Trial record 5 of 259 for:    Amyotrophic Lateral Sclerosis (ALS)

Therapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Bradley Foerster M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT02058732
First received: November 8, 2013
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

Study the cervical spinal cord and brain over time to assess changes and differences in subjects with amyotrophic lateral sclerosis.


Condition Intervention
Amyotrophic Lateral Sclerosis
Procedure: ALS Patients receiving stem cells
Procedure: ALS patients not receiving stem cells

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Therapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Changes in spinal cord metabolites in treated ALS subjects and nontreated ALS subjects. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    1. The longitudinal changes in spinal cord metabolites in amyotrophic lateral sclerosis(ALS) stem cell treated patients will be compared to amyotrophic lateral sclerosis(ALS) non-treated patients using magnetic resonance spectroscopy. Investigators hypothesize that amyotrophic lateral sclerosis(ALS) stem cell treated patients will demonstrate attenuated rates of decline in the levels of N-acetylaspartate(NAA), a measure of neuronal integrity, in the cervical spinal cord than amyotrophic lateral sclerosis(ALS) non-treated patients.


Estimated Enrollment: 17
Study Start Date: November 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ALS patients receivng stem cells
Amyotrophic lateral sclerosis(ALS)subjects, who will be receiving stem cells, will undergo a brief clinical evaluation and questionnaire that will last approximately 20 to 30 min. Subjects will be asked to undergo magnetic resonance imaging(MRI)scans of the cervical spine and brain that will last approximately 60 minutes.
Procedure: ALS Patients receiving stem cells
Subjects will have an MRI that lasts approximately 60 minutes at the same time points as during the stem cell study schedule; once before the stem cell surgery, and again at 1, 6, 12, 18, 24, 36, and 48 months after receiving stem cells. This magnetic resonance imaging(MRI)scan will be of the cervical spine and brain.
Procedure: ALS patients not receiving stem cells
Amyotrophic lateral sclerosis patients who will not receive stem cells will have a magnetic resonance imaging(MRI)scan. This scan will be of the cervical spine and brain. The scan will last approximately 60 minutes. This MRI scan will be repeated at both 6 and 12 months. Subjects will also complete a clinical examination that takes about 30 minutes for each MRI scan.
Active Comparator: ALS patients not receiving stem cells
Amyotrophic lateral sclerosis(ALS)patient who will not be receiving stem cells, will have an MRI that lasts approximately 60 minutes. This MRI will be repeated at three different time points. Subjects will have an initial MRI, then another at both 6 and 12 months after the initial magnetic resonance imaging(MRI)scan. Subjects will also complete a clinical examination which will take approximately 30 minutes for each MRI. The follow-up magnetic resonance imaging(MRI)scans done for ALS patients who do not receive stem cells are part of routine clinical studies and therefore subjects will not be billed.
Procedure: ALS Patients receiving stem cells
Subjects will have an MRI that lasts approximately 60 minutes at the same time points as during the stem cell study schedule; once before the stem cell surgery, and again at 1, 6, 12, 18, 24, 36, and 48 months after receiving stem cells. This magnetic resonance imaging(MRI)scan will be of the cervical spine and brain.
Procedure: ALS patients not receiving stem cells
Amyotrophic lateral sclerosis patients who will not receive stem cells will have a magnetic resonance imaging(MRI)scan. This scan will be of the cervical spine and brain. The scan will last approximately 60 minutes. This MRI scan will be repeated at both 6 and 12 months. Subjects will also complete a clinical examination that takes about 30 minutes for each MRI scan.

Detailed Description:

Investigators will study cervical spinal cord chemical concentrations and cervical spinal cord and brain microstructure in amyotrophic lateral sclerosis(ALS) patients who have had a stem cell transplant compared to ALS patients who have not had a stem cell transplant. Investigators intend to determine cervical spinal cord chemical concentrations and cervical spinal cord and brain microstructure in amyotrophic lateral sclerosis(ALS) patients who have had a stem cell transplant and compare these to corresponding measures in amyotrophic lateral sclerosis(ALS) patients who have not had a stem cell transplant.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Subjects with amyotrophic lateral sclerosis -

Exclusion Criteria:

  1. Do not have opportunistic central nervous system infection
  2. Do not have a history of head injury
  3. Do not have cerebrovascular disease
  4. Do not have a contraindication for MRI(e.g. cardiac pacemaker, ferromagnetic or metallic implants).
  5. Must not be pregnant -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02058732

Contacts
Contact: Bradley Foerster, M.D. 734-615-3586
Contact: Ladonna Austin, CCRC 734-936-8275 ladonna@umich.edu

Locations
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Bradley Foerster, M.D.    734-615-3586      
Principal Investigator: Bradley Foerster, M.D.         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Bradley Foerster, M.D. University of Michigan Hospital
  More Information

No publications provided

Responsible Party: Bradley Foerster M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT02058732     History of Changes
Other Study ID Numbers: HUM00078370
Study First Received: November 8, 2013
Last Updated: August 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014