High Intensity Dysphagia Therapy for Stroke

Overseen By Alexa Taicher, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Hemorrhagic stroke, Neurological disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to help people regain their ability to swallow after a stroke. It tests a high-intensity therapy designed to improve swallowing (dysphagia) in stroke patients. The trial seeks individuals who have recently experienced an ischemic stroke (a type of stroke caused by blocked blood flow to the brain) and are having trouble swallowing. Participants should be able to follow simple instructions related to swallowing tasks. As an unphased trial, this study offers participants the chance to contribute to innovative research that could significantly enhance recovery outcomes for future stroke patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for stroke recovery?

Research has shown that high-intensity therapy for dysphagia, or trouble swallowing, can help stroke patients improve their swallowing. This treatment focuses on helping patients regain this ability.

Regarding safety, studies have not reported significant negative effects from this therapy. It is generally well-tolerated, which is important because the therapy often includes exercises to strengthen swallowing muscles.

While specific risks are not fully detailed, the absence of major side effects in past studies suggests that the therapy is likely safe for most people. Those considering joining a clinical trial for this treatment should consult their healthcare provider for advice based on their specific health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high intensity dysphagia therapy because it offers a more aggressive rehabilitation approach compared to standard speech and swallowing therapy for stroke patients. Unlike traditional methods that may involve less frequent or intense sessions, this therapy focuses on high intensity exercises aimed at rapidly improving swallowing function. This could potentially lead to quicker recovery and better outcomes for those with acute dysphagia following a stroke, providing a significant improvement in patient quality of life.

What evidence suggests that this protocol is effective for dysphagia recovery after a stroke?

Research has shown that intensive therapy can help people who have trouble swallowing after a stroke. One study found that focused care after a stroke improved swallowing within a year. This trial will evaluate high-intensity dysphagia therapy for participants with acute dysphagia during their stay in an inpatient rehab facility. Another review highlighted that recovery from swallowing difficulties improves significantly over time with proper treatment. Overall, promising evidence suggests that high-intensity therapy can benefit stroke patients with swallowing issues. ^{2 4 6 7 8}

Who Is on the Research Team?

Alba M Azola, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-99 who have had an ischemic stroke and are experiencing acute swallowing difficulties (dysphagia) as a result. Participants must be able to follow simple instructions for swallowing therapy. It's not suitable for those under 18 or over 100, with other types of strokes, previous dysphagia, or advanced progressive neurological diseases.

Inclusion Criteria

You can understand and follow simple instructions for swallowing.

I have had an ischemic stroke.

I have sudden difficulty swallowing after a stroke.

Exclusion Criteria

I have had a bleeding stroke or brain bleed.

I have a history of difficulty swallowing.

My neurological condition is getting worse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive high intensity dysphagia therapy with daily sessions including swallowing exercises and device-assisted training

6 weeks

Daily sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with a follow-up phone call

4-6 weeks post-discharge

1 follow-up call

What Are the Treatments Tested in This Trial?

Interventions

• High Intensity Dysphagia Rehab

Trial Overview The study is testing high intensity dysphagia therapy to establish a standardized treatment protocol that could improve recovery from swallowing disorders following an ischemic stroke.

How Is the Trial Designed?

Group I: Active Participants in high intensity dysphagia therapy Experimental Treatment 1 Intervention

Participants with acute dysphagia who will receive high intensity dysphagia therapy during stay in inpatient rehab facility

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11556674/

Intensified post-stroke care improves long-term dysphagia ... Intensified post-stroke care improved dysphagia recovery within 1 year after acute ischemic stroke, highlighting the potential of targeted ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05970406

High Intensity Dysphagia Rehab for Acute Ischemic Stroke ... Outcome measures will be assessed with pre and post PAS scores (comparing initial and final VFSS results), EAT 10 scores and FOIS scores as well as documented ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352013225000146

Review Predictors of recovery from dysphagia after stroke A total of 34 studies were included, involving 156,309 patients with post-stroke dysphagia, and the rate of dysphagia recovery increased from 13.53% at 1 week ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9651500/

An overview of dysphagia rehabilitation for stroke patients The results demonstrated that NMES combined with EMGBF had the potential to improve oropharyngeal swallowing in stroke patients with dysphagia.

5. withpower.com withpower.com/trial/phase-deglutition-disorders-8-2023-14406

High Intensity Dysphagia Therapy for Stroke Research shows that intensive dysphagia rehabilitation can improve swallowing function in patients with neurogenic dysphagia, which includes those with stroke- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11288910/

Prevalence, risk factors, and outcomes of dysphagia after ... Dysphagia not only increases mortality after stroke but also greatly affects the patient's quality of life, and it leads to asymmetry of the ...

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.823189/full

Post-stroke Dysphagia: Prognosis and Treatment–A ... In total, nine trials showed positive impact of the therapies on dysphagia recovery, whereas two (19, 27) did not show any difference and two ...

8. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.125.051237

Evaluating Swallowing Safety of Solid Dosage Forms Whole SDFs were not swallowed (chewed, spit out, and stopped) in 20 of the 174 trials.