Patients with ALS in the experimental, then sham arm will undergo an expiratory muscle strength training (EMST) session with a device set to 50% of patients with ALS' highest maximum expiratory pressure from their baseline pulmonary function test assessment during their first study visit. Then, during their second study visit, patients with ALS will undergo an EMST session with a device set to 0% resistance.

Patients with ALS in the sham, then experimental arm will undergo an expiratory muscle strength training (EMST) session with a device set to 0% resistance during their first study visit. Then, during their second study visit, patients with ALS will undergo an EMST session with a device set to 50% of patients with ALS' highest maximum expiratory pressure from their baseline pulmonary function test assessment.

Amyotrophic Lateral Sclerosis

Dysphagia

Dyspnea

Respiration Disorders

The experimental EMST will involve blowing into a device with a spring-loaded valve set to 50% of the patient with ALS' maximum expiratory pressure.

Experimental expiratory muscle strength training (EMST)

The sham EMST will involve blowing into a device without a spring-loaded valve (0% resistance).

Sham expiratory muscle strength training (EMST)

University of Pittsburgh Medical Center Presbyterian Hospital

Fatigue in Patients With Amyotrophic Lateral Sclerosis

Quantifying Fatigue of the Respiratory and Swallowing Musculature in Patients With Amyotrophic Lateral Sclerosis

FVC is a measure of the total amount of air that can be breathed out during a pulmonary function test to measure lung function.

PCF is a measure of air flow during a cough.

Maximum expiratory pressure is a measure of strength of the respiratory muscles when breathing out

Timing measures of physiological events that occur during swallowing based on videofluoroscopic swallow studies (measured in frames per second)

Distance measures of physiological events that occur during swallowing based on videofluoroscopic swallow studies (measured in pixels)

The MBSImP is a standardized clinical ordinal, categorical rating tool of 17 physiological components of swallowing

Feature extraction and analyses from HRCA will be completed before and after each EMST session and compared to VF to determine whether HRCA can detect fatigue related changes in swallow function.

Cara Donohue

MA CCC-SLP/PhD Student

University of Pittsburgh

This study will be a prospective study with randomized experimental and control conditions. Patients with ALS will undergo the experimental and control conditions in random order on two separate days within a two-week time frame.

During the experimental condition, expiratory muscle strength training (EMST) devices will be set to 50% of patients with ALS' highest maximum expiratory pressure from their baseline pulmonary function test assessment. During the control condition, no resistance will be added, and the loaded spring will be removed from the device. For both experimental conditions, patients with ALS will be blinded to condition.

Electronic Cigarette Use

Low strength nicotine e-liquid

High strength nicotine e-liquid

Yale University School of Medicine

Understanding Factors That Influence Electronic Cigarette Nicotine Delivery Through PET Imaging of Beta-2 Nicotinic Acetylcholine Receptors

PET Scan will be utilized to determine the brain beta-2 nicotinic acetylcholine receptor occupancy

Arterial blood nicotine levels will be measured before, during, and after e-cig use.

Yale University

National Institute on Drug Abuse (NIDA)

This group will receive access to the web-based Deprexis program, an online tool based on principles of cognitive behavioral therapy. Contents include (1) psychoeducation, (2) behavioral activation, (3) cognitive modification, (4) mindfulness and acceptance, (5) interpersonal skills, (6) relaxation, physical exercise and lifestyle modification, (7) problem solving, (8) expressive writing and forgiveness, (9) positive psychology, and (10) emotion-focused interventions.

This group will receive the web-based Deprexis program (see above) plus scheduled e-mail contact (1x/week)

Participants randomized to the control group will wait for access to the Deprexis program (waitlist control) for 6 months. After the 6-month waiting period, participants in this group will have full access to Deprexis.

Multiple Sclerosis

Online program Deprexis, either as a stand-alone internet-based intervention (Deprexis) or with added standardized email support by a clinical psychologist (DeprexisPlus). In this trial, we will use a Version of Deprexis that has been adapted to MS-specific needs.

Deprexis, DeprexisPlus

Cedars-Sinai Medical Center

University of Missouri, Kansas City

Penn State University

Charité University

Universitätsklinikum Hamburg-Eppendorf

Online Program to Reduce Depression in MS

International Deprexis Trial in Multiple Sclerosis (IDEMS) - a Multicenter Randomized Controlled Trial

4 subscales (Physical, Psychological, Social Relationships, Environmental)

Total score and 2 subscales (Motor and Cognitive)

Consists of 3 subtests. 1. SMDT (total score), CVLT-II (2 scores: learning score and delayed recall), and BVMT-R (2 scores: learning score and delayed recall)

Dichotomous variable "Major Depressive Episode, Current (yes/no)" according to module A of the MINI.

Anonymized individual data on the primary endpoint will be published alongside the trial report in a peer reviewed journal.

Friedemann Paul

Prof. Dr.

Charite University, Berlin, Germany

National Multiple Sclerosis Society

King's College London

University Medical Center Goettingen

NeuroCure Clinical Research Center, Charite, Berlin

Inspiratory muscle training with a pressure threshold device (Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA) will be start at a resistance equal to 30% of their MIP or at a load which patient can tolerate, and then the loading will be gradually increased 2cm H2O per week or as symptom tolerated and according to the RPE scale. Each patient will receive regular post-stroke rehabilitation program.

Patient will be trained daily, total 30 minutes or 15 minutes twice per day, at least 5 times a week, for 10 weeks

Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA

post-stroke rehabilitation program

Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.

Inspiratory Muscle Training in Stroke Patients With Stable Congestive Heart Failure: a Prospective RCT.

Inspiratory Muscle Training in Stroke Patients With Stable Congestive Heart Failure: a Prospective Randomized Controlled Trial.

maximal inspiratory pressure, maximal expiratory pressure MIP was measured after maximal expiration with each subject seated and wearing a nose-clip, and MEP was measured after maximal inspiration. An experienced respiratory therapist who strongly urged the subjects to make maximum inspiratory and expiratory efforts at or near residual and total lung capacity, respectively, performed the measurements. Determinations were repeated until two technically satisfactory measurements were recorded, with the highest value used for calculations.

In order to determine the best course of therapy, physicians often assess the stage of heart failure according to the (NYHA) functional classification system. This system relates symptoms to everyday activities and the patient's quality of life.

Pulmonary function tests were performed using a standard spirometer (Vitalograph, Serial Spirotrac, Buckingham, USA) according to the ATS recommendationsat the beginning and end of the 8-week home based IMT program. Measures included parameters of FVC, FEV1, and maximum mid-expiratory flow (MMEF).

The six-minute walk work (6MWORK) value was calculated as body mass x distance covered during the 6MWT.

cedrela/fatigue

Fatigue in Patients With Amyotrophic Lateral Sclerosis

Understanding Factors That Influence Electronic Cigarette Nicotine Delivery Through PET Imaging of Beta-2 Nicotinic Acetylcholine Receptors

Online Program to Reduce Depression in MS

Inspiratory Muscle Training in Stroke Patients With Stable Congestive Heart Failure: a Prospective RCT.

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