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    Interventional procedure overview of pharyngeal electrical stimulation for neurogenic dysphagia

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    Efficacy summary

    Decannulation

    The PHAST-TRAC RCT (Dziewas, 2018) found a statistically significant effect that people who had PES had a higher likelihood of readiness for decannulation 24 to 72 hours after treatment (49% [17/35]) compared with sham (9% [3/34]; OR=7·00 [95% CI 2·4–19·8]; p=0·0008). This was a crossover trial, meaning that people in the sham arm who were not decannulated within the first 24 to 72 hours were then treated with PES. Of the 30 people who crossed over to receive PES, 53% (16/30) were ready for decannulation within 24 to 72 hours. No one who was decannulated was recannulated within 30 days or before hospital discharge.

    In the RCT of 30 people (Suntrup, 2015) there was a statistically significantly higher likelihood of decannulation within 72 hours of treatment completion in the PES group (75% [15/20]) compared with sham (20% [2/10]; p<0.01). This was also a crossover trial, and 71% (5/8) of patients in the sham group who had severe persistent dysphagia and went on to receive PES were ready for decannulation 72 hours after treatment.

    In the PHADER prospective registry study (Bath, 2020), 66% (66/99) of people with tracheostomy could be decannulated after PES. The magnitude of improvement at 3 months was greater (7.5 versus 2.1 points on the DSRS) in the decannulated group compared with the non-decannulated group (note MCID=1). From the data presented it was not possible to see the split of participants who were decannulated into those who had had a stroke and those who had not had a stroke.

    Overall treatment effect

    In a meta-analysis of 8 randomised controlled trials (RCTs), there was a statistically significant overall moderate effect size of PES compared with sham with substantial heterogeneity: standardised mean difference (SMD) 0.68 (95% confidence interval [CI] 0.22 to 1.14; p=0.004; I2=65%). Further meta-analyses were done for early (up to 2 weeks) and late (3 months or more) treatment effects (Cheng, 2021):

    • Early (8 studies): there was a statistically significant overall moderate effect size of PES compared with sham with substantial heterogeneity: SMD 0.68 (95% CI 0.22 to 1.14; p=0.004; I2=65%).

    • Late (2 studies): there was no statistically significant effect size of PES compared with sham with no heterogeneity: SMD -0.04 (95% CI -0.46 to 0.38; p=0.86; I2=0%).

    The authors note that the number of studies that published data on late treatment effect was limited. Interpretation of the overall treatment effect reported in this meta-analysis is challenging because multiple outcome measures (percentage of people decannulated, PAS, DSRS) were combined in the description of 'overall treatment effect'.

    Swallowing outcomes

    PAS

    In a meta-analysis of 5 RCTs, treatment with PES had a statistically significant moderate effect size on PAS scores from before to after treatment: effect size 0.527 (z(4)=3.983, p=0.000, 95% CI 0.268 to 0.786). When comparing the change in PAS score between PES and sham groups, there was no statistically significant difference in PAS score change from baseline to after treatment (z(4)=0.718, p=0.473, Hedges' g=0.099, and 95% CI -0.170 to 0.368; Speyer 2022).

    In an RCT of 162 people (87 active treatment) with post-stroke dysphagia, there were no statistically significant differences in the change in PAS score from baseline to 2 weeks or 12 weeks in PAS scores between the PES and sham groups (Bath 2016):

    • 2 weeks: mean difference=0.14; 95% CI -0.37 to 0.64; p=0.60

    • 12 weeks: mean difference=0.29; 95% CI -0.04 to 0.99; p=0.41.

    In an analysis of a prospective registry of 252 people with dysphagia from various neurological causes, there was a statistically significant decrease in PAS score from 6.7 at baseline to 3.2 at day 92 after PES treatment (mean difference -4.1; 95% CI -4.8 to -3.3; p<0.001). Similar decreases were observed in diagnostic subgroups (stroke, not ventilated; stroke, ventilated, ventilator-related, but not observed in TBI; Bath 2020).

    In a pilot RCT of 20 people (10 active treatment) with dysphagia related to multiple sclerosis (MS), there was a statistically significant decrease in PAS score from baseline to each post-stimulation period (p<0.001). A similar decrease was not observed in the sham group (Restivo 2013).

    In a pilot RCT of 20 people (10 people PES plus standard logopaedic therapy [SLT]) with dysphagia related to ALS, there were no statistically significant differences in PAS score improvement between the PES plus SLT and SLT alone treatment groups at any of the follow-up visits (all p>0.05; Herrmann 2022).

    DSRS

    In the RCT of 162 people (87 on active treatment) with post-stroke dysphagia, there were no statistically significant differences in the change in DSRS score from baseline to 2 weeks or 12 weeks between the PES and sham groups (Bath 2016):

    • 2 weeks: mean difference 0.31; 95% CI -0.56 to 1.18; p=0.49

    • 12 weeks: mean difference 1.01; 95% CI -0.44 to 2.46; p=0.17.

    In an RCT of 69 people (35 on active treatment) with post-stroke dysphagia and tracheostomy, there were no statistically significant differences in the change in DSRS score from baseline to 2 days, 30 days (or hospital discharge, whichever was first), or 90 days after treatment between the PES and sham groups. Note that this RCT was stopped early for superiority in the primary outcome (readiness for decannulation; Dziewas 2018):

    • baseline DSRS: PES 12, sham 12

    • 2 days: mean difference 0.27; 95% CI -1.05 to 1.59; p=0.6873

    • 30 days (or hospital discharge): mean difference
      -0.88; 95% CI -3.17 to 1.41; p=0.4437

    • 90 days: mean difference -1.10; 95% CI -3.97, 1.77; p=0.4449.

