PARKINSON DISEASE (Disorder)NCT07226284
Effects of Vagal Nerve Stimulation on Leg Muscle Activity and Posture in Parkinson's Disease
A study testing Vagal nerve stimulation in people with PARKINSON DISEASE (Disorder) and Parkinson's Disease (PD), run by University of Minnesota at 1 site in United States.
Trial summary
This study is designed to better understand the mechanisms contributing to impaired activation of leg muscles in people with Parkinson's disease (PD) and to test if stimulation of a nerve at the neck can improve muscle activation, walking and balance. Read more about this study
- Who is it for?
- Ages 21 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Parkinson's Disease (PD)
- What is being tested?
- Vagal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2026to Jan 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 21 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease,
- On stable medication for the preceding month and anticipated over the next 3 months,
- Able to ambulate without the use of an assistive device for more than 50 meters.
- Control Cohort:
- Age (± 3 years) and sex distribution matched to the PD cohort,
- Able to ambulate without the use of an assistive device for more than 50 meters.
Who cannot join
- Failure to demonstrate capacity to consent (based on UBACC and/or MacArthur-CR),
- History of significant neurological disorder (besides PD in the PD group),
- History of stroke, traumatic brain injury, intracranial aneurysm, intracranial hemorrhage, brain tumor or atypical parkinsonian disorder,
- Severe orthopedic or other related musculoskeletal pathology that has significant adverse effects on gait,
- Women who are pregnant or may be pregnant,
- Insufficient comprehension of the English language,
Show all 16Show fewer
- History of substance abuse in past 2 years;
- Additional exclusion criteria for VNS experiment
- Pain at the nVNS treatment site (e.g., dysesthesia, neuralgia, cervicalgia);
- Lesion (including lymphadenopathy), previous surgery (including carotid endarterectomy or vascular neck surgery) or abnormal anatomy at the stimulation site (open wound, rash, infection, swelling, cut, sore, drug patch, surgical scar[s]);
- Known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g., bruits or history of TIA or stroke), congestive heart failure, known severe coronary artery disease or prior myocardial infarction;
- Abnormal baseline electrocardiogram (ECG) within the last year (e.g., second or third-degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation);
- Recent history of uncontrolled high blood pressure, bradycardia, tachycardia, or know recent history orthostatic hypotension;
- Previous unilateral or bilateral vagotomy;
- Implanted metal cervical spine hardware, other metallic implants or implantable medical devices such as deep brain stimulator, hearing aid implant, pacemaker, implanted cardioverter defibrillator, cranial aneurysm and/or cranial aneurysm clips, history of facial/orbital/metallic fragments, implanted electronic device, neurostimulator, valve replacements/stents, metallic implants/prostheses) near the stimulation site such as a bone plate or bone screw;
- History of syncope or seizures (within the last 2 years);
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kristin Garland contact
United States1 site, 1 recruiting
- Recruiting
Movement Disorders Laboratory
Minneapolis, Minnesota, 55414
Kristin Garland, 612-505-6574, garl0038@umn.edu
About this study
Official title: The Effects of Vagus Nerve Stimulation on Intrinsic Lower Leg Spinal Motoneuron Excitability in Parkinson's Disease.
This study is designed to better understand the mechanisms contributing to impaired activation of leg muscles in people with Parkinson's disease (PD) and to test if stimulation of a nerve at the neck can improve muscle activation, walking and balance.
Read the detailed description
The goals of this project are twofold: (i) to test the hypothesis that persistent inward currents (PICs) in spinal motoneurons of the ankle extensors are reduced in people with Parkinson's disease and that these changes are associated with impaired postural control and (ii) to examine the acute effects of non-invasive vagus nerve stimulation (nVNS) on PICs and postural control.
