Amyotrophic Lateral Sclerosis Non-invasive Ventilation Exchange

NCT05837507 | Unknown

• 1 other identifier: RECHMPL23_0054
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

The median survival of patients with amyotrophic lateral sclerosis (ALS) is 3 to 5 years and mortality is mainly related to respiratory failure. Non-invasive ventilation (NIV) and multidisciplinary management improve the quality of life and survival of patients. However, patients have mobility difficulties related to the progressive worsening of functional disabilities. The research team hypothesize that the use of a multimodal digital platform, including in particular telemonitoring of NIV and teleconsultation, will slow down the evolution of the disabilities of patients with ALS and improve their quality of life.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic lateral sclerosis (ALS); Non invasive ventilation; Telemonitoring; Telemedicine; Multidisciplinary approach

Outcome Measures

Primary Outcomes (1)

• Difference in change in functional abilities between the experimental and control groups over 6 months of follow-up.

  Difference in variation of the functional capabilities assessed by the Amyotrophic lateral sclerosis functional rating scale (ALSFRS) score at Baseline (D0) and 6 months between the experimental group and the control group. A scale to determine different aspects of functionality in patients with ALS, minimum 0 points, maximum 48 points, derived from a questionnaire with 12 questions, each of which can yield up to 4 points, higher score indicates better functionality

  Between baseline and 6 months

Secondary Outcomes (35)

• Difference in change in functional abilities between the experimental and control groups during 3 months of follow-up (Between 3 months and 6 months).

  Between 3 months and 6 months

• Difference in change in functional abilities between the experimental and control groups during 3 months of follow-up (Between Baseline and 3 months).

  Between Baseline and 3 months

• Evolution of dyspnea between the 2 groups between baseline and 3 months

  Between Baseline and 3 months

• Evolution of dyspnea between the 2 groups between baseline and 6 months

  Between Baseline and 6 months

• Evolution of Quality of life between the 2 groups between baseline and 3 months

  Between Baseline and 3 months

Study Arms (2)

Experimental

EXPERIMENTAL

A group of 29 patients with ALS will be formed to the multimodal digital platform associated with Non Invasive Ventilation (NIV) and usual management Patients will be treated with NIV equipment from the manufacturer LOWENSTEIN and will benefit from the usual follow-up carried out at the reference center of Montpellier University Hospital.

Other: Telerehabilitation solution (m-Rehab); Other: Usual management including NIV.

Control Comparator

ACTIVE COMPARATOR

A group of 29 patients with ALS will be formed : control group following usual management including NIV. Patients will be treated with NIV equipment from the manufacturer LOWENSTEIN and will benefit from the usual follow-up carried out at the reference center of Montpellier University Hospital.

Other: Usual management including NIV.

Interventions

Telerehabilitation solution (m-Rehab) OTHER

Patients in the experimental group will have access to a multimodal digital platform (m-Rehab®). The solution includes a website and an application available on smart phones for the patient and caregivers. Patients and caregivers will have access to educational content about the condition and its treatments, NIV compliance data, digital group educational workshops, secure messaging and video conferencing. All the professionals forming the patient's circle of care will be able to have access to the solution, after the patient's authorization. The circle of care, in a non-exhaustive way, includes specialist doctors, the general practitioner, the staff of the reference center of the Montpellier University Hospital, the physiotherapist, the speech therapist, the dietician and the psychologist.

Experimental

Usual management including NIV. OTHER

Usual management including NIV.

Control Comparator; Experimental

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 30 and 85 years old
• Diagnosis of ALS
• Indication and acceptance of non-invasive ventilation
• Patient equipped with suitable equipment (tablet, computer, telephone, etc.) with an internet connection at home
• Patient able to read and understand the procedure, and able to express consent for the study protocol

You may not qualify if:

• Treatment with non-invasive ventilation in the previous three months
• Refusal/inability to use a smart phone or digital device
• Subject under guardianship or curators
• Subject not affiliated to a social security scheme, or not a beneficiary of such a scheme.
• Subject deprived of liberty by judicial or administrative decision
• Pregnant, parturient, breastfeeding women
• Refusal to give consent

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Université Montpellier: collaborator

Study Sites (2)

Uh Montpellier

Montpellier, 34295, France

RECRUITING

Clinique du Millénaire

Montpellier, 34960, France

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Francois BUGHIN, MD

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Francois BUGHIN, MD

CONTACT

04.67.33.82.84; f-bughin@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, two-armed, interventional controlled study versus multicenter, open-label study.

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: July 5, 2023
• Primary Completion: November 1, 2024
• Study Completion: May 1, 2025
• Last Updated: July 11, 2023

Record last verified: 2023-04

Locations

FR (2)