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Procedure

Mechanical Insufflation for ALS (MI-PALS Trial)

N/A

Waitlist Available

Led By Jason Ackrivo, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an able and willing caregiver to assist with mechanical insufflation on a daily basis

Age ≥18 years

Must not have

Medical history of chronic obstructive pulmonary disease

Medical history of right heart failure or pulmonary hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Summary

This trial will study how using a device to mechanically insufflate & exsufflate affects breathing in early ALS. It will compare results of 20 patients using the device to 20 who don't.

Who is the study for?

This trial is for adults over 18 with early-stage amyotrophic lateral sclerosis (ALS) who have a caregiver to help them. Participants must be non-smokers, not using mechanical insufflation-exsufflation (MI-E), and without certain respiratory or heart conditions. Pregnant individuals or those on specific ventilation treatments are excluded.

What is being tested?

The study tests the effects of mechanical insufflation using the BiWaze Cough system on breathing in ALS patients. It's a single-arm study comparing peak cough flow in participants using MI daily against those who do not use it.

What are the potential side effects?

Potential side effects may include discomfort from device use, possible lung irritation, and risks associated with pressure changes such as pneumothorax (collapsed lung) or barotrauma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have someone to help me with my daily medical device use.

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I am 18 years old or older.

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I have been diagnosed with ALS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of chronic obstructive pulmonary disease.

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I have a history of right heart failure or high blood pressure in the lungs.

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I have recently coughed up blood.

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I am under 18 years old.

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I cannot perform lung function tests like coughing or breathing into a machine.

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I have a history or risk of air leaking into the space around my lungs.

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I have a history or risk of collapsed lung.

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I have recently experienced pressure-related ear or lung injury.

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I have a history of emphysema.

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I am currently using a Bi-PAP machine or my doctor has prescribed one for me today.

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I have heart failure with a heart pumping efficiency of less than 50%.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

peak cough flow (PCF)

Secondary study objectives

ALS Functional Rating Scale - Revised (ALSFRS-R) dyspnea and orthopnea scores

Forced vital capacity (FVC)

Global rate of change score for peak cough flow

+6 more

Other study objectives

Time to start of non-invasive ventilation

Tracheostomy free survival time

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mechanical insufflationExperimental Treatment1 Intervention

Participants will be asked to perform mechanical insufflation using the BiWaze cough device as 5 sets of 5 insufflations twice daily for 6 months.

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,053 Previous Clinical Trials

43,013,107 Total Patients Enrolled

Jason Ackrivo, MDPrincipal InvestigatorUniversity of Pennsylvania

~13 spots leftby Sep 2025

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