Clinical trial NCT06711731: The Freiburg Registry on SpontanEous IntercrAnial Hypotension (SIH) & Post-duraL Puncture Headache (PDPH)
Official title: The Freiburg Registry on SpontanEous IntercrAnial Hypotension (SIH) & Post-duraL Puncture Headache (PDPH)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CerebroSpinal Fluid (CSF) Leak
Keywords: SIH
PDPH
Spinal leaks
CSF leak
SLEC
Spontaneouse Intercranial Hypotension
CSF-venous fistula
Post Dural Puncture Headache
Cerebrospinal Fluid Leak
Rare disease
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: Spinal CSF leaks have a severe impact on quality of life and health. Symptoms vary from chronic headache syndrome to intracranial bleeding, cognitive decline, and coma. Crucially, yet often disregarded, the disease holds the potential for cure.

Lumbar dural leaks can arise from commonly performed medical interventions such as diagnostic lumbar punctures, spinal anesthesia, spinal infiltrations, or incidental dural punctures during epidural analgesia in obstetric care, resulting in post-dural puncture headache (PDPH).

Additionally, a notable fraction of spinal CSF leaks manifests as spontaneous intracranial hypotension (SIH), which derives from different types of spontaneous leaks along the Spine and remains broadly under-recognized.

The main clinical symptoms of spinal CSF leaks are orthostatic headaches with a most often defined beginning, typically accompanied by hearing impairment and dizziness, worsened by exercise and movement. Additionally, other manifestations are known, such as cognitive decline, bilateral brachial amyotrophy, paradox headache, fatigue, and many more. In patients presenting with spinal CSF leaks, the accurate diagnosis often eludes clinicians, leading to frequent misdiagnoses of chronic migraine, fatigue, or psychiatric conditions. Many patients endure months, if not years, before a diagnosis of a treatable condition is finally established. The heterogeneity of the symptoms can appear inconsistent or even paradoxical, posing diagnostic challenges. The extent of possible long-term deterioration is not recognized.

The reported incidence of PDPH fluctuates considerably, ranging from 2 to 40 per 100 procedures performed. This variance is influenced by patient-related factors (e.g., age, gender, pregnancy status) and procedural factors (e.g., needle size and type). PDPH, according to current criteria, occurs within 5 days after a dural puncture. Nevertheless, there are widely underestimated pitfalls: a dural puncture is not always recognized by the person performing an epidural procedure, symptoms can occur after more than 5 days, and disease courses can be chronic. These facts are widely unknown, leading to largely hidden figures of patients being under or misdiagnosed and, thus, not treated. Moreover, PDPH is primarily observed following unintentional dural puncture during the administration of obstetric anaesthesia and analgesia to parturients.

Spontaneous intracranial hypotension (SIH) can be caused by ventral, lateral, or sacral spinal leaks or by CSF-venous fistulae, which was first described in 2014. An annual incidence rate of \~ 4/100,000 was estimated in 2022. This rate is likely underestimated as it only includes confirmed cases, thus recognized cases within a widely non-recognized entity. Often, patients are neither identified nor directed to the appropriate MRI, which, in numerous instances, could lead to the correct diagnosis. Even when SIH is identified, non-targeted epidural blood patches in the lumbar region are often not administered due to perceived elevated risks. An epidural blood patch might be able to help to heal the leak. At the same time, it must be noted that even long-term improvement does not necessarily indicate closure of the leak and prevention of long-term sequelae, such as superficial siderosis. Invasive diagnostics are not employed to pinpoint the location, and treatment to seal the leak is not consistently pursued. The effects of treatment are often immediate and can be successful even in chronic patients. Evidence shows that leaks are held open by new membranes (Neo-membranes) that prevent spontaneous healing. Thus, the correct localization of such a leak and targeted sealing or close follow-ups should be initiated.

The management approaches for SIH and PDPH significantly deviate from standard pain management strategies employed for other types of headaches. Noteworthy interventions include the application of blood patches and even surgical measures to seal the leak, offering curative solutions. Those enduring chronic spinal CSF leaks experience profound limitations in their health-related quality of life, comparable to those with chronic immunological diseases or cancer. Overlooking the diagnosis and management of spinal CSF leaks may precipitate progressive deterioration, with the potential for persistent sequelae like superficial siderosis, syndromes mimicking frontotemporal dementia (FTD), and chronic subdural hematoma formation.

