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Official Study Title: Cellular and Molecular Kinetics of Cerebrospinal Fluid (CSF) Using Heavy Water Labeling Method: A Study of Healthy Controls, CNS HIV Infection, Parkinson’s Disease, and Other Neurodegenerative Diseases
Sponsor: University of California, San Francisco (Investigator-initiated)
Clinicaltrials.gov ID:
Study ID: 6076

Summary

This pilot study will assess the feasibility of using heavy water as a safe ‘tracer’ for biomarker studies of diseases of the brain and spinal cord, that, together, are also called the central nervous system (CNS).  Heavy water, also called deuterated water or D20, is the same as normal drinking water except the hydrogen atoms have been replaced by deuterium, a naturally occurring isotope of hydrogen.  In particular, this study will use heavy water to define: 1) The rate of immune cell proliferation (growth) in the cerebrospinal fluid (CSF) compared to blood.  This study will be examining a particular type of immune cell called T lymphocytes. 2) This study will also examine selected molecules generated by nerve cells of the CNS to understand their rate of secretion and turnover in healthy control participants, HIV-1-infected participants and participants with a non-HIV-related neurodegenerative disease such as Parkinson’s disease (PD).

This study will involve the administration of heavy water orally for either seven days, 12 days or six weeks.  Measurements will be taken by lumbar puncture (LP, also known as a spinal tap).  Blood (approximately five tablespoons per visit) will also be obtained at each of the lumbar puncture appointments.

If this method can be used to establish the rates of immune cell turnover and the production rates of neuronal molecules using cerebrospinal fluid, it will provide unique data that is important to understand chronic neurodegenerative conditions, like PD, and to measure responses to targeted therapies.

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

• Less than one month
• 5-6 appointments. Each lumbar puncture appointment will take approximately 3 hours. Total time commitment is 10-17 hours.

Eligibility

• Minimum Age: 18
• Gender(s) Accepted: Either
• Minimum Years Since Diagnosis: 1

Inclusion Criteria

PD Participants

• Diagnosis of PD Features characteristic of PD such as: Resting tremor,  Resting TremorA tremor of a limb that increases when the limb is at rest. Bradykinesia,  BradykinesiaSlowness of movement. Rigidity  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. or Asymmetric onset
• Over 18 years of age
• Capacity to provide informed consent

Exclusion Criteria

• Any contraindication to lumbar puncture including bleeding diathesis (history of unusual bleeding)
• Pregnancy or expectation of pregnancy during study
  

Enrollment

Expected Enrollment: 30 (US)
Date Enrollment Began: May 2009
Date Enrollment Ends: Sep 2011
Last Updated Date: May 05 2011
Trial Post Date: Sep 08 2009
Website:

Primary Contacts and Locations

California

• Marc Hellerstein, MD, PhD
  march@berkeley.edu
  Phone: (510) 655-6525 ext. 103
  Emeryville, CA 94608
  USA
  
• Drina Boban, MPH
  divab3@berkeley.edu
  Phone: (415) 215-0202
  Emeryville, CA 94608
  USA
  

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