This project will conduct experiments to test the hypothesis that the firing properties of muscles that control the ankle are significantly altered in people with PD compared to matched healthy adults and that these changes in activity are related to the severity of postural control deficits. In addition, this project will examine the acute effects of non-invasive vagal nerve stimulation (nVNS), an intervention that increases activity in the locus coeruleus and raphe nucleus, on the firing properties of ankle muscles and postural control. If successful, this work will be the first to demonstrate that brainstem pathways that control muscle firing properties are altered in people with PD and are associated with postural impairment. The preliminary trial of nVNS will provide evidence that postural muscle activity can be improved with stimulation and improve postural control. These findings will provide critical preliminary data required to move forward with a clinical trial of nVNS in PD.
- Being tested
- Vagal nerve stimulation, No intervention
- Keywords
- nVNS, Vagus nerve, VNS, Parkinson's disease, PD, gammaCore
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagal nerve stimulationDevice
The gammaCore non-invasive vagus nerve stimulator (nVNS) is a hand-held portable device that is used to apply electrical stimulation to the vagus nerve via two electrodes.
No interventionOther
No nVNS is applied in the baseline experiment. Sham nVNS is applied for experiment two
| Study group | Role | What they receive |
|---|---|---|
| Baseline (no VNS) | Other | Within-subject and cross-sectional design that consists of 30 participants with PD (15 with PIGD and 15 without PIGD) and 15 matched controls. Receives: Other: No intervention |
| Real nVNS | Experimental | Not described Receives: Device: Vagal nerve stimulation |
| Sham nVNS | Sham comparator | Sham VNS will be applied using setting that do not active the vagus nerve. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in delta-F
Difference between baseline and post-VNS delta-F measure
Measured: Within-session VNS: 0-60 minutes. Between VNS sessions: 1 - 4 weeks.
Secondary outcomes (4)
Change in Braceheight
Change in brace height measure between before and after VNS
Measured: Within-session VNS: 0 -60 minutes; between VNS sessions: 1-4 weeks
Step length
Average step length
Measured: Within-session VNS: 0-60 minutes; between VNS sessions: 1-4 weeks
Peak magnitude force on step leg
peak magnitude of the step leg loading force during gait initiation
Measured: Within-session VNS: 0-60 minutes; between VNS sessions: 1-4 weeks
Postural sway magnitude
Root mean square (RMS) of the center of pressure smoothness (jerk) in the medial-lateral plane.
Measured: Within-session VNS: 0-60 minutes; between VNS sessions: 1-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start10 Feb 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Experiment one will use both a within-subject and cross-sectional design and experiment two will be a double-blind crossover design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson's Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226284
- Sponsor's protocol ID
- NEUR-2025-34303
- Status last verified
- Oct 2026
- First submitted
- 3 Nov 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mondal B, Choudhury S, Simon B, Baker MR, Kumar H. Noninvasive vagus nerve stimulation improves gait and reduces freezing of gait in Parkinson's disease. Mov Disord. 2019 Jun;34(6):917-918. doi: 10.1002/mds.27662. Epub 2019 Mar 14. No abstract available.
PubMed 30869809Morris R, Yarnall AJ, Hunter H, Taylor JP, Baker MR, Rochester L. Noninvasive vagus nerve stimulation to target gait impairment in Parkinson's disease. Mov Disord. 2019 Jun;34(6):918-919. doi: 10.1002/mds.27664. Epub 2019 Mar 19. No abstract available.
PubMed 30889295Negro F, Muceli S, Castronovo AM, Holobar A, Farina D. Multi-channel intramuscular and surface EMG decomposition by convolutive blind source separation. J Neural Eng. 2016 Apr;13(2):026027. doi: 10.1088/1741-2560/13/2/026027. Epub 2016 Feb 29.
PubMed 26924829Stebbins GT, Goetz CG, Burn DJ, Jankovic J, Khoo TK, Tilley BC. How to identify tremor dominant and postural instability/gait difficulty groups with the movement disorder society unified Parkinson's disease rating scale: comparison with the unified Parkinson's disease rating scale. Mov Disord. 2013 May;28(5):668-70. doi: 10.1002/mds.25383. Epub 2013 Feb 13.
