Prospective Observational Study of Patient Outcomes after various interventions for Spontaneous Intracranial Hypotension

Summary

Spontaneous intracranial hypotension (SIH) is a neurological disorder caused by a spinal cerebrospinal fluid leak. For many patients, this condition leads to severe headaches and other neurological symptoms such as a disturbed sense of balance and changes in hearing. Although much has been learned about this condition over the years, most studies have collected data from the past (retrospective), rather than collecting data as things happen (prospectively). In addition, a study looking at patient outcomes after different types of treatments has not been done. Longer-term outcomes have also not been previously studied. Both short-term and long-term outcomes need to be studied to understand patient outcomes shortly after interventions, and also months or years later.

The purpose of this study is to prospectively and systematically collect data on patients diagnosed with SIH, and assess patient outcomes at the time of the first visit to three centers participating in the study: Cedars-Sinai Medical Center, University of Calgary Headache clinic, and University of Toronto CSF Leak clinic (baseline), and then following their intervention, for several time points.

Interventions will include any percutaneous procedures (blood patching and fibrin glue), endovascular embolization, and spine surgery. Outcomes will include measures or scales assessing clinical changes, disability, depression, anxiety, quality of life and a global assessment of change. If patients are not suitable for any interventions or choose not to undergo any interventions but agree to participate in this study, data collection will still occur at appropriate time intervals. This may allow an understanding of the natural history of this illness.