Amyotrophic Lateral SclerosisEarly Phase 1NCT02710110
Respiratory Strength Training in Persons With Amyotrophic Lateral Sclerosis (ALS)
A Early Phase 1 study testing PowerLung trainer, Micro Mouth Pressure Meter and Pulmonary Function Testing in people with Amyotrophic Lateral Sclerosis, run by University of Florida at 1 site in United States.
Trial summary
Dysphagia (swallow impairment), dystussia (cough impairment) and respiratory impairment are hallmark features of amyotrophic lateral sclerosis (ALS). These symptoms are the cause of fatal aspiration, malnutrition and respiratory insufficiency that together account for 91.4% of ALS mortality. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- PowerLung trainer, Micro Mouth Pressure Meter and Pulmonary Function Testing
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 7 Feb 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of probable or definite Amyotrophic Lateral Sclerosis (ALS),
- Amyotrophic Lateral Sclerosis Rating Scale Revised score greater than 34,
- forced vital capacity greater than 70%,
- cognition within normal limits as determined by Montreal assessment of cognition score >25
Who cannot join
- allergies to barium,
- tracheotomy or mechanical ventilation,
- diaphragmatic pacer,
- concurrent respiratory disease (e.g. COPD),
- pregnant at the time of the study due to radiation exposure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Respiratory Strength Training in Individuals With Amyotrophic Lateral Sclerosis (ALS)
Dysphagia (swallow impairment), dystussia (cough impairment) and respiratory impairment are hallmark features of amyotrophic lateral sclerosis (ALS). These symptoms are the cause of fatal aspiration, malnutrition and respiratory insufficiency that together account for 91.4% of ALS mortality. Unfortunately, treatments to prolong and maintain these vital functions are currently lacking. Although the use of exercise in ALS is controversial, recent evidence suggests that mild to moderate intensity exercise applied early in the disease slows disease progression, improves motor function, preserves motor neuron number, reduces muscle hypoplasia, atrophy astrogliosis, and prolongs survival in animal models of ALS and human clinical trials.
This research study is designed to determine the impact of respiratory strength training on breathing, airway protection and swallowing in persons with Amyotrophic Lateral Sclerosis (ALS).
Read the detailed description
This research study will measure the maximum inspiratory and expiratory pressure with secondary measures of respiration, swallow, cough, quality of life and global disease progression following twelve-weeks of treatment compared to the sham group.
As a participant two evaluations at the University of Florida Swallowing Systems Core laboratory located at Shands Hospital, Gainesville will take place. Each will take approximately two-hours and these will be spaced exactly three-months apart. During each evaluation tests will be performed to look at breathing, swallowing, and ability to cough doing standard clinical exams. In addition, some surveys about eating, speaking and quality of life will be taken.
Breathing Exercises: a home research therapist will train the participants how to use the hand-held respiratory trainer. Training for both treatment groups will be very similar, except the PowerLung trainer device will have an additional spring load valve inside it that will place a force on the respiratory muscles during training. The other breathing trainer will not have this spring so that no resistance will be placed on the respiratory muscles during training and this will represent an aerobic respiratory treatment. The breathing exercises will be completed five days a week for a total of three months (a total of 60 therapy sessions). During each session, a total of three sets of ten repetitions of breathing exercises will be performed. Once a week the home research therapist will visit and guide participants through the breathing exercise.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- PowerLung trainer, Micro Mouth Pressure Meter, Pulmonary Function Testing, Videofluoroscopic swallowing study, Swallowing Quality of Life Questionnaire
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PowerLung trainerDevice
PowerLung trainer will be utilized which has both an inspiratory and expiratory loading capacity for training. A single daily training session will consist of three sets of 10 repetitions for a total of 30 inspiratory repetitions and 30 expiratory repetitions (i.e. 60 repetitions) for 5 days a week, for 3 months.
Micro Mouth Pressure MeterDevice
Also called digital manometer, Micro Medical device
The participant will be seated with the nose occluded using a nose clip. After inhaling to total lung capacity, the participant will place his or her lips around the mouthpiece and blow out as forcefully as possible. A flange rubber mouthpiece will be used to overcome the inability of some individuals to create tight lip seal due to facial muscle weakness. Three trials will be performed and the patients highest Maximum Inspiratory Pressures (MIP) and Maximal Expiratory Pressure (MEP) used.
