Amyotrophic Lateral Sclerosis (ALS)NCT07844590
Developing New Ways to Detect Respiratory Impairment Early in ALS
An observational study of Amyotrophic Lateral Sclerosis (ALS), run by Thomas Jefferson University at 1 site in United States.
Trial summary
The goal of this observational study is to develop new ways to detect early changes associated with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The study will examine whether changes in breathing, magnetic resonance imaging (MRI) of the brainstem and spinal cord, and blood markers can… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include adults with symptomatic ALS, asymptomatic or presymptomatic individuals with genetic variants associated with ALS, and healthy age- and sex-matched controls. Participants with ALS or genetic risk for ALS will be recruited from Thomas Jefferson University and other ALS patient inventories and referral sources.
Who may be able to join
- Symptomatic participants with ALS must have an ALS Functional Rating Scale-Revised (ALSFRS-R) score of 47/48 or less at the time of recruitment.
- Asymptomatic/presymptomatic participants must have a pathogenic C9orf72 expansion of at least 25 repeats or a similar genetic abnormality known to be associated with ALS.
- Healthy control participants must have no clinically identifiable neurological deficits based on medical history and screening. -
Who cannot join
- Any safety concern or contraindication to MRI based on MRI safety screening.
- Healthy control participants who do not pass the neurological screening.
- Pregnancy.
- Metal implants above the waist, including cardiac pacemakers or brain, neck, cervical, or thoracic implants.
- Neurocognitive impairment.
- Inability or unwillingness to provide informed consent.
- Younger than 18 years of age.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University - Center City
Philadelphia, Pennsylvania, 19107
Dana Johnson, DPT, 215-326-9153, Dana.Johnson@jefferson.edu
Jayakrishnan Nair, PhD, PT, 352-871-5888, Jayakrishnan.Nair@jefferson.edu
About this study
Official title: Early Detection of Respiratory Impairments in ALS: A Novel Diagnostic Approach
The goal of this observational study is to develop new ways to detect early changes associated with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The study will examine whether changes in breathing, magnetic resonance imaging (MRI) of the brainstem and spinal cord, and blood markers can identify early signs of ALS before major physical changes occur.
The main questions the study aims to answer are:
Read more
- Can changes in automatic breathing help identify early ALS-related changes?
- Can breathing measures distinguish people with ALS from people without ALS?
- Do people with genetic risk for ALS who show changes in breathing also have changes in the brainstem and spinal cord or higher levels of blood markers associated with nerve damage?
Participants will complete breathing and muscle function tests, an MRI scan of the brainstem and spinal cord, and blood testing. The study will include people with ALS, people with genetic risk for ALS who do not yet have symptoms, and healthy adults for comparison.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- Amyotrophic lateral sclerosis, Early diagnosis, Respiratory function, Respiratory impairment, Respiratory biomarkers, Biomarkers, Neuroimaging, Magnetic resonance imaging, Brainstem, Spinal cord, Neurofilament light chain, Genetic risk, Presymptomatic amyotrophic lateral sclerosis, Motor neuron disease, Respiratory muscle function, Lou Gehrig's disease, automatic breathing, respiratory control, respiratory weakness, respiratory muscle strength
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Disease, Respiratory Aspiration, Respiratory Insufficiency, Charcot-Marie-Tooth disease, Type 1F, Motor Neuron Disease, Hypoxia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic Amyotrophic Lateral Sclerosis | Participants with symptomatic amyotrophic lateral sclerosis (ALS), including familial or sporadic ALS, who have clinical evidence of disease. This group will undergo study assessments to characterize respiratory function and biomarkers associated with ALS. | |
| Asymptomatic/Presymptomatic ALS Gene Carriers | Participants who carry a genetic variant associated with amyotrophic lateral sclerosis but do not have clinical symptoms or functional deficits associated with ALS. This group will be evaluated for early or subclinical changes in respiratory function and other biomarkers associated with ALS. | |
| Healthy Controls | Neurologically healthy participants without clinically identifiable neurological deficits who will serve as a comparison group for the study assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of the Automatic Breathing Impairment Risk Score (P0.1 + Chemosensitivity) for Detecting ALS-Related Respiratory Dysfunction
A linear prediction risk score combining airway occlusion pressure at 0.1 seconds (P0.1) and chemosensitivity will be developed to distinguish symptomatic ALS participants with respiratory dysfunction from healthy controls. Diagnostic performance of the risk score will be evaluated using the area under the receiver operating characteristic curve (ROC-AUC), and an optimal cutoff will be determined. The resulting cutoff will subsequently be used to identify subclinical respiratory impairment in asymptomatic/presymptomatic ALS gene carriers.
