Evaluating a device to improve breathing in ALS patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the impact of a mechanical insufflator-exsufflator on the respiratory function of patients with Amyotrophic Lateral Sclerosis (ALS). It focuses on measuring peak expiratory flow on cough (PEFC) to determine the effectiveness of the treatment over a four-week period. Patients will undergo three weekly sessions for two weeks, followed by daily sessions for an additional two weeks, all while receiving physiotherapy support. The study aims to provide insights into how this intervention can enhance respiratory function in ALS patients with ineffective cough.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Confirmed ALS categorized as probable or certain according to the revised Awaji-Shima criteria \[27\].
* ALS of spinal, bulbar or respiratory forms
* Peak Flow measure between 160 and 255 L/min (recommendation of MIE in case of congestion, with the possibility of daily sessions)
* Patient who has not benefited from treatment by MIE in the past year (less than 10 sessions in total)
* Patient able to use the MIE and perform the collection, or having a caregiver able to help
* Patient receiving physiotherapist treatment greater than or equal to twice a week

Exclusion Criteria:

* Psychiatric (DSM-5) or cognitive disorders incompatible with participation in the study
* Contraindication to the use of an MIE (pneumothorax for example)
* Insufficient level in French for understanding the study and completing the questionnaires
* Current or past participation in another innovative research or care program relating to respiratory functions
* Emergency situation for which the MIE must be set up within less than a week

Exclusion during the study :

* Appearance of a serious contraindication to the practice of MIE during the study (for example rib fracture during a fall)
* Patient's physiotherapist refusing to do the study

Where it's running

• SLA Center - Purpan University Hospital Toulouse, FRANCE
  Toulouse, Occitanie, France Recruiting

Study contacts

• Principal investigator: Thierry Lagarde — University Hospital, Toulouse
• Study coordinator: Thierry LAGARDE, PT
• Email: lagarde.t@chu-toulouse.fr
• Phone: +33561775570

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Implanted Brain-Computer Interface to Help People with Severe Arm Impairment

  We’re testing the N1 System, a fully implanted brain interface in the motor cortex with a robot, to see if it can help adults with spinal cord injury, ALS, or chronic stroke use a computer or keyboard more easily.

  Recruiting Neuralink Corp · Miami, Florida · NCT07929792

• Brain-computer interface chat tool for people with ALS

  This test compares a wearable brain-computer interface communication device to eye-tracking devices that people with ALS currently use to help them communicate.

  Recruiting Cognixion · Santa Barbara, California · NCT07871071

• BIIB147 safety and how it behaves in adults with ALS

  This study tests BIIB147 in adults with ALS to see if it is safe and how the body handles it, including early and long-term effects.

  Recruiting at 2 sites Phase 1/2 Biogen · St Louis, Missouri and 1 other locations · NCT07855211

• Aims to restore UNC13A function in people with ALS

  This trial tests TRCN-1023 in adults with ALS to see if it’s safe, tolerated, and shows early signs of benefit.

  Recruiting at 6 sites Phase 1/2 Trace Neuroscience, Inc. · Lübeck, Schleswig-Holstein and 5 other locations · NCT07674667

• LTX-002 in adults with ALS

  A study will test whether the experimental drug LTX-002 is safe and tolerable in adults with ALS and see how the body handles the drug and how it affects ALS indicators.

  Recruiting at 4 sites Phase 1/2 Leal Therapeutics, Inc · Lübeck and 4 other locations · NCT07660614

• Repeated ultrasound-assisted blood-brain barrier opening in ALS

  This trial tests whether repeatedly opening the blood-brain barrier with ultrasound is safe and may help people with ALS.

  Recruiting Phase 1/2 Assistance Publique - Hôpitaux de Paris · Paris · NCT07571486

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.