PubMed 23408503Evancho A, Do M, Fortenberry D, Billings R, Sartayev A, Tyler WJ. Vagus nerve stimulation in Parkinson's disease: a scoping review of animal studies and human subjects research. NPJ Parkinsons Dis. 2024 Oct 24;10(1):199. doi: 10.1038/s41531-024-00803-1.
PubMed 39448636Factor SA, Weinshenker D, McKay JL. A possible pathway to freezing of gait in Parkinson's disease. J Parkinsons Dis. 2025 Mar;15(2):282-290. doi: 10.1177/1877718X241308487. Epub 2025 Jan 14.
PubMed 39973500Espay AJ, LeWitt PA, Kaufmann H. Norepinephrine deficiency in Parkinson's disease: the case for noradrenergic enhancement. Mov Disord. 2014 Dec;29(14):1710-9. doi: 10.1002/mds.26048. Epub 2014 Oct 9.
PubMed 25297066Robichaud JA, Pfann KD, Comella CL, Brandabur M, Corcos DM. Greater impairment of extension movements as compared to flexion movements in Parkinson's disease. Exp Brain Res. 2004 May;156(2):240-54. doi: 10.1007/s00221-003-1782-0. Epub 2004 Jan 28.
PubMed 14747885Pfann KD, Buchman AS, Comella CL, Corcos DM. Control of movement distance in Parkinson's disease. Mov Disord. 2001 Nov;16(6):1048-65. doi: 10.1002/mds.1220.
PubMed 11748736Folland JP, Haas B, Castle PC. Strength and activation of the knee musculature in Parkinson's disease: effect of medication. NeuroRehabilitation. 2011;29(4):405-11. doi: 10.3233/NRE-2011-0719.
PubMed 22207069Braak H, Del Tredici K, Rub U, de Vos RA, Jansen Steur EN, Braak E. Staging of brain pathology related to sporadic Parkinson's disease. Neurobiol Aging. 2003 Mar-Apr;24(2):197-211. doi: 10.1016/s0197-4580(02)00065-9.
PubMed 12498954Kim EH, Wilson JM, Thompson CK, Heckman CJ. Differences in estimated persistent inward currents between ankle flexors and extensors in humans. J Neurophysiol. 2020 Aug 1;124(2):525-535. doi: 10.1152/jn.00746.2019. Epub 2020 Jul 15.
PubMed 32667263Hulsey DR, Riley JR, Loerwald KW, Rennaker RL 2nd, Kilgard MP, Hays SA. Parametric characterization of neural activity in the locus coeruleus in response to vagus nerve stimulation. Exp Neurol. 2017 Mar;289:21-30. doi: 10.1016/j.expneurol.2016.12.005. Epub 2016 Dec 14.
PubMed 27988257Gorassini MA, Knash ME, Harvey PJ, Bennett DJ, Yang JF. Role of motoneurons in the generation of muscle spasms after spinal cord injury. Brain. 2004 Oct;127(Pt 10):2247-58. doi: 10.1093/brain/awh243. Epub 2004 Sep 1.
PubMed 15342360Johnson MD, Heckman CJ. Interactions between focused synaptic inputs and diffuse neuromodulation in the spinal cord. Ann N Y Acad Sci. 2010 Jun;1198:35-41. doi: 10.1111/j.1749-6632.2010.05430.x.
PubMed 20536918
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vagus Nerve Stimulation on Intrinsic Lower Leg Spinal Motoneuron Excitability in Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT07226284
- Acronym / sponsor ID
- NEUR-2025-34303
- Keywords
- nVNS, Vagus nerve, VNS, Parkinson's disease, PD, gammaCore
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Parkinson's Foundation
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 10 Nov 2025 (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.
This study is designed to better understand the mechanisms contributing to impaired activation of leg muscles in people with Parkinson's disease (PD) and to test if stimulation of a nerve at the neck can improve muscle activation, walking and balance.