This registry aims to set ground for standardized, prospective demographic, diagnostic and treatment data assessments, and patient self-reported outcome measures.

Collecting this data is essential to potentially exploring risk factors, understanding outcome predictors, and refining diagnostics. Additionally, standardized data collection will allow the appropriate designing of urgently needed randomized trials.

Aims:

Primary aim:

To describe the proportion of patients diagnosed with SIH or PDPH

Secondary aims:

1. To describe the proportion of different spinal CSF leaks observed per entity
2. To describe the demographics per entity, and per different spinal CSF leak type
3. To describe the clinical spectrum per entity, and per different spinal CSF leak type
4. To describe the imaging features per entity, and per different spinal CSF leak type
5. To describe the outcome of different treatments, and per different spinal CSF leak type
6. To describe the adverse events of different treatments, and per different spinal CSF leak type
7. To explore potential diagnostic markers per entity, and per different spinal CSF leak type
8. To explore risk factors per entity, and per different spinal CSF leak type
9. To evaluate differences between spinal CSF leak types regarding age, sex, BMI, clinical presentation, diagnostic findings
10. To assess the effect of disease duration on imaging findings, and on outcome after persistent closure of a leak

Method:

The registry is prospective, longitudinal and currently monocentric\*. Diagnostic, treatment, and follow-up procedures follow clinical standard operating procedures (SOP) according to the suspected diagnosis and the clinical findings.

Routinely assessed data of the initial diagnostic workup and the individual's disease course with or without treatment will be collected over 2 years per individual. The investigators' semi-annual meetings ensure the achievement of the register's predefined aims.

There are no specific risks or benefits for the patients participating in this registry. Any procedure will be performed according to clinical standards as indicated. There will be no additional visits to the hospital or the ambulatory. There will be no additional imaging performed, especially no additional radiation.

A merely intrinsic benefit might exist for the patient supporting this study and supporting medical research.

As this is an explorative and observational study on rare diseases without formal sample size estimation, we limit the study by time of duration (10 years).

Patients suffering from rare diseases most often face delays in diagnostics and treatments. To underscore this known burden: By an estimated population of 1.74 Mio in the Freiburg area and an incidence rate of SIH of about 5/100.0004, approximately 85 patients should be expected per year stemming from this area. Freiburg is the only center offering adequate diagnostic pipelines for these patients. Despite the increasing awareness, the number of patients diagnosed in the area adjunct to the Freiburg CSF center is within a range of 15 to 20 patients per year, thus still too low compared to the expected number with many patients unrecognized, and or underdiagnosed.

Our current numbers of confirmed SIH treatments range from 100 per year with patients being referred throughout Germany and about 15-20 international patients per year. We expect this rate to rise within the next few years. The number of PDPH patients with a focus on persistent PDPH patients is currently rapidly increasing. We see about 40-60 per year.

Interim-Evaluation of the Registry's primary and secondary descriptive aims will be performed and reported as a step-wise, dynamic approach:

* After each +100 patients with confirmed SIH
* After each +50 patients with confirmed PDPH

The secondary objectives, which involve comparisons, the exploration of diagnostic markers, and risk factors, will be addressed using a dynamic biostatistical model: The analysis will only be conducted after a power analysis deems the observed sample adequate.

Proportions will be presented as a percentage with 95% confidence interval (CI).

The sata of patients with different types of spinal CSF leaks will be summarized using descriptive statistics, i.e. median and quartiles for continuous and absolute and relative frequencies for categorical variables, regarding their clinical, laboratory, and diagnostic findings, and number of diagnostic and therapeutic procedures needed.

Furthermore, the proportion of SIH patients with different spinal CSF leak types

1. will be compared between males and females using a Chi2-Test and a risk difference with 95% CI.
2. Will be presented by age groups (per two decades), and per sex as a percentage with a 95% Wilson confidence interval (CI).

