Remotely supervised at-home delivery of taVNS for autism spectrum disorder: feasibility and initial efficacy
BackgroundTranscutaneous auricular vagus nerve stimulation (taVNS) has potential clinical application for autism spectrum disorder (ASD). At-home sessions are necessary to allow delivery of repeated sessions, and remove burden on patients for daily visits, and reduce costs of clinic delivery. Our ob...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-09-01
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| Series: | Frontiers in Psychiatry |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpsyt.2023.1238328/full |
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| author | Benjamin Black Samantha Hunter Hannah Cottrell Roee Dar Nicole Takahashi Bradley J. Ferguson Yishai Valter Eric Porges Eric Porges Eric Porges Abhishek Datta Abhishek Datta David Q. Beversdorf |
| author_facet | Benjamin Black Samantha Hunter Hannah Cottrell Roee Dar Nicole Takahashi Bradley J. Ferguson Yishai Valter Eric Porges Eric Porges Eric Porges Abhishek Datta Abhishek Datta David Q. Beversdorf |
| author_sort | Benjamin Black |
| collection | DOAJ |
| description | BackgroundTranscutaneous auricular vagus nerve stimulation (taVNS) has potential clinical application for autism spectrum disorder (ASD). At-home sessions are necessary to allow delivery of repeated sessions, and remove burden on patients for daily visits, and reduce costs of clinic delivery. Our objective was to validate a protocol for remote supervised administration for home delivery of taVNS using specially designed equipment and platform.MethodsAn open-label design was followed involving administration by caretakers to 12 patients with ASD (ages:7–16). Daily 1-h sessions over 2 weeks were administered under remote supervision. The primary outcome was feasibility, which was assessed by completion rate, stimulation tolerability, and confirmation of programmed stimulation delivery. The secondary measures were initial efficacy assessed by Childhood Anxiety Sensitivity Index-Revised (CASI-R), Parent Rated Anxiety Scale for Youth with ASD (PRAS-ASD), and Clinician Global Impression (CGI) scales. Sleep measures were also tracked using Cleveland Adolescent Sleep Questionnaire (CASQ).ResultsAcross 132 sessions, we obtained an 88.5% completion rate. A total of 22 expected adverse events were reported with headache being the most common followed by transient pain, itchiness, and stinging at the electrode site. One subject dropped out of the study unrelated to the stimulation or the study. Average scores of anxiety (CASI-R, PRAS-ASD, and CGI) and sleepiness (CASQ) were all improved at the 2 week time point. While not powered to determine efficacy, benefits were suggested in this open label pilot.ConclusionRemotely supervised, proxy-administered, at-home delivery of taVNS is feasible in patients with ASD. Initial efficacy supports pursuing larger scale trials. |
| first_indexed | 2024-03-11T21:16:57Z |
| format | Article |
| id | doaj.art-7970b136e3574c25b862ae8a1abb2689 |
| institution | Directory Open Access Journal |
| issn | 1664-0640 |
| language | English |
| last_indexed | 2024-03-11T21:16:57Z |
| publishDate | 2023-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Psychiatry |
| spelling | doaj.art-7970b136e3574c25b862ae8a1abb26892023-09-28T16:58:02ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402023-09-011410.3389/fpsyt.2023.12383281238328Remotely supervised at-home delivery of taVNS for autism spectrum disorder: feasibility and initial efficacyBenjamin Black0Samantha Hunter1Hannah Cottrell2Roee Dar3Nicole Takahashi4Bradley J. Ferguson5Yishai Valter6Eric Porges7Eric Porges8Eric Porges9Abhishek Datta10Abhishek Datta11David Q. Beversdorf12Department of Pediatrics, Thompson Center for Autism and Neurodevelopment, University of Missouri, Columbia, MO, United StatesDepartment of Pediatrics, Thompson Center for Autism and Neurodevelopment, University of Missouri, Columbia, MO, United StatesDepartment of Pediatrics, Thompson Center for Autism and Neurodevelopment, University of Missouri, Columbia, MO, United StatesSchool of Medicine, University of Missouri, Columbia, MO, United StatesDepartment of Pediatrics, Thompson Center for Autism and