Abstract:

Hyperbaric Oxygen Therapy (HBO2) has been credited with some anecdotal success in the treatment of Lyme disease and may indeed demonstrate some specific medical efficacy as an adjunctive therapy in Chronic Refractory Lyme Disease as additional scientific studies are conducted. The already large and growing local population of disabled Lyme patients has compelled Life Support Technologies, Inc. and The Mount Vernon Hospital to initiate this Clinical Investigation.

The objective of this hospital-based clinical study is to determine if a course of adjunctive HBO2 exposures in addition to optimized antibiotic therapy will make a demonstrable change in the condition of disabled patients suffering from the chronic neurological phase of Lyme Disease, chronic neuroboreliosis. The Study is limited to those patients that have received courses of conventional antibiotic therapy without significant improvement

The terminal objective of the study is to identify a specific combination of chronic Lyme treatments and develop an optimum treatment protocol towards a cure and eventual medical insurance reimbursement.

Patient referrals to this program can only be accepted from physicians treating Lyme Disease. Each patient will receive 3 hyperbaric exposures per week on alternating days for 20 weeks leading to a total of 60 hyperbaric exposures under the study.

The study will, in part, utilize two biochemical "markers" that may permit investigators to track biochemical mechanisms within the Jarisch-Herxheimer response, often seen in Lyme patients undergoing IV antibiotic therapy, and recently shown to cause a similar response during exposure to Hyperbaric Oxygen.

A Lyme Urine Antigen Test and plasma levels of Tumor Necrosis Factor will be measured weekly in order to help quantitate the effectiveness of HBO2 exposure and track the Jarisch-Herxheimer reaction respectively. Baseline comprehensive neuropsychological testing will be conducted and repeated after every 20 HBO2 exposures in order to quantitate any change in neuropsychological performance. In addition, SPECT scans will be used to visualize pre and post HBO2 exposure CNS perfusion.