Multi-session transcutaneous auricular vagus nerve stimulation for Parkinson's disease: evaluating feasibility, safety, and preliminary efficacy
BackgroundIn pre-clinical animal models of Parkinson's disease (PD), vagus nerve stimulation (VNS) can rescue motor deficits and protect susceptible neuronal populations. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a non-invasive alternative to traditional invasive c...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-07-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2023.1210103/full |
| _version_ | 1797773438056660992 |
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| author | Daniel H. Lench Travis H. Turner Colin McLeod Heather A. Boger Lilia Lovera Lisa Heidelberg Jordan Elm Anh Phan Bashar W. Badran Vanessa K. Hinson |
| author_facet | Daniel H. Lench Travis H. Turner Colin McLeod Heather A. Boger Lilia Lovera Lisa Heidelberg Jordan Elm Anh Phan Bashar W. Badran Vanessa K. Hinson |
| author_sort | Daniel H. Lench |
| collection | DOAJ |
| description | BackgroundIn pre-clinical animal models of Parkinson's disease (PD), vagus nerve stimulation (VNS) can rescue motor deficits and protect susceptible neuronal populations. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a non-invasive alternative to traditional invasive cervical VNS. This is the first report summarizing the safety, feasibility, and preliminary efficacy of repeated sessions of taVNS in participants with PD.ObjectivesTo evaluate the feasibility, safety, and possible efficacy of taVNS for motor and non-motor symptoms in mild to moderate PD.MethodsThis is a double-blind, sham controlled RCT (NCT04157621) of taVNS in 30 subjects with mild to moderate PD without cognitive impairment. Participants received 10, 1-h taVNS sessions (25 Hz, 200% of sensory threshold, 500 μs pulse width, 60 s on and 30 s off) over a 2-week period. Primary outcome measures were feasibility and safety of the intervention; secondary outcomes included the MDS-UPDRS, cognitive function and self-reported symptom improvement.ResultstaVNS treatment was feasible, however, daily in-office visits were reported as being burdensome for participants. While five participants in the taVNS group and three in the sham group self-reported one or more minor adverse events, no major adverse events occurred. There were no group differences on blood pressure and heart rate throughout the intervention. There were no group differences in MDS-UPDRS scores or self-reported measures. Although global cognitive scores remained stable across groups, there was a reduction in verbal fluency within the taVNS group.ConclusionstaVNS was safe, and well-tolerated in PD participants. Future studies of taVNS for PD should explore at-home stimulation devices and optimize stimulation parameters to reduce variability and maximize engagement of neural targets. |
| first_indexed | 2024-03-12T22:05:32Z |
| format | Article |
| id | doaj.art-d36983c6a66943f18bd987cb480dc2e4 |
| institution | Directory Open Access Journal |
| issn | 1664-2295 |
| language | English |
| last_indexed | 2024-03-12T22:05:32Z |
| publishDate | 2023-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj.art-d36983c6a66943f18bd987cb480dc2e42023-07-24T16:02:59ZengFrontiers Media S.A.Frontiers in Neurology1664-22952023-07-011410.3389/fneur.2023.12101031210103Multi-session transcutaneous auricular vagus nerve stimulation for Parkinson's disease: evaluating feasibility, safety, and preliminary efficacyDaniel H. Lench0Travis H. Turner1Colin McLeod2Heather A. Boger3Lilia Lovera4Lisa Heidelberg5Jordan Elm6Anh Phan7Bashar W. Badran8Vanessa K. Hinson9Department of Neurology, Medical University of South Carolina, Charleston, SC, United StatesDepartment of Neurology, Medical University of South Carolina, Charleston, SC, United StatesDepartment of Neurology, Augusta University Medical Center, Augusta, GA, United StatesDepartment of Neurosciences, Medical University of South Carolina, Charleston, SC, United StatesDepartment of Neurology, Medical University of South Carolina, Charleston, SC, United StatesDepartment of Neurology, Medical University of South Carolina, Charleston, SC, United StatesDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC, United StatesDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC, United StatesDepartment of Psychiatry, Medical University of South Carolina, Charleston, SC, United StatesDepartment of Neurology, Medical University of South Carolina, Charleston, SC, United StatesBackgroundIn pre-clinical animal models of Parkinson's disease (PD), vagus nerve stimulation (VNS) can rescue motor deficits and protect susceptible neuronal populations. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a non-invasive alternative to traditional invasive cervical VNS. This is the first report summarizing the safety, feasibility, and preliminary efficacy of repeated sessions of taVNS in participants with PD.ObjectivesTo evaluate the feasibility, safety, and possible efficacy of taVNS for motor and non-motor symptoms in mild to moderate PD.MethodsThis is a double-blind, sham controlled RCT (NCT04157621) of taVNS in 30 subjects with mild to moderate PD without cognitive impairment. Participants received 10, 1-h taVNS sessions (25 Hz, 200% of sensory threshold, 500 μs pulse width, 60 s on and 30 s off) over a 2-week period. Primary outcome measures were feasibility and safety of the intervention; secondary outcomes included the MDS-UPDRS, cognitive function and self-reported symptom improvement.ResultstaVNS treatment was feasible, however, daily in-office visits were reported as being burdensome for participants. While five participants in the taVNS group and three in the sham group self-reported one or more minor adverse events, no major adverse events occurred. There were no group differences on blood pressure and heart rate throughout the intervention. There were no group differences in MDS-UPDRS scores or self-reported measures. Although global cognitive scores remained stable across groups, there was a reduction in verbal fluency within the taVNS group.ConclusionstaVNS was safe, and well-tolerated in PD participants. Future studies of taVNS for PD should explore at-home stimulation devices and optimize stimulation parameters to reduce variability and maximize engagement of neural targets.https://www.frontiersin.org/articles/10.3389/fneur.2023.1210103/fulltranscutaneous auricular vagus nerve stimulationParkinson's diseasevagus nervetaVNSnon-invasive brain stimulation |
| spellingShingle | Daniel H. Lench Travis H. Turner Colin McLeod Heather A. Boger Lilia Lovera Lisa Heidelberg Jordan Elm Anh Phan Bashar W. Badran Vanessa K. Hinson Multi-session transcutaneous auricular vagus nerve stimulation for Parkinson's disease: evaluating feasibility, safety, and preliminary efficacy Frontiers in Neurology transcutaneous auricular vagus nerve stimulation Parkinson's disease vagus nerve taVNS non-invasive brain stimulation |
| title | Multi-session transcutaneous auricular vagus nerve stimulation for Parkinson's disease: evaluating feasibility, safety, and preliminary efficacy |
| title_full | Multi-session transcutaneous auricular vagus nerve stimulation for Parkinson's disease: evaluating feasibility, safety, and preliminary efficacy |
| title_fullStr | Multi-session transcutaneous auricular vagus nerve stimulation for Parkinson's disease: evaluating feasibility, safety, and preliminary efficacy |
| title_full_unstemmed | Multi-session transcutaneous auricular vagus nerve stimulation for Parkinson's disease: evaluating feasibility, safety, and preliminary efficacy |
| title_short | Multi-session transcutaneous auricular vagus nerve stimulation for Parkinson's disease: evaluating feasibility, safety, and preliminary efficacy |
| title_sort | multi session transcutaneous auricular vagus nerve stimulation for parkinson s disease evaluating feasibility safety and preliminary efficacy |
| topic | transcutaneous auricular vagus nerve stimulation Parkinson's disease vagus nerve taVNS non-invasive brain stimulation |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2023.1210103/full |
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