Pulmonary Function TestingProcedure or surgery
Pulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), sniff nasal inspiratory pressure (SNIP), peak expiratory flow (PEF), forced expiratory volume (FEV1) expressed as a percentage of predicted values.
Videofluoroscopic swallowing studyProcedure or surgery
Also called VFSS, X-ray of swallowing
Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.
Swallowing Quality of Life QuestionnaireOther
Also called SWAL-QOL
Swallowing Quality of Life Questionnaire (SWAL-QOL) will be used for participant reporting of swallow-related quality of life.
Iowa Oral Pressure InstrumentDevice
Also called IOPI
The IOPI is a device that measures the peak pressure performance of lingual strength and endurance via the action of a bulb placed on the hard palate.
CapsaicinDrug
Also called Hot pepper
A capsaicin challenge with three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin. The capsaicin will be dissolved in a vehicle solution consisting of 80% physiological saline, and 20% ethanol. Participants will be given the instruction "cough if you need to" prior to capsaicin delivery.The solution will be administered automatically upon detection of an inspired breath and there will be a minimum of one minute between each trial. This is to test the reflexive cough testing for upper airway sensitivity and motor thresholds.
| Study group | Role | What they receive |
|---|---|---|
| Active Respiratory Trainer | Experimental | Participants enrolled in this arm will be given the PowerLung trainer. The adjustable spring allows for discrete and calibrated changes to the valve, which in turn blocks air until sufficient inspiratory or expiratory pressure is applied by an individual. In addition, the Micro Mouth Pressure Meter, Pulmonary Function testing, videofluoroscopic swallowing study (VFSS), Swallowing Quality of Life Questionnaire (SWAL-QOL), Iowa Oral Pressure Instrument (IOPI), and capsaicin for use in the reflexive cough test. Receives: Device: PowerLung trainer; Device: Micro Mouth Pressure Meter; Procedure: Pulmonary Function Testing; Procedure: Videofluoroscopic swallowing study; Other: Swallowing Quality of Life Questionnaire; Device: Iowa Oral Pressure Instrument; Drug: Capsaicin |
| Sham Trainer | Sham comparator | Participants enrolled in this arm will be given the PowerLung trainer; however, the adjustable spring allows for discrete and calibrated changes to the valve and these will not have any resistance. In addition, the Micro Mouth Pressure Meter, Pulmonary Function testing, videofluoroscopic swallowing study (VFSS), Swallowing Quality of Life Questionnaire (SWAL-QOL), Iowa Oral Pressure Instrument (IOPI), and capsaicin for use in the reflexive cough test. Receives: Device: PowerLung trainer; Device: Micro Mouth Pressure Meter; Procedure: Pulmonary Function Testing; Procedure: Videofluoroscopic swallowing study; Other: Swallowing Quality of Life Questionnaire; Device: Iowa Oral Pressure Instrument; Drug: Capsaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Expiratory Pressure will be measured between the groups for a change from baseline to month 3
Maximum expiratory pressure is a measure of force generating capabilities as assessed by having subjects quickly inhale then rapidly blow out air into a handheld manometer (Micro Mouth Pressure Meter). Three trails will be performed and the highest will be used.
Measured: Changes from baseline to month 3
Maximum Inspiratory Pressure will be measured between the groups for a change from baseline to month 3
Maximum inspiratory pressure is a measure of force generating capabilities as assessed by having subjects quickly inhale then rapidly blow out air into a handheld manometer (Micro Mouth Pressure Meter). Three trails will be performed and the highest will be used.
Measured: Changes from baseline to month 3
Pulmonary function to measure the forced vital capacity (FVC) between the groups for a change from baseline to month 3
Pulmonary Function testing will be performed using a micro pressure meter. The participant will perform a maximum inhalation and then slowly blow out air into the mouthpiece of the meter. The following measurement will be displayed on the meter after the exhalation is complete forced vital capacity (FVC) expressed as a percentage of predicted values.
