RecruitingNot Applicable

Dysphagia, QoL and Attitudes Towards PEG in ALS Patients

Slovenia60 participantsStarted 2023-01-01

Plain-language summary

In Amyotrophic Lateral Sclerosis, dysphagia has a high incidence. With deterioration of swallowing function, percutaneous endoscopic gastrostomy (PEG) tube is recommended to ensure sufficient and safe oral intake. Dysphagia and PEG placement alter quality of life (QoL). However, QoL and attitudes toward PEG remain largely unexplored. The purpose of this study is to monitor the swallowing function in relationship to QoL and attitudes toward PEG tube insertion and feeding.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for patients: * 18 years of age or older * diagnosis of ALS * follow-up at University Medical Centre Ljubljana, Division of Neurophysiology, every 3 months * be able to visit the study site for in-person procedures every 3 months Inclusion Criteria for relatives: * at least 18 years of age Exclusion Criteria for patients: * co-existing illness or disorder that could influence the swallowing function independently of the ALS diagnosis * clinically significant cognitive deterioration or dementia at enrollment, as determined by the ALS study neurologist Exclusion criteria for relatives: * signs of probable cognitive deterioration or dementia at enrollment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Penetration-Aspiration Scale (PAS) change

Timeframe: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

Yale Residue Severity Rating Scale (YRSRS) change

Timeframe: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

Iowa Oral Performance Instrument (IOPI) change

Timeframe: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

Mann Assessment of Swallowing Ability (MASA) change

Timeframe: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

Eating Assessment Tool 10 (EAT-10) change

Timeframe: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

Swallowing Quality of Life Questionnaire (SWAL-QoL) change

Timeframe: At baseline and every 3 months until PEG insertion, 3 and 6 months after PEG insertion

Trial details

NCT IDNCT05336760

SponsorUniversity Rehabilitation Institute, Republic of Slovenia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-30

Contact for this trial

Metka Moharić, MD, PhD

+386 1 4758441 metka.moharic@ir-rs.si

View on ClinicalTrials.gov More Amyotrophic Lateral Sclerosis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Penetration-Aspiration Scale (PAS) change

Timeframe: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

Yale Residue Severity Rating Scale (YRSRS) change

Timeframe: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

Iowa Oral Performance Instrument (IOPI) change

Timeframe: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

Mann Assessment of Swallowing Ability (MASA) change

Timeframe: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

Eating Assessment Tool 10 (EAT-10) change

Timeframe: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

Swallowing Quality of Life Questionnaire (SWAL-QoL) change

Timeframe: At baseline and every 3 months until PEG insertion, 3 and 6 months after PEG insertion