    In the analysis of a prospective registry of 252 people with dysphagia from various neurological causes, there was a statistically significant decrease in DSRS score from 11.4 at baseline to 5.1 at day 92 after PES treatment (mean difference -6.3; 95% CI -7.0 to -5.6; p<0.001). Similar decreases were observed in diagnostic subgroups (stroke, not ventilated; stroke, ventilated, ventilator-related, and TBI; Bath 2020).

    In the pilot RCT of 20 people (10 people PES plus SLT) with dysphagia related to ALS, there were no statistically significant differences in DSRS score improvement between the PES plus SLT and SLT alone treatment groups at any of the follow-up visits (all p>0.05; Herrmann 2022).

    FOIS

    In the RCT of 69 people (35 on active treatment) with post-stroke dysphagia and tracheostomy, there were no statistically significant differences in the change in FOIS score from baseline to 2 days, 30 days (or hospital discharge), or 90 days after treatment between the PES and sham groups. Note that this RCT was stopped early for superiority in the primary outcome (readiness for decannulation; Dziewas 2018):

    • baseline FOIS: PES 1, sham 1

    • 2 days: mean difference -0.191; 95% CI -0.878 to 0.495; p=0.5789

    • 30 days (or hospital discharge): mean difference 0.560; 95% CI -0.61 to 1.73; p=0.3407

    • 90 days: mean difference 0.745, 95% CI -0.660 to 2.150; p=0.2922.

    In the analysis of a prospective registry of 252 people with dysphagia from various neurological causes, there was a statistically significant increase in FOIS score from 1.4 at baseline to 4.3 at day 92 after PES treatment (mean difference 2.9; 95% CI 2.5 to 3.3; p<0.001). Similar increases were observed in diagnostic subgroups (stroke, not ventilated; stroke, ventilated, ventilator-related, but not observed in TBI; Bath 2020).

    Leaking and residues

    In the pilot RCT of 20 people (10 people PES plus SLT) with dysphagia related to ALS, there were no statistically significant differences in leaking and residues between the PES plus SLT and SLT alone treatment groups at any of the follow‑up visits (all p>0.05). Residues are parts of the bolus that remain in the pharynx after swallowing and put the patient at risk of aspiration. Leaking is when solid or fluid food enters the pharynx before triggering the swallowing reflex (Herrmann 2022).

    Dependence/disability outcomes

    NIHSS

    In the RCT of 162 people (87 on active treatment) with post-stroke dysphagia, there was no statistically significant difference in the change from baseline to 2 weeks in NIHSS scores between the PES and sham groups (Bath 2016): at 2 weeks the mean difference was -0.05; 95% CI -1.42 to 1.32; p=0.94.

    In the RCT of 69 people (35 on active treatment) with post-stroke dysphagia and tracheostomy, there were no statistically significant differences in the change in NIHSS score from baseline to 2 days, 30 days (or hospital discharge), or 90 days after treatment between the PES and sham groups. Note that this RCT was stopped early for superiority in the primary outcome (readiness for decannulation; Dziewas 2018):

    • baseline NIHSS score: PES 17.6, sham 17.5

    • 2 days: mean difference -0.027; 95% CI -3.287 to 3.233; p=0.9867

    • 30 days (or hospital discharge): mean difference 0.292; 95% CI -2.865 to 3.448; p=0.8533

    • 90 days: mean difference -6.750; 95% CI -16.281 to 2.781; p=0.1510.

    mRS

    In the RCT of 162 people (87 active treatment) with post-stroke dysphagia, there was no statistically significant difference in the change from baseline to 2 weeks in mRS scores between the PES and sham groups (Bath 2016): at 2 weeks the mean difference was 0.53; 95% CI 0.23 to 1.22; p=0.14.

    In the RCT of 69 people (35 on active treatment) with post-stroke dysphagia and tracheostomy, there were no statistically significant differences in the change in mRS score from baseline to 2 days, 30 days (or hospital discharge), or 90 days after treatment between the PES and sham groups. Note that this RCT was stopped early for superiority in the primary outcome (readiness for decannulation; Dziewas 2018):

    • baseline NIHSS score: PES 5.0, sham=5.0

    • 2 days: mean difference 0.078; 95% CI -0.570 to 0.727; p=0.8094

    • 30 days (or hospital discharge): mean difference 0.091; 95% CI -0.163 to 0.345; p=0.4769

    • 90 days: mean difference -0.203; 95% CI -0.730 to 0.324; p=0.4421.

    BI

    In the RCT of 162 people (87 active treatment) with post-stroke dysphagia, there was no statistically significant difference in the change from baseline to 2 weeks in BI scores between the PES and sham groups (Bath 2016): at 2 weeks the mean difference was 1.57; 95% CI -3.60 to 6.73; p=0.55.

    Quality of life outcomes

    EQ-5D

    In the RCT of 162 people (87 on active treatment) with post-stroke dysphagia, there were no statistically significant differences in change from baseline in EQ‑5D (as health utility status) or EQ-5D VAS between the PES and sham groups (Bath 2016):

    • EQ-5D (as health utility status): mean difference 0.13; 95% CI 0.00 to 0.27; p=0.054

    • EQ-5D VAS: mean difference -4.17; 95% CI -15.22 to 6.88; p=0.46.

    SWAL-QOL

    In the pilot RCT of 20 people (10 people on PES plus SLT) with dysphagia related to ALS, there were no statistically significant differences in SWAL-QOL scores between the PES plus SLT and SLT alone treatment groups at any of the follow-up visits (all p>0.05; Herrmann 2022).

    ALSFRS-R

    In the pilot RCT of 20 people (10 people PES plus SLT) with dysphagia related to ALS, there were no statistically significant differences in ALSFRS-R scores between the PES plus SLT and SLT alone treatment groups at any of the follow-up visits (all p>0.05; Herrmann 2022).