Clinical effectiveness of the sequential 4-channel NMES compared with that of the conventional 2-channel NMES for the treatment of dysphagia in a prospective double-blind randomized controlled study

Kyoung-Ho Seo, Joonyoung Jang, Eun Gyeong Jang, Yulhyun Park, So Young Lee, Bo Ryun Kim, Donghwi Park, Sungwon Park, Hyeoncheol Hwang, Nam Hun Kim, Byung-Mo Oh, Han Gil Seo, Jun Chang Lee, Ju Seok Ryu, Kyoung-Ho Seo, Joonyoung Jang, Eun Gyeong Jang, Yulhyun Park, So Young Lee, Bo Ryun Kim, Donghwi Park, Sungwon Park, Hyeoncheol Hwang, Nam Hun Kim, Byung-Mo Oh, Han Gil Seo, Jun Chang Lee, Ju Seok Ryu

Abstract

Background: To date, conventional swallowing therapies and 2-channel neuromuscular electrical stimulation (NMES) are standard treatments for dysphagia. The precise mechanism of 2-channel NMES treatment has not been determined, and there are controversies regarding the efficacy of this therapy. The sequential 4-channel NMES was recently developed and its action is based on the normal contractile sequence of swallowing-related muscles.

Objective: To evaluate and compare the rehabilitative effectiveness of the sequential 4-channel NMES with that of conventional 2-channel NMES.

Methods: In this prospective randomized case-control study, 26 subjects with dysphagia were enrolled. All participants received 2- or 4-channel NMES for 2-3 weeks (minimal session: 7 times, treatment duration: 300-800 min). Twelve subjects in the 4-channel NMES group and eleven subjects in the 2-channel NMES group completed the intervention. Initial and follow-up evaluations were performed using the videofluoroscopic dysphagia scale (VDS), the penetration-aspiration scale (PAS), the MD Anderson dysphagia inventory (MDADI), the functional oral intake scale (FOIS), and the Likert scale.

Results: The sequential 4-channel NMES group experienced significant improvement in their VDS (oral, pharyngeal, and total), PAS, FOIS, and MDADI (emotional, functional, and physical subsets) scores, based on their pretreatment data. VDS (oral, pharyngeal, and total) and MDADI (emotional and physical subsets) scores, but not PAS and FOIS scores, significantly improved in the 2-channel NMES group posttreatment. When the two groups were directly compared, the 4-channel NMES group showed significant improvement in oral and total VDS scores.

Conclusions: The sequential 4-channel NMES, through its activation of the suprahyoid and thyrohyoid muscles, and other infrahyoid muscles mimicking physiological activation, may be a new effective treatment for dysphagia.

Trial registration: clinicaltrial.gov, registration number: NCT03670498, registered 13 September 2018, https://ichgcp.net/clinical-trials-registry/NCT03670498?term=NCT03670498&draw=2&rank=1 .

Keywords: Deglutition; Dysphagia; Electrical stimulation.

Conflict of interest statement

No commercial party who has a direct financial interest in the results of this research supported this study or will confer some benefit on the authors or any organization with which the authors are associated.

Figures

Fig. 1
Fig. 1
Locations of the electrode attachments. A Channel 1 (right) and channel 2 (left) electrodes were placed superior to the hyoid bone and posterior to the mandible 1 cm away from the midline, and the targeted muscles were the bilateral digastric and mylohyoid muscles. Channel 3 electrodes were placed on the bilateral superior pole of the thyroid cartilage to target the bilateral thyrohyoid muscles, and channel 4 electrodes were placed medial to the sternocleidomastoid muscles and inferior to the thyroid cartilage, and the targeted muscles were the other infrahyoid muscles (sternohyoid, omohyoid, and sternothyroid muscles). B In the 2-channel NMES system, channel 1 and 2 electrodes were attached to the suprahyoid and thyrohyoid muscles, respectively. Other electrodes were attached to the same locations as performed for the 4-channel NMES system, but stimulations were only applied to channel 1 and 2 electrodes
Fig. 2
Fig. 2
Flow of patients through the trial
Fig. 3
Fig. 3
Comparison of initial and follow-up evaluations between the 4-channel and 2-channel NMES groups. A Oral, pharyngeal, and total VDS scores were significantly improved in both groups (p < 0.05). B However, PAS and FOIS scores were significantly improved in the 4-channel NMES group alone after treatment (p < 0.05)

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