Serum Auto-Antibodies in Neurological Diseases
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Neurology, Neurology, Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/23/2019 |
| Start Date: | January 2002 |
| End Date: | December 2020 |
CCRC: Serum Auto-Antibodies in Neurological Disease
Under normal conditions our immune system protects us against infections and tumors. The
immune system does this by recognizing that the infecting organism or the tumor is foreign to
the body and attacking it. One way the immune system attacks a foreign target is by making
proteins called antibodies that bind to the target. Sometimes, for reasons we poorly
understand, the immune system wrongly identifies part of our own body as being foreign and
attacks it. This can result in disease such as some forms of diabetes and thyroid disease, as
well as some neurological diseases. In this study, one tablespoon of blood will be removed
from each subject and tested to see if the immune system is making antibodies against
components of the nerves and muscles. We also hope to learn if these antibodies contribute to
the development or worsening of illnesses of the nervous system. Only one blood draw is
required, but subjects may be asked to give up to 8 additional blood samples to see if the
level of antibodies changes over time. Any additional blood draws would be performed at
regularly scheduled clinic visits. There would be at least 3 months between blood draws over
a period of up to 3 years, if requested by the physician.
Depending on your diagnosis, the physician may also request the collection of mouth (buccal)
cells. This takes about one minute and is painless. The cells are collected by swishing a
swab around your mouth. This cheek swab would be done with each blood draw.
Please note that this study is conducted ONLY at UC Davis and that all participants must be
seen in our clinic located in Sacramento, CA. Results of the testing performed in this study
are not given to the participants. This study is not intended to treat or diagnose any
condition.
immune system does this by recognizing that the infecting organism or the tumor is foreign to
the body and attacking it. One way the immune system attacks a foreign target is by making
proteins called antibodies that bind to the target. Sometimes, for reasons we poorly
understand, the immune system wrongly identifies part of our own body as being foreign and
attacks it. This can result in disease such as some forms of diabetes and thyroid disease, as
well as some neurological diseases. In this study, one tablespoon of blood will be removed
from each subject and tested to see if the immune system is making antibodies against
components of the nerves and muscles. We also hope to learn if these antibodies contribute to
the development or worsening of illnesses of the nervous system. Only one blood draw is
required, but subjects may be asked to give up to 8 additional blood samples to see if the
level of antibodies changes over time. Any additional blood draws would be performed at
regularly scheduled clinic visits. There would be at least 3 months between blood draws over
a period of up to 3 years, if requested by the physician.
Depending on your diagnosis, the physician may also request the collection of mouth (buccal)
cells. This takes about one minute and is painless. The cells are collected by swishing a
swab around your mouth. This cheek swab would be done with each blood draw.
Please note that this study is conducted ONLY at UC Davis and that all participants must be
seen in our clinic located in Sacramento, CA. Results of the testing performed in this study
are not given to the participants. This study is not intended to treat or diagnose any
condition.
The purposes of the study are to determine the frequency of auto-antibodies to 1) heat shock
proteins and 2) to other molecules including cytoskeletal proteins such as rapsyn in diseases
of the nervous system.
5cc of serum will be obtained from patients with multiple sclerosis and other autoimmune and
inflammatory diseases of the nervous system including myasthenia gravis and transverse
myelitis and from patients with other neurological diseases. Standard methodology to assure
safe handling of serum will be used. Diluted serum will be tested for specific reactivity
with heat shock proteins (Sigma Chemical Co., St. Louis, MO) as well as with other antigens
in a standard ELISA as well as immunoblot.
Buccal swab will also be obtained in conjunction with each blood draw. Rapsyn and other
cytoskeletal proteins will be extracted from Torpedo californica electric organ by means of
differential centrifugation followed by alkali extraction. For the ELISA, a standard
titration curve will be obtained for a positive control serum as previously determined.
Negative control sera will be obtained from individuals with other degenerative neurological
diseases. Titers of test serum will be determined as the dilution that generates a positive
result that is two standard deviations from the mean of the background. Positive ELISA
results will be confirmed by immunoblot. Patients may be tested at one time point only. If
the serum is positive for specific antibody binding, additional serum samples may be obtained
and retested up to 8 more times approximately 3 months apart. Correlation with severity of
clinical findings and specific antibody titer will be made. Severity of clinical findings
will be determined by the neurological exam done by the investigator.
proteins and 2) to other molecules including cytoskeletal proteins such as rapsyn in diseases
of the nervous system.
5cc of serum will be obtained from patients with multiple sclerosis and other autoimmune and
inflammatory diseases of the nervous system including myasthenia gravis and transverse
myelitis and from patients with other neurological diseases. Standard methodology to assure
safe handling of serum will be used. Diluted serum will be tested for specific reactivity
with heat shock proteins (Sigma Chemical Co., St. Louis, MO) as well as with other antigens
in a standard ELISA as well as immunoblot.
Buccal swab will also be obtained in conjunction with each blood draw. Rapsyn and other
cytoskeletal proteins will be extracted from Torpedo californica electric organ by means of
differential centrifugation followed by alkali extraction. For the ELISA, a standard
titration curve will be obtained for a positive control serum as previously determined.
Negative control sera will be obtained from individuals with other degenerative neurological
diseases. Titers of test serum will be determined as the dilution that generates a positive
result that is two standard deviations from the mean of the background. Positive ELISA
results will be confirmed by immunoblot. Patients may be tested at one time point only. If
the serum is positive for specific antibody binding, additional serum samples may be obtained
and retested up to 8 more times approximately 3 months apart. Correlation with severity of
clinical findings and specific antibody titer will be made. Severity of clinical findings
will be determined by the neurological exam done by the investigator.
Inclusion Criteria:
- 18 years or older
- Diagnosis of multiple sclerosis, myasthenia gravis, or other autoimmune or
inflammatory neurological disease
Exclusion Criteria:
- inability to give informed consent
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