Age, sex, BMI, clinical presentation, and diagnostic findings between different spinal CSF leaks will be compared using the Mann-Whitney-Wilcoxon test and Chi2 test for continuous and categorical variables, respectively.

A multivariable logistic regression for the presence of SIH, PDPH, and chronic PDPH, respectively, will be constructed using the clinical and diagnostic parameters with some evidence for a difference according to the presence of a spinal CSF leak (p \< 0.2). The potential nonlinearity of the age effect is evaluated based on a residual analysis of the regression model. Odds ratios with 95% CI will be reported. Using bootstrapping, we will present a ROC curve and AUC with 95% Due to the exploratory approach,, no correction for multiple testing will be performed.

A multivariable linear regression for imaging findings (especially Bern Score, presence of SLEC, vand olumetries), and for the patient-reported outcomes will be constructed using the clinical and diagnostic parameters at admission with some evidence for a difference (p\<0.2). Adjusted R-squares, Beta-coefficients with 95% CI, standard errors will be reported.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Informed consent

Exclusion Criteria:

a) Symptoms beeing conclusively explained by another known diagnosis

Primary outcomes:
measure: Primary Diagnosis given after primary workup (yes/no)
timeFrame: up to 4 weeks after inclusion
Secondary outcomes:
measure: SIH/PDPH - Experience of the local team
timeFrame: at time of inclusion
measure: SIH/PDPH - Patients' demographics
timeFrame: at time of inclusion
measure: SIH - Previously received treatment at time of inclusion (yes/no)
timeFrame: at time of inclusion
measure: SIH/PDPH - age
timeFrame: at time of inclusion
measure: SIH/PDPH - sex
timeFrame: at time of inclusion
measure: SIH/PDPH - height
timeFrame: at time of inclusion
measure: SIH/PDPH - weight
timeFrame: at time of inclusion
measure: SIH/PDPH - modified Ranking scale
timeFrame: at time of inclusion
measure: SIH/PDPH - pre-existing Neurological deficits (yes/no)
timeFrame: at time of inclusion
measure: SIH/PDPH - Neurological deficits in routine clinical testing
timeFrame: at time of inclusion
measure: SIH - Montreal cognitive Assessment
timeFrame: at time of inclusion
measure: SIH - Trail-making test part B
timeFrame: at time of inclusion
measure: PDPH -BMI
timeFrame: at time of inclusion
measure: SIH/PDPH - Regular use of stimuli > 6 months (yes/no)
timeFrame: at time of inclusion
measure: SIH/PDPH - Headache-Impact-Test (HIT)-6
timeFrame: at time of inclusion
measure: SIH/PDPH - 5 dimensions /5 levels European Quality of life questionaire (EQ-5D-5L) Index
timeFrame: at time of inclusion
measure: SIH/PDPH - Self-Administered Comorbidity Questionaire (SCQ)
timeFrame: at time of inclusion
measure: PDPH - Patient'S Global Impression of Change (PIGC)
timeFrame: at time of inclusion
measure: SIH - Opening pressure on lumbar puncture if performed (not recommended in routine), or myelogram
timeFrame: up to 4 weeks
measure: SIH/PDPH - Total Bern-Score MRI head according to Dobrocky et al.
timeFrame: up to 4 weeks
measure: SIH/PDPH - Subitems Bern-Score MRI head according to Dobrocky et al.
timeFrame: up to 4 weeks
measure: SIH - MRI head - Superficial Siderosis
timeFrame: up to 4 weeks
measure: SIH - MRI head - Layered calvarial hyperostosis
timeFrame: up to 4 weeks
measure: SIH - Sinus vein thrombosis
timeFrame: up to 4 weeks
measure: SIH/PDPH - Volumetry of the CSF-space MRI head & spine
