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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

MI-PALS Trial 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.Check my eligibility

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.See study design

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.

MI-PALS Trial 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.

MI-PALS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

peak cough flow (PCF)

Secondary outcome measures

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 outcome measures

Time to start of non-invasive ventilation

Tracheostomy free survival time

MI-PALS 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,068 Total Patients Enrolled

Jason Ackrivo, MDPrincipal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any openings for participants in this study?

"Unfortunately, according to the details found on clinicaltrials.gov, this study is no longer recruiting patients. It was initially posted in March of 2024 and last updated in October of 2023. However, there are currently 731 other medical trials actively looking for participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study

2024. "Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06119087.

All > Lou Gehrigs Disease > Als