Measured: During the single study visit
Secondary outcomes (6)
Fractional Anisotropy of the Brainstem and Cervical Spinal Cord
Fractional anisotropy (FA) will be derived from diffusion tensor imaging of the brainstem and cervical spinal cord to evaluate microstructural abnormalities associated with ALS. FA will be compared among healthy controls and asymptomatic/presymptomatic ALS gene carriers who test positive or negative for automatic breathing impairment.
Measured: During the single study visit
Axial Diffusivity of the Brainstem and Cervical Spinal Cord
Axial diffusivity will be derived from diffusion tensor imaging of the brainstem and cervical spinal cord to evaluate microstructural abnormalities associated with ALS. Measurements will be compared among healthy controls and asymptomatic/presymptomatic ALS gene carriers who test positive or negative for automatic breathing impairment.
Measured: During the single study visit
Radial Diffusivity of the Brainstem and Cervical Spinal Cord
Radial diffusivity will be derived from diffusion tensor imaging of the brainstem and cervical spinal cord to evaluate microstructural abnormalities associated with ALS. Measurements will be compared among healthy controls and asymptomatic/presymptomatic ALS gene carriers who test positive or negative for automatic breathing impairment.
Measured: During the single study visit
Mean Diffusivity of the Brainstem and Cervical Spinal Cord
Mean diffusivity will be derived from diffusion tensor imaging of the brainstem and cervical spinal cord to evaluate microstructural abnormalities associated with ALS. Measurements will be compared among healthy controls and asymptomatic/presymptomatic ALS gene carriers who test positive or negative for automatic breathing impairment.
Measured: During the single study visit
Plasma Neurofilament Light Chain (Nf-L) Level
Neurofilament light chain (Nf-L) levels in plasma will be measured as a blood-based marker of neurodegeneration. Plasma Nf-L levels will be compared among healthy controls and asymptomatic/presymptomatic ALS gene carriers who test positive or negative for automatic breathing impairment to determine whether respiratory impairment is associated with greater evidence of neurodegeneration.
Measured: During the single study visit
Serum Neurofilament Light Chain (Nf-L) Level
Neurofilament light chain (Nf-L) levels in serum will be measured as a blood-based marker of neurodegeneration. Serum Nf-L levels will be evaluated in relation to automatic breathing impairment and compared across study groups as an additional blood-based biomarker of ALS-related neurodegeneration.
Measured: During the single study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study startSep 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (59)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Jayakrishnan Nair, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844590
- Sponsor's protocol ID
- 22D.834
- Other IDs
- 1R21NS145175-01A1
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in study publications will be shared. Data may include demographic and clinical data, functional respiratory measurements, brainstem and spinal cord MRI data, and blood biomarker data, including neurofilament light chain measurements. Data will be shared without direct participant identifiers and in accordance with applicable data use agreements and institutional requirements.
Publications
Raz E, Bester M, Sigmund EE, Tabesh A, Babb JS, Jaggi H, Helpern J, Mitnick RJ, Inglese M. A better characterization of spinal cord damage in multiple sclerosis: a diffusional kurtosis imaging study. AJNR Am J Neuroradiol. 2013 Sep;34(9):1846-52. doi: 10.3174/ajnr.A3512. Epub 2013 Apr 11.
PubMed 23578677Tabesh A, Jensen JH, Ardekani BA, Helpern JA. Estimation of tensors and tensor-derived measures in diffusional kurtosis imaging. Magn Reson Med. 2011 Mar;65(3):823-36. doi: 10.1002/mrm.22655. Epub 2010 Oct 28.
PubMed 21337412De Leener B, Levy S, Dupont SM, Fonov VS, Stikov N, Louis Collins D, Callot V, Cohen-Adad J. SCT: Spinal Cord Toolbox, an open-source software for processing spinal cord MRI data. Neuroimage. 2017 Jan 15;145(Pt A):24-43. doi: 10.1016/j.neuroimage.2016.10.009. Epub 2016 Oct 5.
PubMed 27720818Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.
PubMed 30956204American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
PubMed 12186831Shefner JM, Al-Chalabi A, Baker MR, Cui LY, de Carvalho M, Eisen A, Grosskreutz J, Hardiman O, Henderson R, Matamala JM, Mitsumoto H, Paulus W, Simon N, Swash M, Talbot K, Turner MR, Ugawa Y, van den Berg LH, Verdugo R, Vucic S, Kaji R, Burke D, Kiernan MC. A proposal for new diagnostic criteria for ALS. Clin Neurophysiol. 2020 Aug;131(8):1975-1978. doi: 10.1016/j.clinph.2020.04.005. Epub 2020 Apr 19. No abstract available.
