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Procedure

Mechanical Insufflation for ALS (MI-PALS Trial)

N/A
Recruiting
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
No Placebo-Only Group

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 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,079 Previous Clinical Trials
42,721,601 Total Patients Enrolled
Jason Ackrivo, MDPrincipal InvestigatorUniversity of Pennsylvania
~13 spots leftby Sep 2025
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