Exploratory Study on the Effects of Lung Insufflation Capacity Training Using the LIC Trainer in Patients With Amyotrophic Lateral Sclerosis: A Single-Center Prospective Interventional Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn whether lung insufflation capacity (LIC) training can help maintain respiratory function and prolong survival in people with amyotrophic lateral sclerosis (ALS). The main questions it aims to answer are: * Does early and continuous LIC training slow the decline in forced vital capacity (FVC)? * Does LIC training delay the need for tracheostomy or noninvasive ventilation (NIV)? This single-center study at the National Center of Neurology and Psychiatry (NCNP) in Japan will enroll 15 adults with ALS, diagnosed according to the El Escorial or Awaji criteria. Participants will: * Use the LIC Trainer device to perform lung insufflation training twice daily at home * Visit the clinic every 3 months for respiratory and functional assessments * Have lung tests, including FVC, LIC, maximum insufflation capacity (MIC), cough peak flow (CPF), and complete the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) There is no control group within this trial; researchers will compare results with matched historical controls from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• Age 20 years or older

• Diagnosis of amyotrophic lateral sclerosis (ALS) according to the El Escorial or Awaji criteria

• Not using noninvasive ventilation (NIV) and without tracheostomy at the start of LIC training

• Able to perform study assessments and provide written informed consent (or assisted signature with communication aid)

Locations
Other Locations
Japan
National Center of Neurology and Psychiatry (NCNP)
RECRUITING
Kodaira
Contact Information
Primary
Study Office
rinri-jimu@ncnp.go.jp
+81-42-341-2712
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2030-03-31
Participants
Target number of participants: 15
Treatments
Experimental: LIC Training
Participants with amyotrophic lateral sclerosis (ALS) will perform lung insufflation capacity (LIC) training using the LIC Trainer device to maintain lung and chest wall compliance. Each session consists of about 10 assisted insufflations performed twice daily at home. Physical therapists provide initial instruction and re-evaluation every 3 months during the 36-month follow-up period. The intervention aims to preserve pulmonary function, reduce respiratory complications, and prolong survival.
Sponsors
Leads: National Center of Neurology and Psychiatry, Japan

This content was sourced from clinicaltrials.gov