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Statistical Plan for PES Trial in Post-Stroke DysphagiaTrial to test nerve stimulation for swallowing after stroke

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Key Takeaway
This statistical analysis plan for an ongoing trial will evaluate PES for post-stroke dysphagia; results are pending.

This document describes the statistical analysis plan for an ongoing international, randomized controlled trial. The trial enrolls 650 non-ventilated stroke patients with tube-dependent dysphagia. Participants are randomly assigned to receive either pharyngeal electrical stimulation (PES) daily for six days plus standard care, or standard care alone without PES.

The primary outcome is the Dysphagia Severity Rating Scale (DSRS) measured at days 14 and 90. Secondary outcomes include baseline characteristics, health economics, cognitive function, and extended follow-up to 12 months. The plan details the statistical methods for analyzing these endpoints, including handling of missing data and subgroup analyses.

As this is a statistical analysis plan, no results are available. The trial is ongoing, and the plan serves to pre-specify the analysis approach to ensure transparency and reduce bias. The plan likely covers intention-to-treat principles, adjustment for covariates, and methods for longitudinal data.

The study is conducted internationally, with a sample size of 650, which is adequate to detect clinically meaningful differences in swallowing recovery. The findings will inform clinical practice regarding the use of PES in this patient population.

In summary, this statistical analysis plan outlines a rigorous approach to evaluate the efficacy of PES for post-stroke dysphagia. Results are awaited to determine the intervention's impact on patient outcomes.

How this fits prior evidence

This statistical analysis plan for a randomized trial of pharyngeal electrical stimulation (PES) in post-stroke dysphagia addresses a gap in prior coverage, which focused on other stroke complications and management strategies. Prior coverage noted that infratentorial lesions are associated with 58% dizziness prevalence, individualized blood pressure control did not improve outcomes, higher FIB-4 scores correlate with worse outcomes, conscious sedation was associated with worse outcomes, and community health worker-led interventions reduced systolic blood pressure by 5.5 mm Hg. This trial protocol extends the evidence base by targeting dysphagia, a common and disabling complication, but no results are available yet.

Swallowing problems after a stroke are scary and common. They can turn a simple meal into a struggle, and sometimes force people to rely on feeding tubes. But a new international study is testing a possible way to help: a device that sends gentle electrical pulses to the throat.

The treatment is called pharyngeal electrical stimulation, or PES. In this trial, 650 stroke patients who need a feeding tube because of swallowing trouble will get either PES plus standard care, or just standard care. The PES group receives daily sessions for six days.

The study will track how well patients swallow at day 14 and again at day 90, using a scale called the Dysphagia Severity Rating Scale. The researchers will also look at health costs, thinking skills, and how patients do up to 12 months later.

Right now, this is just a plan for how the study will run. No results are in yet. So we don't know if PES actually helps. But the trial is designed to give a clear answer. If you or someone you love is dealing with post-stroke swallowing issues, this is a study worth watching.

What this means for you:
A large trial is testing if throat nerve stimulation helps stroke patients swallow again.

Common questions

What is pharyngeal electrical stimulation (PES)?

PES is a treatment that uses a small device to send gentle electrical pulses to the throat. The idea is to stimulate the nerves involved in swallowing. In this trial, patients get PES daily for six days, on top of their usual care.

Who is this study for?

This study is for stroke patients who have trouble swallowing and need a feeding tube. Specifically, it includes non-ventilated stroke patients with tube-dependent dysphagia. The trial is international and plans to enroll 650 people.

What does the study measure?

The main thing researchers will measure is how severe the swallowing problem is, using a scale called the Dysphagia Severity Rating Scale. They will check this at day 14 and day 90 after treatment. They will also look at health costs, thinking abilities, and follow patients for up to 12 months.

Are there any results yet?

No. This is a statistical analysis plan, which is a detailed plan for how the study will be analyzed. The trial is still ongoing, and results are not yet available. We will need to wait for the study to finish to know if PES helps.

Study Details

Study typeRct
Sample sizen = 650
EvidenceLevel 2
PublishedAug 2026
View Original Abstract ↓
Introduction Post stroke dysphagia is common, associated with poor functional outcome and lacks treatment strategies beyond behaviour therapies delivered by speech & language therapists. Here, we present the statistical analysis plan for the ongoing pharyngeal electrical stimulation for acute stroke dysphagia trial (PhEAST). PES is a candidate treatment for dysphagia present in non-ventilated stroke patients. Methods PhEAST is an investigator-initiated international prospective randomised open-label blinded-endpoint phase-4 superiority trial involving 650 participants with tube-dependent post-stroke dysphagia. Consenting patients are randomised to PES versus no PES given on top of standard care with PES given daily for 6 days. The primary outcome is the dysphagia severity rating scale (DSRS), a measure of swallowing impairment, made at days 14 and 90 and analysed using repeated measures regression. Conclusion We present the statistical analysis plan for the main analyses based on data up to day 90 along with planned secondary analyses including presentation of baseline data, health economics, cognition and extended follow-up to 12 months.
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