timeFrame: up to 4 weeks
measure: SIH/PDPH - Volumetry of the CNS MRI head & spine
timeFrame: up to 4 weeks
measure: SIH/PDPH - Imaging Density score
timeFrame: up to 4 weeks
measure: SIH/PDPH - Total radiation dose applied per diagnostic procedure with radiation performed
timeFrame: at primary workup
measure: SIH - Myelography number
timeFrame: up to 24 weeks
measure: SIH - Type of myelography technique applied (yes/no)
timeFrame: up to 4 weeks
measure: SIH - Adverse events during myelography (yes/no)
timeFrame: up to 4 weeks
measure: SIH - Headache before and after myelogram
timeFrame: up to 4 weeks
measure: SIH - Positioning during index myelography that proofs the leak (yes/no)
timeFrame: up to 4 weeks
measure: SIH - myelography that proofs the leak performed applying (yes/no)
timeFrame: up to 4 weeks
measure: SIH/PDPH - Lumbar Infusiontest - Pressure at baseline
timeFrame: up to 4 weeks
measure: SIH/PDPH - Lumbar Infusiontest - Resistence to CSF outflow (Rcsf)
timeFrame: up to 4 Weeks
measure: SIH/PDPH - Lumbar Infusiontest - Elastance
timeFrame: up to 4 weeks
measure: SIH/PDPH - Lumbar Infusiontest - Pressure-Volume-Index
timeFrame: up to 4 weeks
measure: SIH/PDPH - Lumbar Infusiontest - Needle resistance
timeFrame: up to 4 weeks
measure: SIH/PDPH - PET-CT - Evidence of CSF-loss (yes/no)
timeFrame: up to 4 weeks
measure: SIH/PDPH - PET-CT if performed -
timeFrame: up tp 4 weeks
measure: SIH/PDPH - Laboratory parameters at diagnosis (normal/abnormal)
timeFrame: up to 4 weeks after inclusion
measure: SIH - CSF leak types identified by dynamic myelography (yes/no)
timeFrame: up to 4 weeks
measure: SIH - Multiples leaks (yes/no)
timeFrame: up to 4 weeks
measure: SIH - Level of spinal CSF leak (spinal segment) and side in myelogram
timeFrame: up to 4 weeks
measure: SIH - In case of surgery: spinal segment and side confirmed? (yes/no)
timeFrame: up to 4 weeks
measure: SIH/PDPH - Experience of leading interventionalist in SIH-diagnostics/year
timeFrame: up to 4 weeks
measure: SIH/PDPH - Disease duration at time of therapy
timeFrame: up to 4 weeks
measure: SIH/PDPH - Therapy performed after CSF leak diagnosis (yes/no)
timeFrame: up to 4 weeks
measure: SIH/PDPH - Experience of leading surgeon in SIH/PDPH-surgeries/year
timeFrame: up to 4 weeks or longer, depending on the number of surgeries
measure: SIH/PDPH - Interventions needed addressing secondary complications of spinal CSF leaks, especially chronic subdural hematoma
timeFrame: up to 4 weeks
measure: PDPH - Event of putative dural puncture
timeFrame: up to 4 weeks
measure: PDPH - Event of putative dural puncture (yes/ no)
timeFrame: up to 4 weeks
measure: SIH/PDPH - adverse events related to current treatment at discharge (yes/no)
timeFrame: up to 4 weeks
measure: PDPH - Lumbar segment of putative dural puncture known (yes/no)
timeFrame: up to 4 weeks
measure: PDPH - Puncture under imaging guidance
timeFrame: up to 4 weeks
measure: PDPH - Duration between (putative) dural puncture until the onset of symptoms
timeFrame: up to 4 weeks
measure: PDPH - Time to first blood patch
timeFrame: up to 4 weeks
measure: PDPH - Number of bloodpatches received before admission
timeFrame: up to 4 weeks
measure: PDPH - Prior treatments at the time of admission (yes/no)
timeFrame: up to 4 weeks
measure: PDPH - Post-dural puncture pseudomeningocele ("arachnoid bleb")
timeFrame: up to 4 weeks
measure: PDPH - Spinal Segment location of the "arachnoid bleb"
timeFrame: up to 4 weeks
