Dysphagia, QoL and Attitudes Towards PEG in ALS Patients

Amyotrophic Lateral Sclerosis Clinical Trial

— ALSDPEG  

Official title:

Dysphagia, Quality of Life and Attitudes Towards Percutaneous Endoscopic Gastrostomy in Patients With Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05336760
• Other study ID #: URIS202201
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: September 2023
• Source: University Rehabilitation Institute, Republic of Slovenia
• Contact: Metka Moharic, MD, PhD
• Phone: +386 1 4758441
• Email: metka.moharic[@]ir-rs.si
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The purpose of this study is to monitor the deterioration of swallowing function in ALS patient population, and to explore its impact on QoL and attitudes toward PEG tube insertion and feeding in the course of the disease. It will take maximum of 60 minutes to fully evaluate the swallowing function and complete the questionnaires. The evaluation procedure will be repeated every 3 months until PEG tube insertion, which will allow us to closely monitor the swallowing function in a relation to attitudes toward PEG and QoL. The data obtained from this study should contribute significantly to the knowledge of QoL in ALS patients with dysphagia, and it will allow for a comparison of QoL in ALS patients with and without PEG tube. This study will also expand the understanding of attitudes in ALS patients and their relatives toward PEG, and the impact of those attitudes on the decision-making process.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Diagnostic Test:
• Iowa Oral Performance Instrument (IOPI)
IOPI measures the peak pressure of the tongue strength and endurance using a disposable bulb placed on a hard palate behind the front teeth or at the base of the tongue. The participants will be asked to press the bulb with their tongue with maximum pressure, three times. To measure the endurance, the participants will be asked to hold the pressure for as long as they can.
• Mann Assessment of Swallowing Ability (MASA)
MASA is a standard clinical swallowing assessment protocol including general patient examination, on-the-outside visible signs of oral preparatory and transportation phase and pharyngeal phase of swallowing function.
• Fiberoptic Endoscopic Evaluation of Swallowing
The subjects will ingest up to 10 boluses ranging in thickness and volume (from thin to extremely-thick and a cookie).
• Respiratory function measurements
Respiratory function measurements will include forced vital capacity (FVC), maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP), all expressed in percentage of predicted values. Conventional methods of testing will be applied.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Rehabilitation Institute, Republic of Slovenia	University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penetration-Aspiration Scale (PAS) change	PAS is an 8-point scale used to determine swallowing safety. Levels 1 and 2 are considered safe, levels >3 indicate penetration or aspiration and are considered unsafe.	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Primary	Yale Residue Severity Rating Scale (YRSRS) change	YRSRS is a validated measure of swallowing efficiency using an image-based assessment to determine post-swallow pharyngeal residue: location and severity. It is assessed using a 5-point ordinal scale (from 1=0 % residue to 5=50 % residue).	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Primary	Iowa Oral Performance Instrument (IOPI) change	IOPI is a device which measures tongue strength (in kilopascals; kPa) and endurance (in seconds) while the participant presses the bulb with the front or the base of their tongue to the hard palate.	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Primary	Mann Assessment of Swallowing Ability (MASA) change	MASA is a standard clinical swallowing assessment protocol administered by the speech-language therapist. Total score ranges from 38-200. Lower score indicates higher impairment.	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Primary	Eating Assessment Tool 10 (EAT-10) change	EAT-10 is a validated self-administered dysphagia severity symptom survey including 10 items and a five-point scale (0=no problem to 4=sever problem). Higher total score indicates higher impairment.	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Primary	Swallowing Quality of Life Questionnaire (SWAL-QoL) change	SWAL-QoL is a 44-item standardised psychometric scale that measures swallowing-related QoL across 10 domains. Scores for each individual domain and a total SWAL-QoL score are calculated. Total score ranges from 0-100 (100 indicating the most favourable state).	At baseline and every 3 months until PEG insertion, 3 and 6 months after PEG insertion
Primary	Questionnaire on Attitudes Toward PEG Tube Feeding and Insertion Procedure change	The questionnaire comprises 10 questions. The participants specify their level of agreement on a five-point Likert-type scale (1=strongly disagree, 5= strongly agree).	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Secondary	ALS Functional Rating Scale-Revised (ALSFRS-R) change	ALSFRS-R is a 12-tem ALS-specific assessment of global functioning using a five-point scale (0=not able, 4= normal ability), with 48 points representing normal function.	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Secondary	Functional Oral Intake Scale (FOIS) change	FOIS is a validated 7-point scale demonstrating an individual's ability of daily oral food intake (1=no oral intake, 7=total oral intake with no restrictions).	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Secondary	Dysphagia Outcome and Severity Scale (DOSS) change	DOSS is a 7-point scale that rates the functional severity of dysphagia based on objective assessment and provides information on diet recommendations, independence level and type of nutrition necessary (level 7=normal swallowing function, level 1=severe dysphagia).	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Secondary	BMI change	Body mass index (in kg/m^2)	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Secondary	Forced Vital Capacity (FVC) change	Standard clinical respiratory assessment of FVC (in %)	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Secondary	Peak Cough Flow (PCF) change	Standard clinical respiratory assessment of PCF (in L/min)	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Secondary	Maximal Inspiratory Pressure (MIP) change	Standard clinical respiratory assessment of MIP (in cmH2)	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Secondary	Maximal Expiratory Pressure (MEP) change	Standard clinical respiratory assessment of MEP (in cmH2)	Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)