (b) non-medical situation or circumstance that, in the opinion of the principal investigator, study participation: may pose a significant or undue risk to the person; make it unlikely the person will complete all the study requirements per protocol; or may adversely impact the integrity of the data or the validity of the study results. [*Examples include, but are not limited to, the following types of conditions, diseases or disorders: renal, peripheral vascular, cardiac, endocrinologic (e.g., diabetes), immunologic, psychiatric (e.g., substance use), neurologic (e.g., cognitive), or dysphagia]
Persons with a neck circumference larger than 18.5 inches
As determined by the principal investigator, is under current incarceration or legal detention

Trial locations and contacts

2 sites in 1 country.

United States2 sites

NYU Langone Health
New York, New York, 10016
The University of Texas at Dallas
Richardson, Texas, 75080

Other trials in United States

About this study

Official title: Mechanisms of Paired Vagus Nerve Stimulation (VNS) in Chronic Stroke: a Randomized, Blinded, Sham-controlled, Single-center Mechanistic Trial

In this mechanistic study, 40 individuals with chronic stroke will be implanted with a small vagus nerve stimulation (VNS) device. The study will use a randomized, blinded, crossover design to deliver two conditions in six-week blocks: active VNS or sham VNS, each paired with upper extremity (UE) motor rehabilitation. Assessment visits will occur before and after each block, and will examine neural pathway strength, functional connectivity, and motor and non-motor behaviors. Investigators will test for VNS-induced changes in motor, cognitive, and affective systems, and will identify biomarkers predictive of clinical response.

Conditions: Chronic Stroke
Being tested: Vagus Nerve Stimulation (VNS) Device, Sham VNS Device, Upper Extremity Rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vagus Nerve Stimulation (VNS) DeviceDevice
All patients will be implanted with the ReStore VNS device by an NYU neurosurgeon. During treatment sessions, study personnel will deliver a VNS burst at the completion of a training movement by pressing a button on a smart device, which wirelessly triggers active VNS stimulation.
Sham VNS DeviceDevice
All patients will be implanted with the ReStore VNS device by an NYU neurosurgeon. During treatment sessions, study personnel will deliver a VNS burst at the completion of a training movement by pressing a button on a smart device, which wirelessly triggers sham VNS stimulation.
Upper Extremity RehabilitationBehavioural
Rehabilitation training will be functional and activity-based, focusing on six task categories: reaching and grasping objects, gross movements with objects, flipping objects, inserting objects, self-feeding, and opening and closing containers.
Three 90-minute training sessions per week will be administered by a licensed occupational therapist, over two six-week treatment blocks. Sessions will be paired with either active or sham VNS administration.

Study groups in NCT06716112
Study group	Role	What they receive
Active VNS first, then Sham VNS	Experimental	Patients will undergo two 6-week intervention blocks, receiving active VNS first and sham VNS second. Blocks consist of three 90-minute sessions per week with a licensed occupational therapist (OT). During these sessions, patients will perform rehabilitation training activities paired with active VNS during the first block and paired with sham VNS during the second block. Receives: Device: Vagus Nerve Stimulation (VNS) Device; Device: Sham VNS Device; Behavioral: Upper Extremity Rehabilitation
Sham VNS first, then Active VNS	Experimental	Patients will undergo two 6-week intervention blocks, receiving sham VNS first and active VNS second. Blocks consist of three 90-minute sessions per week with a licensed occupational therapist (OT). During these sessions, patients will perform rehabilitation training activities paired with sham VNS during the first block and paired with active VNS during the second block. Receives: Device: Vagus Nerve Stimulation (VNS) Device; Device: Sham VNS Device; Behavioral: Upper Extremity Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent change in Ipsilesional CST MEP Size after Active VNS
Ipsilesional corticospinal tract (CST) motor evoked potential (MEP) size measured before and after the treatment block.
Measured: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])
Percent change in Ipsilesional CST MEP Size after Sham VNS
Ipsilesional corticospinal tract (CST) motor evoked potential (MEP) size measured before and after the treatment block.
Measured: Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])

Secondary outcomes (8)

Percent change in Ipsilesional CReST MEP Size after Active VNS
Ipsilesional corticoreticulospinal tract (CReST) motor evoked potential (MEP) size measured before and after the treatment block.
Measured: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])
Percent change in Ipsilesional CReST MEP Size after Sham VNS
Ipsilesional corticoreticulospinal tract (CReST) motor evoked potential (MEP) size measured before and after the treatment block.
Measured: Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])
Percent Change in Arm Strength after Active VNS
Measured: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])
Percent Change in Arm Strength after Sham VNS
Measured: Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])
Percent Change in Motor Control after Active VNS
Measured: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])
Percent Change in Motor Control after Sham VNS
Measured: Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])
Percent Change in Individuation after Active VNS
Measured: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])
Percent Change in Individuation after Sham VNS
Measured: Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202530 Apr 2026

First posted4 Dec 2024
Study start15 Jul 2025
Primary completion30 Apr 2026
Study completion30 Apr 2026