Measured: Changes from baseline to month 3
Sniff Nasal Inspiratory Pressure will be measured between the groups for a change from baseline to month 3
Measured: Changes from baseline to month 3
Pulmonary function to measure the peak expiratory flow (PEF) will be measured between the groups for a change from baseline to month 3
Pulmonary Function testing will be performed using a micro pressure meter. The participant will perform a maximum inhalation and then slowly blow out air into the mouthpiece of the meter. The following measurement will be displayed on the meter after the exhalation is complete peak expiratory flow (PEF) expressed as a percentage of predicted values.
Measured: Changes from baseline to month 3
Pulmonary function to measure the forced expiratory volume (FEV1) will be measured between the groups for a change from baseline to month 3
Pulmonary Function testing will be performed using a micro pressure meter. The participant will perform a maximum inhalation and then slowly blow out air into the mouthpiece of the meter. The following measurement will be displayed on the meter after the exhalation is complete forced expiratory volume (FEV1) expressed as a percentage of predicted values.
Measured: Changes from baseline to month 3
Secondary outcomes (5)
The Penetration-aspiration scale will be used to measure swallowing function
Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.
Measured: Changes from baseline to month 3
Lingual strength will be measured between the groups for a change from baseline to month 3
The Iowa Oral Pressure Instrument device will measure the peak performance of lingual strength a via the action of a bulb placed on the hard palate. To assess maximum anterior isometric pressure, the bulb will be placed on the roof of the mouth and the participant will raise his or her tongue to apply pressure to this bulb and then quickly release the tongue back into a neutral position. This repetitive tongue movement will be performed three times and values will be recorded.
Measured: Changes from baseline to month 3
Lingual endurance will be measured between the groups for a change from baseline to month 3
The Iowa Oral Pressure Instrument device will measure the peak performance of maximum lingual endurance time by instructing the participant to place the bulb on the roof of the mouth and then apply and sustain pressure to the bulb for as long as he/she can at a threshold of 20% of the maximum anterior isometric pressure. The maximum lingual endurance time will also be recorded.
Measured: Changes from baseline to month 3
Voluntary cough function will be measured between the groups for a change from baseline to month 3
Voluntary cough function will be assessed using an oral pneumotachograph, connected to a spirometer filter during voluntary cough production. The participant will be seated with a respiratory face-mask held in place by the examiner and instructed to complete three tidal breaths into the face-mask, airflow signal will be measured
Measured: Changes from baseline to month 3
Reflexive cough will be measured between the groups for a change from baseline to month 3
Reflexive cough will be assessed using an oral pneumotachograph, differential pressure transducer, and have a side port with a one-way inspiratory valve for nebulizer connection. The nebulizer will deliver three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin.
Measured: Changes from baseline to month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startApr 2016
- Primary completion30 Nov 2017
- Study completion7 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- ALS Association
- Responsible party
- Sponsor
- Investigators
- Emily K Plowman, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710110
- Sponsor's protocol ID
- IRB201501172
- Status last verified
- Jan 2020
- First submitted
- 26 Feb 2016
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Respiratory Strength Training in Individuals With Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT02710110
- Acronym / sponsor ID
- IRB201501172
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- ALS Association
- Study start
- Apr 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dysphagia (swallow impairment), dystussia (cough impairment) and respiratory impairment are hallmark features of amyotrophic lateral sclerosis (ALS). These symptoms are the cause of fatal aspiration, malnutrition and respiratory insufficiency that together account for 91.4% of ALS mortality. Unfortunately, treatments to prolong and maintain these vital functions are currently lacking. Although the use of exercise in ALS is controversial, recent evidence suggests that mild to moderate intensity exercise applied early in the disease slows disease progression, improves motor function, preserves motor neuron number, reduces muscle hypoplasia, atrophy astrogliosis, and prolongs survival in animal models of ALS and human clinical trials.
This research study is designed to determine the impact of respiratory strength training on breathing, airway protection and swallowing in persons with Amyotrophic Lateral Sclerosis (ALS).
Detailed description
This research study will measure the maximum inspiratory and expiratory pressure with secondary measures of respiration, swallow, cough, quality of life and global disease progression following twelve-weeks of treatment compared to the sham group.