PubMed 32387049Ilieva H, Vullaganti M, Kwan J. Advances in molecular pathology, diagnosis, and treatment of amyotrophic lateral sclerosis. BMJ. 2023 Oct 27;383:e075037. doi: 10.1136/bmj-2023-075037.
PubMed 37890889Middleton DM, Shahrampour S, Krisa L, Liu W, Nair G, Jacobson S, Conklin CJ, Alizadeh M, Faro SH, Mulcahey MJ, Mohamed FB. Correlations of diffusion tensor imaging and clinical measures with spinal cord cross-sectional area measurements in pediatric spinal cord injury patients. J Spinal Cord Med. 2023 Nov;46(6):950-957. doi: 10.1080/10790268.2021.1997027. Epub 2021 Dec 2.
PubMed 34855576Shahrampour S, De Leener B, Alizadeh M, Middleton D, Krisa L, Flanders AE, Faro SH, Cohen-Adad J, Mohamed FB. Atlas-Based Quantification of DTI Measures in a Typically Developing Pediatric Spinal Cord. AJNR Am J Neuroradiol. 2021 Sep;42(9):1727-1734. doi: 10.3174/ajnr.A7221. Epub 2021 Jul 29.
PubMed 34326104Fisher J, Alizadeh M, Middleton D, Matias CM, Mulcahey MJ, Calhoun-Thielen C, Mohamed FB, Krisa L. Brain White Matter Abnormality Induced by Chronic Spinal Cord Injury in the Pediatric Population: A Preliminary Tract-based Spatial Statistic Study. Top Spinal Cord Inj Rehabil. 2021 Fall;27(4):1-13. doi: 10.46292/sci20-00018. Epub 2021 Jun 4.
PubMed 34866884Alizadeh M, Manmatharayan AR, Johnston T, Thalheimer S, Finley M, Detloff M, Sharan A, Harrop J, Newburg A, Krisa L, Mohamed FB. Graph theoretical structural connectome analysis of the brain in patients with chronic spinal cord injury: preliminary investigation. Spinal Cord Ser Cases. 2021 Jul 17;7(1):60. doi: 10.1038/s41394-021-00424-3.
PubMed 34274953Foust KD, Salazar DL, Likhite S, Ferraiuolo L, Ditsworth D, Ilieva H, Meyer K, Schmelzer L, Braun L, Cleveland DW, Kaspar BK. Therapeutic AAV9-mediated suppression of mutant SOD1 slows disease progression and extends survival in models of inherited ALS. Mol Ther. 2013 Dec;21(12):2148-59. doi: 10.1038/mt.2013.211. Epub 2013 Sep 6.
PubMed 24008656Ilieva HS, Yamanaka K, Malkmus S, Kakinohana O, Yaksh T, Marsala M, Cleveland DW. Mutant dynein (Loa) triggers proprioceptive axon loss that extends survival only in the SOD1 ALS model with highest motor neuron death. Proc Natl Acad Sci U S A. 2008 Aug 26;105(34):12599-604. doi: 10.1073/pnas.0805422105. Epub 2008 Aug 21.
PubMed 18719118Nair J, Welch JF, Marciante AB, Hou T, Lu Q, Fox EJ, Mitchell GS. APOE4, Age, and Sex Regulate Respiratory Plasticity Elicited by Acute Intermittent Hypercapnic-Hypoxia. Function (Oxf). 2023 Jun 13;4(5):zqad026. doi: 10.1093/function/zqad026. eCollection 2023.
PubMed 37575478Welch JF, Nair J, Argento PJ, Mitchell GS, Fox EJ. Acute intermittent hypercapnic-hypoxia elicits central neural respiratory motor plasticity in humans. J Physiol. 2022 May;600(10):2515-2533. doi: 10.1113/JP282822. Epub 2022 Apr 28.
PubMed 35348218
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Respiratory Impairments in ALS: A Novel Diagnostic Approach
- ClinicalTrials.gov ID
- NCT07844590
- Acronym / sponsor ID
- 22D.834
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- Amyotrophic lateral sclerosis, Early diagnosis, Respiratory function, Respiratory impairment, Respiratory biomarkers, Biomarkers, Neuroimaging, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Sep 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 28 Sep 2026 (actual)
- 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.