Detailed description
The goals of this project are twofold: (i) to test the hypothesis that persistent inward currents (PICs) in spinal motoneurons of the ankle extensors are reduced in people with Parkinson's disease and that these changes are associated with impaired postural control and (ii) to examine the acute effects of non-invasive vagus nerve stimulation (nVNS) on PICs and postural control.
This project will conduct experiments to test the hypothesis that the firing properties of muscles that control the ankle are significantly altered in people with PD compared to matched healthy adults and that these changes in activity are related to the severity of postural control deficits. In addition, this project will examine the acute effects of non-invasive vagal nerve stimulation (nVNS), an intervention that increases activity in the locus coeruleus and raphe nucleus, on the firing properties of ankle muscles and postural control. If successful, this work will be the first to demonstrate that brainstem pathways that control muscle firing properties are altered in people with PD and are associated with postural impairment. The preliminary trial of nVNS will provide evidence that postural muscle activity can be improved with stimulation and improve postural control. These findings will provide critical preliminary data required to move forward with a clinical trial of nVNS in PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Experiment one will use both a within-subject and cross-sectional design and experiment two will be a double-blind crossover design.
| Arm | Type | Receives |
|---|---|---|
| Baseline (no VNS) | Other | Other: No interventionWithin-subject and cross-sectional design that consists of 30 participants with PD (15 with PIGD and 15 without PIGD) and 15 matched controls. |
| Real nVNS | Experimental | Device: Vagal nerve stimulation |
| Sham nVNS | Sham comparator | Other: No interventionSham VNS will be applied using setting that do not active the vagus nerve. |
Who may qualify
- Ages
- 21 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of idiopathic Parkinson's disease,
- On stable medication for the preceding month and anticipated over the next 3 months,
- Able to ambulate without the use of an assistive device for more than 50 meters.
- Age (± 3 years) and sex distribution matched to the PD cohort,
- Able to ambulate without the use of an assistive device for more than 50 meters.
Key exclusion criteria (16 listed)
- Failure to demonstrate capacity to consent (based on UBACC and/or MacArthur-CR),
- History of significant neurological disorder (besides PD in the PD group),
- History of stroke, traumatic brain injury, intracranial aneurysm, intracranial hemorrhage, brain tumor or atypical parkinsonian disorder,
- Severe orthopedic or other related musculoskeletal pathology that has significant adverse effects on gait,
- Women who are pregnant or may be pregnant,
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 |
|---|---|---|
| Vagal nerve stimulationThe gammaCore non-invasive vagus nerve stimulator (nVNS) is a hand-held portable device that is used to apply electrical stimulation to the vagus nerve via two electrodes. | Device | Real nVNS |
| No interventionNo nVNS is applied in the baseline experiment. Sham nVNS is applied for experiment two | Other | Baseline (no VNS), Sham nVNS |
Primary outcome
Change in delta-F
Time frame: Within-session VNS: 0-60 minutes. Between VNS sessions: 1 - 4 weeks.
Difference between baseline and post-VNS delta-F measure
4 secondary outcomes
Change in Braceheight
Time frame: Within-session VNS: 0 -60 minutes; between VNS sessions: 1-4 weeks
Step length
Time frame: Within-session VNS: 0-60 minutes; between VNS sessions: 1-4 weeks
Peak magnitude force on step leg
Time frame: Within-session VNS: 0-60 minutes; between VNS sessions: 1-4 weeks
Postural sway magnitude
Time frame: Within-session VNS: 0-60 minutes; between VNS sessions: 1-4 weeks
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 20 Oct 2026.
- Background: PubMed 30869809Mondal B, Choudhury S, Simon B, Baker MR, Kumar H. Noninvasive vagus nerve stimulation improves gait and reduces freezing of gait in Parkinson's disease. Mov Disord. 2019 Jun;34(6):917-918. doi: 10.1002/mds.27662. Epub 2019 Mar 14. No abstract available.