Why it stopped: The study was terminated because the investigational device could no longer be provided for study purposes, precluding further trial conduct.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic StrokeStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06716112
Sponsor's protocol ID: 24-00751
Status last verified: Jun 2026
First submitted: 29 Nov 2024
Last updated: 12 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Heidi.schambra@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mechanisms of Paired Vagus Nerve Stimulation (VNS) in Chronic Stroke: a Randomized, Blinded, Sham-controlled, Single-center Mechanistic Trial
ClinicalTrials.gov ID: NCT06716112
Acronym / sponsor ID: 24-00751
Conditions: Chronic Stroke
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated because the investigational device could no longer be provided for study purposes, precluding further trial conduct.
Enrolment: 4 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), The University of Texas at Dallas
Study start: 15 Jul 2025 (actual)
Primary completion: 30 Apr 2026 (actual)
Study completion: 30 Apr 2026 (actual)
First posted: 4 Dec 2024 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active VNS first, then Sham VNS	Experimental	Device: Vagus Nerve Stimulation (VNS) Device, Device: Sham VNS Device, Behavioral: Upper Extremity RehabilitationPatients will undergo two 6-week intervention blocks, receiving active VNS first and sham VNS second. Blocks consist of three 90-minute sessions per week with a licensed occupational therapist (OT). During these sessions, patients will perform rehabilitation training activities paired with active VNS during the first block and paired with sham VNS during the second block.
Sham VNS first, then Active VNS	Experimental	Device: Vagus Nerve Stimulation (VNS) Device, Device: Sham VNS Device, Behavioral: Upper Extremity RehabilitationPatients will undergo two 6-week intervention blocks, receiving sham VNS first and active VNS second. Blocks consist of three 90-minute sessions per week with a licensed occupational therapist (OT). During these sessions, patients will perform rehabilitation training activities paired with sham VNS during the first block and paired with active VNS during the second block.

Who may qualify

Ages: 22 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Ability to provide signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
22-79 years of age
Unilateral supratentorial ischemic stroke that occurred ≥ 12 months prior to enrollment
Upper extremity Fugl-Meyer Assessment score of 20 to 50

Key exclusion criteria (13 listed)

Intracerebral hemorrhage or traumatic brain injury
Deficits in language or attention that interfere with study participation
Severe spasticity (Modified Ashworth > 3)
Psychiatric disorders and/or cognitive impairments that would interfere with study participation, as assessed by medical evaluation
Receiving any therapy (medication or otherwise) that would interfere with VNS, such as drugs that perturb neurotransmitter action (anticholinergics, adrenergic blockers, etc.)

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 Stimulation (VNS) DeviceAll patients will be implanted with the ReStore VNS device by an NYU neurosurgeon. During treatment sessions, study personnel will deliver a VNS burst at the completion of a training movement by pressing a button on a smart device, which wirelessly triggers active VNS stimulation.	Device	Active VNS first, then Sham VNS, Sham VNS first, then Active VNS
Sham VNS DeviceAll patients will be implanted with the ReStore VNS device by an NYU neurosurgeon. During treatment sessions, study personnel will deliver a VNS burst at the completion of a training movement by pressing a button on a smart device, which wirelessly triggers sham VNS stimulation.	Device	Active VNS first, then Sham VNS, Sham VNS first, then Active VNS
Upper Extremity RehabilitationRehabilitation training will be functional and activity-based, focusing on six task categories: reaching and grasping objects, gross movements with objects, flipping objects, inserting objects, self-feeding, and opening and closing containers. Three 90-minute training sessions per week will be administered by a licensed occupational therapist, over two six-week treatment blocks. Sessions will be paired with either active or sham VNS administration.	Behavioural	Active VNS first, then Sham VNS, Sham VNS first, then Active VNS

Primary outcome

Percent change in Ipsilesional CST MEP Size after Active VNS
Time frame: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])
Ipsilesional corticospinal tract (CST) motor evoked potential (MEP) size measured before and after the treatment block.
Percent change in Ipsilesional CST MEP Size after Sham VNS
Time frame: Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])
Ipsilesional corticospinal tract (CST) motor evoked potential (MEP) size measured before and after the treatment block.

8 secondary outcomes

Percent change in Ipsilesional CReST MEP Size after Active VNS
Time frame: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])
Percent change in Ipsilesional CReST MEP Size after Sham VNS
Time frame: Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])
Percent Change in Arm Strength after Active VNS
Time frame: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])
Percent Change in Arm Strength after Sham VNS
Time frame: Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])
Percent Change in Motor Control after Active VNS
Time frame: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])
Percent Change in Motor Control after Sham VNS
Time frame: Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])
Percent Change in Individuation after Active VNS
Time frame: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])
Percent Change in Individuation after Sham VNS
Time frame: Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])

Results and safety

The study was stopped early (reason given: The study was terminated because the investigational device could no longer be provided for study purposes, precluding further trial conduct.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Heidi.schambra@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

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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. This study is not recruiting at the moment.

Heidi Schambra, MD principal investigator

NYU Langone Health

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vagus Nerve Stimulation (VNS) Device and Upper Extremity Rehabilitation in people with Chronic Stroke, run by NYU Langone Health at 2 sites 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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in Ipsilesional CST MEP Size after Active VNS (time frame: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06716112.

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 12 Jun 2026.