As a participant two evaluations at the University of Florida Swallowing Systems Core laboratory located at Shands Hospital, Gainesville will take place. Each will take approximately two-hours and these will be spaced exactly three-months apart. During each evaluation tests will be performed to look at breathing, swallowing, and ability to cough doing standard clinical exams. In addition, some surveys about eating, speaking and quality of life will be taken.
Breathing Exercises: a home research therapist will train the participants how to use the hand-held respiratory trainer. Training for both treatment groups will be very similar, except the PowerLung trainer device will have an additional spring load valve inside it that will place a force on the respiratory muscles during training. The other breathing trainer will not have this spring so that no resistance will be placed on the respiratory muscles during training and this will represent an aerobic respiratory treatment. The breathing exercises will be completed five days a week for a total of three months (a total of 60 therapy sessions). During each session, a total of three sets of ten repetitions of breathing exercises will be performed. Once a week the home research therapist will visit and guide participants through the breathing exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Respiratory Trainer | Experimental | Device: PowerLung trainer, Device: Micro Mouth Pressure Meter, Procedure: Pulmonary Function Testing, Procedure: Videofluoroscopic swallowing study, Other: Swallowing Quality of Life Questionnaire, Device: Iowa Oral Pressure Instrument, Drug: CapsaicinParticipants enrolled in this arm will be given the PowerLung trainer. The adjustable spring allows for discrete and calibrated changes to the valve, which in turn blocks air until sufficient inspiratory or expiratory pressure is applied by an individual. In addition, the Micro Mouth Pressure Meter, Pulmonary Function testing, videofluoroscopic swallowing study (VFSS), Swallowing Quality of Life Questionnaire (SWAL-QOL), Iowa Oral Pressure Instrument (IOPI), and capsaicin for use in the reflexive cough test. |
| Sham Trainer | Sham comparator | Device: PowerLung trainer, Device: Micro Mouth Pressure Meter, Procedure: Pulmonary Function Testing, Procedure: Videofluoroscopic swallowing study, Other: Swallowing Quality of Life Questionnaire, Device: Iowa Oral Pressure Instrument, Drug: CapsaicinParticipants enrolled in this arm will be given the PowerLung trainer; however, the adjustable spring allows for discrete and calibrated changes to the valve and these will not have any resistance. In addition, the Micro Mouth Pressure Meter, Pulmonary Function testing, videofluoroscopic swallowing study (VFSS), Swallowing Quality of Life Questionnaire (SWAL-QOL), Iowa Oral Pressure Instrument (IOPI), and capsaicin for use in the reflexive cough test. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of probable or definite Amyotrophic Lateral Sclerosis (ALS),
- Amyotrophic Lateral Sclerosis Rating Scale Revised score greater than 34,
- forced vital capacity greater than 70%,
- cognition within normal limits as determined by Montreal assessment of cognition score >25
Key exclusion criteria (5 listed)
- allergies to barium,
- tracheotomy or mechanical ventilation,
- diaphragmatic pacer,
- concurrent respiratory disease (e.g. COPD),
- pregnant at the time of the study due to radiation exposure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PowerLung trainerPowerLung trainer will be utilized which has both an inspiratory and expiratory loading capacity for training. A single daily training session will consist of three sets of 10 repetitions for a total of 30 inspiratory repetitions and 30 expiratory repetitions (i.e. 60 repetitions) for 5 days a week, for 3 months. | Device | Active Respiratory Trainer, Sham Trainer |
| Micro Mouth Pressure MeterAlso: digital manometer, Micro Medical deviceThe participant will be seated with the nose occluded using a nose clip. After inhaling to total lung capacity, the participant will place his or her lips around the mouthpiece and blow out as forcefully as possible. A flange rubber mouthpiece will be used to overcome the inability of some individuals to create tight lip seal due to facial muscle weakness. Three trials will be performed and the patients highest Maximum Inspiratory Pressures (MIP) and Maximal Expiratory Pressure (MEP) used. | Device | Active Respiratory Trainer, Sham Trainer |
| Pulmonary Function TestingPulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), sniff nasal inspiratory pressure (SNIP), peak expiratory flow (PEF), forced expiratory volume (FEV1) expressed as a percentage of predicted values. | Procedure or surgery | Active Respiratory Trainer, Sham Trainer |
| Videofluoroscopic swallowing studyAlso: VFSS, X-ray of swallowingVideofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing. | Procedure or surgery | Active Respiratory Trainer, Sham Trainer |