- Background: PubMed 30889295Morris R, Yarnall AJ, Hunter H, Taylor JP, Baker MR, Rochester L. Noninvasive vagus nerve stimulation to target gait impairment in Parkinson's disease. Mov Disord. 2019 Jun;34(6):918-919. doi: 10.1002/mds.27664. Epub 2019 Mar 19. No abstract available.
- Background: PubMed 26924829Negro F, Muceli S, Castronovo AM, Holobar A, Farina D. Multi-channel intramuscular and surface EMG decomposition by convolutive blind source separation. J Neural Eng. 2016 Apr;13(2):026027. doi: 10.1088/1741-2560/13/2/026027. Epub 2016 Feb 29.
- Background: PubMed 23408503Stebbins GT, Goetz CG, Burn DJ, Jankovic J, Khoo TK, Tilley BC. How to identify tremor dominant and postural instability/gait difficulty groups with the movement disorder society unified Parkinson's disease rating scale: comparison with the unified Parkinson's disease rating scale. Mov Disord. 2013 May;28(5):668-70. doi: 10.1002/mds.25383. Epub 2013 Feb 13.
- Background: PubMed 39448636Evancho A, Do M, Fortenberry D, Billings R, Sartayev A, Tyler WJ. Vagus nerve stimulation in Parkinson's disease: a scoping review of animal studies and human subjects research. NPJ Parkinsons Dis. 2024 Oct 24;10(1):199. doi: 10.1038/s41531-024-00803-1.
- Background: PubMed 39973500Factor SA, Weinshenker D, McKay JL. A possible pathway to freezing of gait in Parkinson's disease. J Parkinsons Dis. 2025 Mar;15(2):282-290. doi: 10.1177/1877718X241308487. Epub 2025 Jan 14.
- Background: PubMed 25297066Espay AJ, LeWitt PA, Kaufmann H. Norepinephrine deficiency in Parkinson's disease: the case for noradrenergic enhancement. Mov Disord. 2014 Dec;29(14):1710-9. doi: 10.1002/mds.26048. Epub 2014 Oct 9.
- Background: PubMed 14747885Robichaud JA, Pfann KD, Comella CL, Brandabur M, Corcos DM. Greater impairment of extension movements as compared to flexion movements in Parkinson's disease. Exp Brain Res. 2004 May;156(2):240-54. doi: 10.1007/s00221-003-1782-0. Epub 2004 Jan 28.
- Background: PubMed 11748736Pfann KD, Buchman AS, Comella CL, Corcos DM. Control of movement distance in Parkinson's disease. Mov Disord. 2001 Nov;16(6):1048-65. doi: 10.1002/mds.1220.
- Background: PubMed 22207069Folland JP, Haas B, Castle PC. Strength and activation of the knee musculature in Parkinson's disease: effect of medication. NeuroRehabilitation. 2011;29(4):405-11. doi: 10.3233/NRE-2011-0719.
- Background: PubMed 12498954Braak H, Del Tredici K, Rub U, de Vos RA, Jansen Steur EN, Braak E. Staging of brain pathology related to sporadic Parkinson's disease. Neurobiol Aging. 2003 Mar-Apr;24(2):197-211. doi: 10.1016/s0197-4580(02)00065-9.
- Background: PubMed 32667263Kim EH, Wilson JM, Thompson CK, Heckman CJ. Differences in estimated persistent inward currents between ankle flexors and extensors in humans. J Neurophysiol. 2020 Aug 1;124(2):525-535. doi: 10.1152/jn.00746.2019. Epub 2020 Jul 15.
- 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.
Kristin Garland contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagal nerve stimulation in people with PARKINSON DISEASE (Disorder) and Parkinson's Disease (PD), run by University of Minnesota 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 6 inclusion and 16 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 20 Oct 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. Some participants in this study may receive a placebo. 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 Principal Investigator (612-625-8938, cmackinn@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in delta-F (time frame: Within-session VNS: 0-60 minutes. Between VNS sessions: 1 - 4 weeks.). 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 NCT07226284, which also lists 18 linked publications.
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 20 Oct 2026.