The Freiburg Registry on SpontanEous IntercrAnial Hypotension (SIH) & Post-duraL Puncture Headache (PDPH)
NCT ID: NCT06711731
Last Updated: 2024-12-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
2000 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-11-04
Study Completion Date
2036-12-04
Brief Summary
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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.
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
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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.
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.
Conditions
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CerebroSpinal Fluid (CSF) Leak
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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spinal CSF leak
Patients with suspected spinal CSF leak based on one of the following:
1. History of new orthostatic symptoms with or without prior spinal procedure
2. Imaging suggestive for spinal CSF leak
No interventions assigned to this group
Eligibility Criteria
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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
* 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
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital Freiburg
OTHER
Sponsor Role
lead
Responsible Party
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Myriam Peters
Scientist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Medical Center - University of Freiburg, Germany
Freiburg im Breisgau, , Germany
Site Status
RECRUITING
Countries
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Germany
Central Contacts
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References
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Schievink WI, Maya MM, Moser FG, Simon P, Nuno M. Incidence of spontaneous intracranial hypotension in a community: Beverly Hills, California, 2006-2020. Cephalalgia. 2022 Apr;42(4-5):312-316. doi: 10.1177/03331024211048510. Epub 2021 Sep 23.
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Schievink WI, Maya M, Barnard Z, Tache RB, Prasad RS, Wadhwa VS, Moser FG, Nuno M. The reversible impairment of behavioral variant frontotemporal brain sagging syndrome: Challenges and opportunities. Alzheimers Dement (N Y). 2022 Dec 18;8(1):e12367. doi: 10.1002/trc2.12367. eCollection 2022.
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Schievink WI, Maya MM, Harris J, Galvan J, Tache RB, Nuno M. Infratentorial Superficial Siderosis and Spontaneous Intracranial Hypotension. Ann Neurol. 2023 Jan;93(1):64-75. doi: 10.1002/ana.26521. Epub 2022 Oct 22.
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Sprave T, Gkika E, Verma V, Grosu AL, Stoian R. Patient reported outcomes based on EQ-5D-5L questionnaires in head and neck cancer patients: a real-world study. BMC Cancer. 2022 Nov 29;22(1):1236. doi: 10.1186/s12885-022-10346-4.
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BACKGROUND
Niraj G, Mushambi M, Gauthama P, Patil A, Kelkar A, Hart E, Nurmikko T; Accidental Dural Puncture Outcome Study Collaborative Group. Persistent headache and low back pain after accidental dural puncture in the obstetric population: a prospective, observational, multicentre cohort study. Anaesthesia. 2021 Aug;76(8):1068-1076. doi: 10.1111/anae.15491. Epub 2021 Apr 23.
Reference Type
BACKGROUND
Ranganathan P, Golfeiz C, Phelps AL, Singh S, Shnol H, Paul N, Attaallah AF, Vallejo MC. Chronic headache and backache are long-term sequelae of unintentional dural puncture in the obstetric population. J Clin Anesth. 2015 May;27(3):201-6. doi: 10.1016/j.jclinane.2014.07.008. Epub 2014 Dec 4.
Reference Type
BACKGROUND
MacArthur C, Lewis M, Knox EG. Accidental dural puncture in obstetric patients and long term symptoms. BMJ. 1993 Apr 3;306(6882):883-5. doi: 10.1136/bmj.306.6882.883.
Reference Type
BACKGROUND
Piechowiak EI, Aeschimann B, Hani L, Kaesmacher J, Mordasini P, Jesse CM, Schankin CJ, Raabe A, Schar RT, Gralla J, Beck J, Dobrocky T. Epidural Blood Patching in Spontaneous Intracranial Hypotension-Do we Really Seal the Leak? Clin Neuroradiol. 2023 Mar;33(1):211-218. doi: 10.1007/s00062-022-01205-7. Epub 2022 Aug 26.
Reference Type
BACKGROUND
Beck J, Hubbe U, Klingler JH, Roelz R, Kraus LM, Volz F, Lutzen N, Urbach H, Kieselbach K, Fung C. Minimally invasive surgery for spinal cerebrospinal fluid leaks in spontaneous intracranial hypotension. J Neurosurg Spine. 2022 Sep 9;38(1):147-152. doi: 10.3171/2022.7.SPINE2252. Print 2023 Jan 1.
Reference Type
BACKGROUND
Carlton Jones L, Butteriss D, Scoffings D. Spontaneous intracranial hypotension: the role of radiology in diagnosis and management. Clin Radiol. 2022 Mar;77(3):e181-e194. doi: 10.1016/j.crad.2021.11.007. Epub 2021 Dec 20.
Reference Type
BACKGROUND
Dobrocky T, Grunder L, Breiding PS, Branca M, Limacher A, Mosimann PJ, Mordasini P, Zibold F, Haeni L, Jesse CM, Fung C, Raabe A, Ulrich CT, Gralla J, Beck J, Piechowiak EI. Assessing Spinal Cerebrospinal Fluid Leaks in Spontaneous Intracranial Hypotension With a Scoring System Based on Brain Magnetic Resonance Imaging Findings. JAMA Neurol. 2019 May 1;76(5):580-587. doi: 10.1001/jamaneurol.2018.4921.