The goal of this observational study is to develop new ways to detect early changes associated with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The study will examine whether changes in breathing, magnetic resonance imaging (MRI) of the brainstem and spinal cord, and blood markers can identify early signs of ALS before major physical changes occur.
The main questions the study aims to answer are:
- Can changes in automatic breathing help identify early ALS-related changes?
- Can breathing measures distinguish people with ALS from people without ALS?
- Do people with genetic risk for ALS who show changes in breathing also have changes in the brainstem and spinal cord or higher levels of blood markers associated with nerve damage?
Participants will complete breathing and muscle function tests, an MRI scan of the brainstem and spinal cord, and blood testing. The study will include people with ALS, people with genetic risk for ALS who do not yet have symptoms, and healthy adults for comparison.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Symptomatic Amyotrophic Lateral Sclerosis | – | –Participants with symptomatic amyotrophic lateral sclerosis (ALS), including familial or sporadic ALS, who have clinical evidence of disease. This group will undergo study assessments to characterize respiratory function and biomarkers associated with ALS. |
| Asymptomatic/Presymptomatic ALS Gene Carriers | – | –Participants who carry a genetic variant associated with amyotrophic lateral sclerosis but do not have clinical symptoms or functional deficits associated with ALS. This group will be evaluated for early or subclinical changes in respiratory function and other biomarkers associated with ALS. |
| Healthy Controls | – | –Neurologically healthy participants without clinically identifiable neurological deficits who will serve as a comparison group for the study assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adults with symptomatic ALS, asymptomatic or presymptomatic individuals with genetic variants associated with ALS, and healthy age- and sex-matched controls. Participants with ALS or genetic risk for ALS will be recruited from Thomas Jefferson University and other ALS patient inventories and referral sources.
Key inclusion criteria (3 listed)
- Symptomatic participants with ALS must have an ALS Functional Rating Scale-Revised (ALSFRS-R) score of 47/48 or less at the time of recruitment.
- Asymptomatic/presymptomatic participants must have a pathogenic C9orf72 expansion of at least 25 repeats or a similar genetic abnormality known to be associated with ALS.
- Healthy control participants must have no clinically identifiable neurological deficits based on medical history and screening. -
Key exclusion criteria (7 listed)
- Any safety concern or contraindication to MRI based on MRI safety screening.
- Healthy control participants who do not pass the neurological screening.
- Pregnancy.
- Metal implants above the waist, including cardiac pacemakers or brain, neck, cervical, or thoracic implants.
- Neurocognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of the Automatic Breathing Impairment Risk Score (P0.1 + Chemosensitivity) for Detecting ALS-Related Respiratory Dysfunction
Time frame: During the single study visit
A linear prediction risk score combining airway occlusion pressure at 0.1 seconds (P0.1) and chemosensitivity will be developed to distinguish symptomatic ALS participants with respiratory dysfunction from healthy controls. Diagnostic performance of the risk score will be evaluated using the area under the receiver operating characteristic curve (ROC-AUC), and an optimal cutoff will be determined. The resulting cutoff will subsequently be used to identify subclinical respiratory impairment in asymptomatic/presymptomatic ALS gene carriers.
6 secondary outcomes
Fractional Anisotropy of the Brainstem and Cervical Spinal Cord
Time frame: During the single study visit
Axial Diffusivity of the Brainstem and Cervical Spinal Cord
Time frame: During the single study visit
Radial Diffusivity of the Brainstem and Cervical Spinal Cord
Time frame: During the single study visit
Mean Diffusivity of the Brainstem and Cervical Spinal Cord
Time frame: During the single study visit
Plasma Neurofilament Light Chain (Nf-L) Level
Time frame: During the single study visit
Serum Neurofilament Light Chain (Nf-L) Level
Time frame: During the single study visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 23578677Raz E, Bester M, Sigmund EE, Tabesh A, Babb JS, Jaggi H, Helpern J, Mitnick RJ, Inglese M. A better characterization of spinal cord damage in multiple sclerosis: a diffusional kurtosis imaging study. AJNR Am J Neuroradiol. 2013 Sep;34(9):1846-52. doi: 10.3174/ajnr.A3512. Epub 2013 Apr 11.
- Background: PubMed 21337412Tabesh A, Jensen JH, Ardekani BA, Helpern JA. Estimation of tensors and tensor-derived measures in diffusional kurtosis imaging. Magn Reson Med. 2011 Mar;65(3):823-36. doi: 10.1002/mrm.22655. Epub 2010 Oct 28.
