Effects of Vagal Nerve Stimulation on Leg Muscle Activity and Posture in Parkinson's Disease
NCT ID: NCT07226284
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
75 participants
INTERVENTIONAL
2026-01-31
2029-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Baseline (no VNS)
Within-subject and cross-sectional design that consists of 30 participants with PD (15 with PIGD and 15 without PIGD) and 15 matched controls.
No intervention
No nVNS is applied in the baseline experiment. Sham nVNS is applied for experiment two
Real nVNS
Vagal nerve stimulation
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.
Sham nVNS
Sham VNS will be applied using setting that do not active the vagus nerve.
No intervention
No nVNS is applied in the baseline experiment. Sham nVNS is applied for experiment two
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vagal nerve stimulation
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 intervention
No nVNS is applied in the baseline experiment. Sham nVNS is applied for experiment two
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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,
* History of substance abuse in past 2 years;
* 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);
21 Years
76 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Parkinson's Foundation
OTHER
Colum MacKinnon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Colum MacKinnon
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Movement Disorders Laboratory
Minneapolis, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Kristin Garland
Role: CONTACT
Phone: 612-505-6574
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Kristin Garland
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Morris 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.
Negro 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.
Stebbins 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.
Evancho 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.
Factor 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.
Espay 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.
Robichaud 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.
Pfann 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.
Folland 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.
Braak 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.
Kim 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.
Hulsey 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.
Gorassini 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.
Johnson 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.
Heckman CJ, Mottram C, Quinlan K, Theiss R, Schuster J. Motoneuron excitability: the importance of neuromodulatory inputs. Clin Neurophysiol. 2009 Dec;120(12):2040-2054. doi: 10.1016/j.clinph.2009.08.009. Epub 2009 Sep 27.
Smulders K, Dale ML, Carlson-Kuhta P, Nutt JG, Horak FB. Pharmacological treatment in Parkinson's disease: Effects on gait. Parkinsonism Relat Disord. 2016 Oct;31:3-13. doi: 10.1016/j.parkreldis.2016.07.006. Epub 2016 Jul 17.
Kerr GK, Worringham CJ, Cole MH, Lacherez PF, Wood JM, Silburn PA. Predictors of future falls in Parkinson disease. Neurology. 2010 Jul 13;75(2):116-24. doi: 10.1212/WNL.0b013e3181e7b688. Epub 2010 Jun 23.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NEUR-2025-34303
Identifier Type: -
Identifier Source: org_study_id