Spinal CSF leaks are considered as rare disease. They cause a variety of symptoms, mainly culminating in a chronic headache syndrome. Crucially, yet often disregarded, the disease holds the potential for cure. The multitude of symptoms, and their inconsistency over time are just two of many challenges preventing timely diagnosis and treatment in many patients.
Spinal CSF leaks can occur after intentional or accidental dural puncture (post-dural puncture headache - PDPH) or spontaneously (spontaneous intracranial hypotension - SIH). Awareness is steadily increasing with simultaneous increase of recognized patients. Yet, research and diagnostic is mainly provided by few specialized centers, as e.g. Freiburg. Thus, many observations point towards a large non-diagnosed and non-recognized number of patients, most likely being misdiagnosed and mistreated.
Objective: The aim of the registry is to collect structured information on the frequency, cause, symptoms, diagnostic procedures, treatment options and long-term outcome. With the help of the registry, we would like to contribute to a better understanding and treatment of the diseases.
Methods: Prospective, longitudinal registry on patients with suspected SIH or PDPH, including data on demographics, clinical presentation, diagnostic findings, treatment, at treatment outcome.
Patients with suspected spinal CSF leak based on one of the following
History of new orthostatic symptomes with or without prior spinal procedure
Imaging suggestive for spinal CSF leak
Informed consent
None
The registry is an explorative study on patients suffering from a rare disease - therefor it is aimed to include all eligible patients for a time-limit of 10 years. All patients with suspected spinal CSF leak will be approached and informed about the registry. In case of legal incapacity, the caregivers will be approached. The inclusion of this vulnerable group is considerable as they represent a small but very important subgroup of patients suffering from demntia stemming from a traetable cause.
Cohort
Prospective
Not listed
Primary Diagnosis given after primary workup (yes/no)
* SIH (fulfilling ICHD-3 criteria) - yes/no * atypical SIH - yes/on * Asymptomatic SIH (positive imaging signs only) - yes/no * PDPH (fulfilling ICHD-3-criteria) - yes/no * persistentPDPH - yes/no
SIH/PDPH - Experience of the local team
Number of patient with suspicion for SIH work-up/year
SIH/PDPH - Patients' demographics
Country, City
SIH - Previously received treatment at time of inclusion (yes/no)
Medical SIH treatment, Other symptomatic treatment, Untargeted lumbar blood patch, Targeted blood patch, Targeted fibrin patch, Endovascular embolization, Minimally invasive surgery, Open surgery - dorsal approach, Open surgery-ventral approach, Open surgery-transforaminal approach, Discectomy, Laminectomy, Stabilization procedures, Surgery, other techniques
SIH/PDPH - age
years
SIH/PDPH - Follow up-Reported adverse events related to treatment (yes/no)
Rebound hypertension, Reoccurrence of the leak, Suture insufficiency, Bleeding, Sensory deficits, Motor deficits, Gait ataxia, Bladder dysfunction, Bowl dysfunction, Others
SIH/PDPH - Follow up-Duration of treatment for rebound hypertension after therapy of the CSF leak
days
SIH/PDPH - Follow up-Average dosage of acetazolamide per day
mean mg/d
SIH/PDPH - Follow up - Total Bern-Score, according to Dobrocky et al.
range 0 to 9, 9 indicating highest likelihood of spinal CSF leak
Click on the lead sponsor to view all of their trials.