- Background: PubMed 27720818De Leener B, Levy S, Dupont SM, Fonov VS, Stikov N, Louis Collins D, Callot V, Cohen-Adad J. SCT: Spinal Cord Toolbox, an open-source software for processing spinal cord MRI data. Neuroimage. 2017 Jan 15;145(Pt A):24-43. doi: 10.1016/j.neuroimage.2016.10.009. Epub 2016 Oct 5.
- Background: PubMed 30956204Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.
- Background: PubMed 12186831American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
- Background: PubMed 32387049Shefner JM, Al-Chalabi A, Baker MR, Cui LY, de Carvalho M, Eisen A, Grosskreutz J, Hardiman O, Henderson R, Matamala JM, Mitsumoto H, Paulus W, Simon N, Swash M, Talbot K, Turner MR, Ugawa Y, van den Berg LH, Verdugo R, Vucic S, Kaji R, Burke D, Kiernan MC. A proposal for new diagnostic criteria for ALS. Clin Neurophysiol. 2020 Aug;131(8):1975-1978. doi: 10.1016/j.clinph.2020.04.005. Epub 2020 Apr 19. No abstract available.
- Background: PubMed 37890889Ilieva H, Vullaganti M, Kwan J. Advances in molecular pathology, diagnosis, and treatment of amyotrophic lateral sclerosis. BMJ. 2023 Oct 27;383:e075037. doi: 10.1136/bmj-2023-075037.
- Background: PubMed 34855576Middleton DM, Shahrampour S, Krisa L, Liu W, Nair G, Jacobson S, Conklin CJ, Alizadeh M, Faro SH, Mulcahey MJ, Mohamed FB. Correlations of diffusion tensor imaging and clinical measures with spinal cord cross-sectional area measurements in pediatric spinal cord injury patients. J Spinal Cord Med. 2023 Nov;46(6):950-957. doi: 10.1080/10790268.2021.1997027. Epub 2021 Dec 2.
- Background: PubMed 34326104Shahrampour S, De Leener B, Alizadeh M, Middleton D, Krisa L, Flanders AE, Faro SH, Cohen-Adad J, Mohamed FB. Atlas-Based Quantification of DTI Measures in a Typically Developing Pediatric Spinal Cord. AJNR Am J Neuroradiol. 2021 Sep;42(9):1727-1734. doi: 10.3174/ajnr.A7221. Epub 2021 Jul 29.
- Background: PubMed 34866884Fisher J, Alizadeh M, Middleton D, Matias CM, Mulcahey MJ, Calhoun-Thielen C, Mohamed FB, Krisa L. Brain White Matter Abnormality Induced by Chronic Spinal Cord Injury in the Pediatric Population: A Preliminary Tract-based Spatial Statistic Study. Top Spinal Cord Inj Rehabil. 2021 Fall;27(4):1-13. doi: 10.46292/sci20-00018. Epub 2021 Jun 4.
- Background: PubMed 34274953Alizadeh M, Manmatharayan AR, Johnston T, Thalheimer S, Finley M, Detloff M, Sharan A, Harrop J, Newburg A, Krisa L, Mohamed FB. Graph theoretical structural connectome analysis of the brain in patients with chronic spinal cord injury: preliminary investigation. Spinal Cord Ser Cases. 2021 Jul 17;7(1):60. doi: 10.1038/s41394-021-00424-3.
- Background: PubMed 24008656Foust KD, Salazar DL, Likhite S, Ferraiuolo L, Ditsworth D, Ilieva H, Meyer K, Schmelzer L, Braun L, Cleveland DW, Kaspar BK. Therapeutic AAV9-mediated suppression of mutant SOD1 slows disease progression and extends survival in models of inherited ALS. Mol Ther. 2013 Dec;21(12):2148-59. doi: 10.1038/mt.2013.211. Epub 2013 Sep 6.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in study publications will be shared. Data may include demographic and clinical data, functional respiratory measurements, brainstem and spinal cord MRI data, and blood biomarker data, including neurofilament light chain measurements. Data will be shared without direct participant identifiers and in accordance with applicable data use agreements and institutional requirements.
Related trials for Amyotrophic Lateral Sclerosis (ALS)
Not yet recruitingPhase 1
A Study of Single Ascending Doses of NI112 in Adults With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Anticipated Patient and Caregiver Burden
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis (ALS), run by Thomas Jefferson University 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jayakrishnan Nair, PhD, PT (352-871-5888, Jayakrishnan.Nair@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of the Automatic Breathing Impairment Risk Score (P0.1 + Chemosensitivity) for Detecting ALS-Related Respiratory Dysfunction (time frame: During the single study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07844590, which also lists 59 linked publications.
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 28 Sep 2026.