Skip to content

Therapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis

Therapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02058732
Enrollment
6
Registered
2014-02-10
Start date
2013-11-30
Completion date
2015-09-30
Last updated
2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Brief summary

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

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.

Interventions

OTHERMRI

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.

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 -

Design outcomes

Primary

MeasureTime frameDescription
Changes in spinal cord metabolites in treated ALS subjects and nontreated ALS subjects.5 years1\. 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026