measure: PDPH - Identified CSF leak types by dynamics myelography and/or intraoperatively:
timeFrame: up to 4 weeks
measure: PDPH - Intraoperatively Identified membranes (yes/no)
timeFrame: up to 4 weeks
measure: PDPH - Dinosaur-tail sign (yes/no)
timeFrame: at time of inclusion
measure: PDPH - specific segment of identified intraoperative membranes (descriptive)
timeFrame: up to 4 weeks
measure: PDPH - CSF leak types identified by dynamic myelography and/or intraoperatively
timeFrame: up to 4 weeks
measure: PDPH - Diagnostic procedures performed (yes/no, number)
timeFrame: uo to 4 weeks
measure: PDPH - Volume lumbar bloodpatch
timeFrame: up to 4 weeks
measure: SIH/PDPH - work capacity
timeFrame: at time of inclusion
measure: SIH/PDPH -complaints
timeFrame: at time of inclusion
measure: SIH/PDPH - headache severity
timeFrame: at time of inclusion
measure: SIH/PDPH - Days within the last month
timeFrame: at time of inclusion
measure: SIH/PDPH - maximum duration being continuously upright
timeFrame: at time of inclusion
measure: SIH/PDPH - severeness of dizziness
timeFrame: at time of inclusion
measure: SIH/PDPH - Severeness of shoulder- and neck pain
timeFrame: at time of inclusion
measure: SIH/PDPH - severeness of nausea
timeFrame: at time of inclusion
measure: SIH/PDPH - severeness of hearing disturbances and tinnitus
timeFrame: at time of inclusion
measure: SIH/PDPH - severeness of cognitive deficits
timeFrame: at time of inclusion
measure: SIH/PDPH - severeness of visual disturbances
timeFrame: at time of inclusion
measure: SIH/PDPH - . ability to focus and concentrate
timeFrame: at time of inclusion
measure: SIH/PDPH - MRI spine: Spinal longitudinal extradural fluid collection (SLEC) (yes/no)
timeFrame: up to 4 weeks
measure: SIH/PDPH - MRI-spine: DiverTICula (TIC) ≥8mm (yes/no)
timeFrame: up to 4 weeks
measure: SIH/PDPH - Volumetry of epidural spinal veins at C2
timeFrame: up to 4 weeks
measure: SIH/PDPH - MRI spine: Enlarged cervical epidural spinal veins at C2
timeFrame: up to 4 weeks
measure: SIH/PDPH - lumbar infusion test - pressure at tilt down
timeFrame: up to 4 weeks after inclusion
measure: SIH/PDPH - lumbar infusion test - pressure at tilt up 10°
timeFrame: up to 4 weeks after inclusion
measure: SIH/PDPH - lumbar infusion test - pressure at tilt up 30°
timeFrame: up to 4 weeks after inclusion
measure: SIH/PDPH - lumbar infusion test - pressure at plateau
timeFrame: up to 4 weeks after inclusion
measure: SIH/PDPH - Laboratory parameters at diagnosis (decriptive)
timeFrame: up to 4 weeks after inclusion
measure: SIH/PDPH - Lumbar Infusiontest - amplitude at baseline
timeFrame: up to 4 weeks
measure: SIH/PDPH - lumbar infusion test - amplitude at tilt down
timeFrame: up to 4 weeks after inclusion
measure: SIH/PDPH - lumbar infusion test -amplitude at tilt up 10°
timeFrame: up to 4 weeks after inclusion
measure: SIH/PDPH - lumbar infusion test - amplitude at tilt up 30°
timeFrame: up to 4 weeks after inclusion
measure: SIH/PDPH - lumbar infusion test - amplitude at plateau
timeFrame: up to 4 weeks after inclusion
measure: SIH/PDPH - PET-CT if performed -
timeFrame: up tp 4 weeks
measure: SIH/PDPH - Results of neuropathological tissue analysis if assessed (descriptive)
timeFrame: up to 6 weeks
measure: SIH/PDPH - phase-contrast MRI : CSF-velocity
timeFrame: up to 4 weeks
measure: SIH/PDPH - phase-contrast MRI: Stroke-volume CSF
timeFrame: up to 4 weeks
measure: SIH/PDPH - phase-contrast MRI: Spinal cord motion
timeFrame: up to 4 weeks
measure: SIH/PDPH - phase-contrast MRI: Spinal cord velocities