Neurodevelopment, University of Missouri, Columbia, MO, United StatesDepartment of Neurology, Thompson Center for Autism and Neurodevelopment, University of Missouri, Columbia, MO, United StatesResearch and Development, Soterix Medical, Woodbridge, NJ, United StatesCenter for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United StatesBrain Rehabilitation Research Center, Malcom Randall VAMC, Gainesville, FL, United StatesDepartment of Clinical and Health Psychology, College of Public Health and Health Professions, University of Florida, Gainesville, FL, United StatesResearch and Development, Soterix Medical, Woodbridge, NJ, United StatesDepartment of Biomedical Engineering, City College of New York, New York, NY, United StatesDepartment of Radiology, Neurology, and Psychological Sciences, and the Thompson Center for Autism and Neurodevelopment, University of Missouri-Columbia, Columbia, MO, United StatesBackgroundTranscutaneous auricular vagus nerve stimulation (taVNS) has potential clinical application for autism spectrum disorder (ASD). At-home sessions are necessary to allow delivery of repeated sessions, and remove burden on patients for daily visits, and reduce costs of clinic delivery. Our objective was to validate a protocol for remote supervised administration for home delivery of taVNS using specially designed equipment and platform.MethodsAn open-label design was followed involving administration by caretakers to 12 patients with ASD (ages:7–16). Daily 1-h sessions over 2 weeks were administered under remote supervision. The primary outcome was feasibility, which was assessed by completion rate, stimulation tolerability, and confirmation of programmed stimulation delivery. The secondary measures were initial efficacy assessed by Childhood Anxiety Sensitivity Index-Revised (CASI-R), Parent Rated Anxiety Scale for Youth with ASD (PRAS-ASD), and Clinician Global Impression (CGI) scales. Sleep measures were also tracked using Cleveland Adolescent Sleep Questionnaire (CASQ).ResultsAcross 132 sessions, we obtained an 88.5% completion rate. A total of 22 expected adverse events were reported with headache being the most common followed by transient pain, itchiness, and stinging at the electrode site. One subject dropped out of the study unrelated to the stimulation or the study. Average scores of anxiety (CASI-R, PRAS-ASD, and CGI) and sleepiness (CASQ) were all improved at the 2 week time point. While not powered to determine efficacy, benefits were suggested in this open label pilot.ConclusionRemotely supervised, proxy-administered, at-home delivery of taVNS is feasible in patients with ASD. Initial efficacy supports pursuing larger scale trials.https://www.frontiersin.org/articles/10.3389/fpsyt.2023.1238328/fullautism spectrum disordertVNStaVNSvagus nerve stimulationneuromodulationclinical trial |
| spellingShingle | Benjamin Black Samantha Hunter Hannah Cottrell Roee Dar Nicole Takahashi Bradley J. Ferguson Yishai Valter Eric Porges Eric Porges Eric Porges Abhishek Datta Abhishek Datta David Q. Beversdorf Remotely supervised at-home delivery of taVNS for autism spectrum disorder: feasibility and initial efficacy Frontiers in Psychiatry autism spectrum disorder tVNS taVNS vagus nerve stimulation neuromodulation clinical trial |
| title | Remotely supervised at-home delivery of taVNS for autism spectrum disorder: feasibility and initial efficacy |
| title_full | Remotely supervised at-home delivery of taVNS for autism spectrum disorder: feasibility and initial efficacy |
| title_fullStr | Remotely supervised at-home delivery of taVNS for autism spectrum disorder: feasibility and initial efficacy |
| title_full_unstemmed | Remotely supervised at-home delivery of taVNS for autism spectrum disorder: feasibility and initial efficacy |
| title_short | Remotely supervised at-home delivery of taVNS for autism spectrum disorder: feasibility and initial efficacy |
| title_sort | remotely supervised at home delivery of tavns for autism spectrum disorder feasibility and initial efficacy |
| topic | autism spectrum disorder tVNS taVNS vagus nerve stimulation neuromodulation clinical trial |
| url | https://www.frontiersin.org/articles/10.3389/fpsyt.2023.1238328/full |
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