Pharyngeal electrical stimulation for treatment of dysphagia in subacute stroke
Background and Purpose: Dysphagia is common after stroke, associated with increased death and dependency, and treatment options are limited. Pharyngeal electric stimulation (PES) is a novel treatment for poststroke dysphagia that has shown promise in 3 pilot randomized controlled trials. Methods: W...
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| Format: | Article |
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American Heart Association
2016
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| Online Access: | https://eprints.nottingham.ac.uk/35720/ |
| _version_ | 1848795146134487040 |
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| author | Bath, Philip M.W. Scutt, Polly Love, Jo Clavé, Pere Cohen, David Dziewas, Rainer Iversen, Helle K. Ledl, Christian Ragab, Suzanne Soda, Hassan Warusevitane, Anushka Woisard, Virginie Hamdy, Shaheen |
| author_facet | Bath, Philip M.W. Scutt, Polly Love, Jo Clavé, Pere Cohen, David Dziewas, Rainer Iversen, Helle K. Ledl, Christian Ragab, Suzanne Soda, Hassan Warusevitane, Anushka Woisard, Virginie Hamdy, Shaheen |
| author_sort | Bath, Philip M.W. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | Background and Purpose: Dysphagia is common after stroke, associated with increased death and dependency, and treatment options are limited. Pharyngeal electric stimulation (PES) is a novel treatment for poststroke dysphagia that has shown promise in 3 pilot randomized controlled trials.
Methods: We randomly assigned 162 patients with a recent ischemic or hemorrhagic stroke and dysphagia, defined as a penetration aspiration score (PAS) of ≥3 on video fluoroscopy, to PES or sham treatment given on 3 consecutive days. The primary outcome was swallowing safety, assessed using the PAS, at 2 weeks. Secondary outcomes included dysphagia severity, function, quality of life, and serious adverse events at 6 and 12 weeks.
Results: In randomized patients, the mean age was 74 years, male 58%, ischemic stroke 89%, and PAS 4.8. The mean treatment current was 14.8 (7.9) mA and duration 9.9 (1.2) minutes per session. On the basis of previous data, 45 patients (58.4%) randomized to PES seemed to receive suboptimal stimulation. The PAS at 2 weeks, adjusted for baseline, did not differ between the randomized groups: PES 3.7 (2.0) versus sham 3.6 (1.9), P=0.60. Similarly, the secondary outcomes did not differ, including clinical swallowing and functional outcome. No serious adverse device-related events occurred.
Conclusions: In patients with subacute stroke and dysphagia, PES was safe but did not improve dysphagia. Undertreatment of patients receiving PES may have contributed to the neutral result.
Clinical Trial Registration: URL: http://www.controlled-trials.com. Unique identifier: ISRCTN25681641. |
| first_indexed | 2025-11-14T19:27:27Z |
| format | Article |
| id | nottingham-35720 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T19:27:27Z |
| publishDate | 2016 |
| publisher | American Heart Association |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-357202020-05-04T17:52:25Z https://eprints.nottingham.ac.uk/35720/ Pharyngeal electrical stimulation for treatment of dysphagia in subacute stroke Bath, Philip M.W. Scutt, Polly Love, Jo Clavé, Pere Cohen, David Dziewas, Rainer Iversen, Helle K. Ledl, Christian Ragab, Suzanne Soda, Hassan Warusevitane, Anushka Woisard, Virginie Hamdy, Shaheen Background and Purpose: Dysphagia is common after stroke, associated with increased death and dependency, and treatment options are limited. Pharyngeal electric stimulation (PES) is a novel treatment for poststroke dysphagia that has shown promise in 3 pilot randomized controlled trials. Methods: We randomly assigned 162 patients with a recent ischemic or hemorrhagic stroke and dysphagia, defined as a penetration aspiration score (PAS) of ≥3 on video fluoroscopy, to PES or sham treatment given on 3 consecutive days. The primary outcome was swallowing safety, assessed using the PAS, at 2 weeks. Secondary outcomes included dysphagia severity, function, quality of life, and serious adverse events at 6 and 12 weeks. Results: In randomized patients, the mean age was 74 years, male 58%, ischemic stroke 89%, and PAS 4.8. The mean treatment current was 14.8 (7.9) mA and duration 9.9 (1.2) minutes per session. On the basis of previous data, 45 patients (58.4%) randomized to PES seemed to receive suboptimal stimulation. The PAS at 2 weeks, adjusted for baseline, did not differ between the randomized groups: PES 3.7 (2.0) versus sham 3.6 (1.9), P=0.60. Similarly, the secondary outcomes did not differ, including clinical swallowing and functional outcome. No serious adverse device-related events occurred. Conclusions: In patients with subacute stroke and dysphagia, PES was safe but did not improve dysphagia. Undertreatment of patients receiving PES may have contributed to the neutral result. Clinical Trial Registration: URL: http://www.controlled-trials.com. Unique identifier: ISRCTN25681641. American Heart Association 2016-05-10 Article PeerReviewed Bath, Philip M.W., Scutt, Polly, Love, Jo, Clavé, Pere, Cohen, David, Dziewas, Rainer, Iversen, Helle K., Ledl, Christian, Ragab, Suzanne, Soda, Hassan, Warusevitane, Anushka, Woisard, Virginie and Hamdy, Shaheen (2016) Pharyngeal electrical stimulation for treatment of dysphagia in subacute stroke. Stroke, 47 (6). pp. 1562-1570. ISSN 0039-2499 Dysphagia : pharyngeal electrical stimulation ; randomized controlled trial ; stroke http://stroke.ahajournals.org/content/47/6/1562.short doi:10.1161/STROKEAHA.115.012455 doi:10.1161/STROKEAHA.115.012455 |
| spellingShingle | Dysphagia : pharyngeal electrical stimulation ; randomized controlled trial ; stroke Bath, Philip M.W. Scutt, Polly Love, Jo Clavé, Pere Cohen, David Dziewas, Rainer Iversen, Helle K. Ledl, Christian Ragab, Suzanne Soda, Hassan Warusevitane, Anushka Woisard, Virginie Hamdy, Shaheen Pharyngeal electrical stimulation for treatment of dysphagia in subacute stroke |
| title | Pharyngeal electrical stimulation for treatment of dysphagia in subacute stroke |
| title_full | Pharyngeal electrical stimulation for treatment of dysphagia in subacute stroke |
| title_fullStr | Pharyngeal electrical stimulation for treatment of dysphagia in subacute stroke |
| title_full_unstemmed | Pharyngeal electrical stimulation for treatment of dysphagia in subacute stroke |
| title_short | Pharyngeal electrical stimulation for treatment of dysphagia in subacute stroke |
| title_sort | pharyngeal electrical stimulation for treatment of dysphagia in subacute stroke |
| topic | Dysphagia : pharyngeal electrical stimulation ; randomized controlled trial ; stroke |
| url | https://eprints.nottingham.ac.uk/35720/ https://eprints.nottingham.ac.uk/35720/ https://eprints.nottingham.ac.uk/35720/ |