Serum Auto-Antibodies in Neurological Diseases

Brief Title

Serum Auto-Antibodies in Neurological Diseases

Official Title

CCRC: Serum Auto-Antibodies in Neurological Disease

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Observational


Primary Outcome

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.


Condition

Multiple Sclerosis

Intervention

Blood Draw

Study Arms / Comparison Groups

 Cohort 1
Description:  Subjects with multiple sclerosis and other autoimmune and inflammatory disease of the nervous system

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

120

Start Date

January 2002

Completion Date

March 2031

Primary Completion Date

March 2031

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

David Richman, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00704626

Organization ID

215828


Responsible Party

Sponsor

Study Sponsor

University of California, Davis


Study Sponsor

David Richman, MD, Principal Investigator, University of California, Davis


Verification Date

March 2021