| Swallowing Quality of Life QuestionnaireAlso: SWAL-QOLSwallowing Quality of Life Questionnaire (SWAL-QOL) will be used for participant reporting of swallow-related quality of life. | Other | Active Respiratory Trainer, Sham Trainer |
| Iowa Oral Pressure InstrumentAlso: IOPIThe IOPI is a device that measures the peak pressure performance of lingual strength and endurance via the action of a bulb placed on the hard palate. | Device | Active Respiratory Trainer, Sham Trainer |
| CapsaicinAlso: Hot pepperA capsaicin challenge with three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin. The capsaicin will be dissolved in a vehicle solution consisting of 80% physiological saline, and 20% ethanol. Participants will be given the instruction "cough if you need to" prior to capsaicin delivery.The solution will be administered automatically upon detection of an inspired breath and there will be a minimum of one minute between each trial. This is to test the reflexive cough testing for upper airway sensitivity and motor thresholds. | Drug | Active Respiratory Trainer, Sham Trainer |
Primary outcome
Maximum Expiratory Pressure will be measured between the groups for a change from baseline to month 3
Time frame: Changes from baseline to month 3
Maximum expiratory pressure is a measure of force generating capabilities as assessed by having subjects quickly inhale then rapidly blow out air into a handheld manometer (Micro Mouth Pressure Meter). Three trails will be performed and the highest will be used.
Maximum Inspiratory Pressure will be measured between the groups for a change from baseline to month 3
Time frame: Changes from baseline to month 3
Maximum inspiratory pressure is a measure of force generating capabilities as assessed by having subjects quickly inhale then rapidly blow out air into a handheld manometer (Micro Mouth Pressure Meter). Three trails will be performed and the highest will be used.
Pulmonary function to measure the forced vital capacity (FVC) between the groups for a change from baseline to month 3
Time frame: Changes from baseline to month 3
Pulmonary Function testing will be performed using a micro pressure meter. The participant will perform a maximum inhalation and then slowly blow out air into the mouthpiece of the meter. The following measurement will be displayed on the meter after the exhalation is complete forced vital capacity (FVC) expressed as a percentage of predicted values.
Sniff Nasal Inspiratory Pressure will be measured between the groups for a change from baseline to month 3
Time frame: Changes from baseline to month 3
Pulmonary function to measure the peak expiratory flow (PEF) will be measured between the groups for a change from baseline to month 3
Time frame: Changes from baseline to month 3
Pulmonary Function testing will be performed using a micro pressure meter. The participant will perform a maximum inhalation and then slowly blow out air into the mouthpiece of the meter. The following measurement will be displayed on the meter after the exhalation is complete peak expiratory flow (PEF) expressed as a percentage of predicted values.
Pulmonary function to measure the forced expiratory volume (FEV1) will be measured between the groups for a change from baseline to month 3
Time frame: Changes from baseline to month 3
Pulmonary Function testing will be performed using a micro pressure meter. The participant will perform a maximum inhalation and then slowly blow out air into the mouthpiece of the meter. The following measurement will be displayed on the meter after the exhalation is complete forced expiratory volume (FEV1) expressed as a percentage of predicted values.
5 secondary outcomes
The Penetration-aspiration scale will be used to measure swallowing function
Time frame: Changes from baseline to month 3
Lingual strength will be measured between the groups for a change from baseline to month 3
Time frame: Changes from baseline to month 3
Lingual endurance will be measured between the groups for a change from baseline to month 3
Time frame: Changes from baseline to month 3
Voluntary cough function will be measured between the groups for a change from baseline to month 3
Time frame: Changes from baseline to month 3
Reflexive cough will be measured between the groups for a change from baseline to month 3
Time frame: Changes from baseline to month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily K Plowman, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PowerLung trainer, Micro Mouth Pressure Meter and Pulmonary Function Testing in people with Amyotrophic Lateral Sclerosis, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Expiratory Pressure will be measured between the groups for a change from baseline to month 3 (time frame: Changes from baseline to month 3). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.