timeFrame: up to 4 weeks
measure: SIH/PDPH - MRI spine: Bud-on-branching sign (yes/no)
timeFrame: up to 4 weeks
measure: SIH/PDPH - MRI spine: Localized flow-voids in sagittal spine T2 images (yes/no)
timeFrame: up to 4 weeks
Other outcomes:
measure: SIH/PDPH - Follow up-Reported adverse events related to treatment (yes/no)
timeFrame: 4 weeks and 3 month after treatment
measure: SIH/PDPH - Follow up-Duration of treatment for rebound hypertension after therapy of the CSF leak
timeFrame: 4 weeks after treatment
measure: SIH/PDPH - Follow up-Average dosage of acetazolamide per day
timeFrame: 4 weeks after treatment
measure: SIH/PDPH - Follow up - Total Bern-Score, according to Dobrocky et al.
timeFrame: 3 months after treatment
measure: SIH/PDPH - Follow up - Subitems Bern-Score, according to Dobrocky et al.
timeFrame: 3 months after treatment
measure: SIH/PDPH - Follow up - Spinal longitudinal extradural fluid collection at site of the leak (SLEC) (only if present before)
timeFrame: 3 months after treatment
measure: SIH/PDPH - Follow up - Headache-Impact-Test (HIT)-6
timeFrame: 3, 6, 12 & 24 months after treatment
measure: SIH/PDPH - Follow up - 5 dimension/ 5 levels European Quality of life questionnaire (EQ-5D-5L)
timeFrame: 3, 6, 12, & 24 months after treatment
measure: SIH/PDPH - Follow up - Patient's Global Impression of Change (PGIC)
timeFrame: 3, 6, 12 & 24 months after treatment
measure: SIH/ PDPH - Follow up - Self-administered comorbidity questionnaire (SCQ)
timeFrame: 12 & 24 months after treatment
measure: SIH/PDPH - follow-up - current working capacity
timeFrame: at 4 weeks & 3, 6, 12 & 24 months
measure: SIH/PDPH - follow-up - complaints
timeFrame: 4 week, 3, 6, 12 & 24 months
measure: SIH/PDPH - follow-up - headache severity
timeFrame: 4 week, 3, 6, 12 & 24 months
measure: SIH/PDPH - follow-up - Days within the last month
timeFrame: 4 weeks, 3, 6, 12, 24 months
measure: SIH/PDPH - follow-up - maximum duration being continuously upright
timeFrame: 4 weeks, 3, 6, 12 & 24 months
measure: SIH/PDPH - follow-up - severeness of dizziness
timeFrame: 4 weeks, 3, 6, 12 &24 months
measure: SIH/PDPH - follow-up - Severeness of shoulder- and neck pain
timeFrame: 4 weeks, 3, 6, 12 & 24 months
measure: SIH/PDPH - follow-up - severeness of nausea
timeFrame: 4 weeks, 3, 6, 12 & 24 months
measure: SIH/PDPH - follow-up - severeness of hearing disturbances and tinnitus
timeFrame: 4 weeks, 3, 6, 12 & 24 months
measure: SIH/PDPH - follow-up - severeness of cognitive deficits
timeFrame: 4 weeks, 3, 6, 12 & 24 months
measure: SIH/PDPH - follow-up - severeness of visual disturbances
timeFrame: 4 weeks, 3, 6, 12 & 24 months
measure: SIH/PDPH - follow-up - exhaustion
timeFrame: 4 weeks, 3, 6,12 &24 months
measure: SIH/PDPH - follow-up - ability to focus and concentrate
timeFrame: 4 weeks, 3, 6, 12 & 24 months
measure: SIH/PDPH - follow-up - phase-contrast MRI: CSF-velocity (if performed)
timeFrame: up to 6 months after treatment
measure: SIH/PDPH - follow-up - phase-contrast MRI Stroke-volume CSF (if performed)
timeFrame: up to 6 months after treatment
measure: SIH/PDPH - follow-up - phase-contrast MRI Spinal cord motion (if performed)
timeFrame: up to 6 months after treatment
measure: SIH/PDPH - follow-up - phase-contrast MRI Spinal cord velocity (if performed)
timeFrame: up to 6 months after treatment
Locations:
city: Freiburg
country: Germany
facility: Medical Center - University of Freiburg, Germany
Study officials:
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