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BACKGROUND
Pradeep A, Madhavan AA, Brinjikji W, Cutsforth-Gregory JK. Incidence of spontaneous intracranial hypotension in Olmsted County, Minnesota: 2019-2021. Interv Neuroradiol. 2025 Jun;31(3):364-368. doi: 10.1177/15910199231165429. Epub 2023 Mar 22.
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BACKGROUND
Farb RI, Nicholson PJ, Peng PW, Massicotte EM, Lay C, Krings T, terBrugge KG. Spontaneous Intracranial Hypotension: A Systematic Imaging Approach for CSF Leak Localization and Management Based on MRI and Digital Subtraction Myelography. AJNR Am J Neuroradiol. 2019 Apr;40(4):745-753. doi: 10.3174/ajnr.A6016. Epub 2019 Mar 28.
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BACKGROUND
Hani L, Fung C, El Rahal A, Volz F, Kraus LM, Schnell O, Ferrarese R, Erny D, Schwabenland M, Urbach H, Lutzen N, Beck J. Distinct Pattern of Membrane Formation With Spinal Cerebrospinal Fluid Leaks in Spontaneous Intracranial Hypotension. Oper Neurosurg. 2024 Jan 1;26(1):71-77. doi: 10.1227/ons.0000000000000914. Epub 2023 Sep 25.
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BACKGROUND
Uppal V, Russell R, Sondekoppam RV, Ansari J, Baber Z, Chen Y, DelPizzo K, Dirzu DS, Kalagara H, Kissoon NR, Kranz PG, Leffert L, Lim G, Lobo C, Lucas DN, Moka E, Rodriguez SE, Sehmbi H, Vallejo MC, Volk T, Narouze S. Evidence-based clinical practice guidelines on postdural puncture headache: a consensus report from a multisociety international working group. Reg Anesth Pain Med. 2024 Jul 8;49(7):471-501. doi: 10.1136/rapm-2023-104817.
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BACKGROUND
Jesse CM, Hani L, Fung C, Ulrich CT, Schar RT, Dobrocky T, Piechowiak EI, Goldberg J, Schankin C, Sintonen H, Beck J, Raabe A. The impact of spontaneous intracranial hypotension on social life and health-related quality of life. J Neurol. 2022 Oct;269(10):5466-5473. doi: 10.1007/s00415-022-11207-7. Epub 2022 Jun 14.
Reference Type
BACKGROUND
Beck J, Ulrich CT, Fung C, Fichtner J, Seidel K, Fiechter M, Hsieh K, Murek M, Bervini D, Meier N, Mono ML, Mordasini P, Hewer E, Z'Graggen WJ, Gralla J, Raabe A. Diskogenic microspurs as a major cause of intractable spontaneous intracranial hypotension. Neurology. 2016 Sep 20;87(12):1220-6. doi: 10.1212/WNL.0000000000003122. Epub 2016 Aug 26.
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BACKGROUND
Kilic K, Korsbaek JJ, Jensen RH, Cvetkovic VV. Diagnosis of idiopathic intracranial hypertension - the importance of excluding secondary causes: A systematic review. Cephalalgia. 2022 May;42(6):524-541. doi: 10.1177/03331024211056580. Epub 2021 Nov 25.
Reference Type
BACKGROUND
Ducros A, Biousse V. Headache arising from idiopathic changes in CSF pressure. Lancet Neurol. 2015 Jun;14(6):655-68. doi: 10.1016/S1474-4422(15)00015-0.
Reference Type
BACKGROUND
Cheema S, Anderson J, Duncan C, Davagnanam I, Armstrong P, Redfern N, Ordman A, D'Antona L, Nissen J, Sayal P, Vaughan-Huxley E, Lagrata S, Iodice V, Snape-Burns J, Joy C, Matharu M. Survey of healthcare professionals' knowledge, attitudes and practices regarding spontaneous intracranial hypotension. BMJ Neurol Open. 2022 Sep 5;4(2):e000347. doi: 10.1136/bmjno-2022-000347. eCollection 2022.
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BACKGROUND
Cheema S, Joy C, Pople J, Snape-Burns J, Trevarthen T, Matharu M. Patient experience of diagnosis and management of spontaneous intracranial hypotension: a cross-sectional online survey. BMJ Open. 2022 Jan 20;12(1):e057438. doi: 10.1136/bmjopen-2021-057438.
Reference Type
BACKGROUND
Hani L, Fung C, Jesse CM, Ulrich CT, Piechowiak EI, Gralla J, Raabe A, Dobrocky T, Beck J. Outcome after surgical treatment of cerebrospinal fluid leaks in spontaneous intracranial hypotension-a matter of time. J Neurol. 2022 Mar;269(3):1439-1446. doi: 10.1007/s00415-021-10710-7. Epub 2021 Jul 18.
Reference Type
BACKGROUND
Volz F, Fung C, Wolf K, Lutzen N, Urbach H, Kraus LM, Omer M, Beck J, El Rahal A. Recovery and long-term outcome after neurosurgical closure of spinal CSF leaks in patients with spontaneous intracranial hypotension. Cephalalgia. 2023 Aug;43(8):3331024231196808. doi: 10.1177/03331024231195830.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
https://spinalcsfleak.org/
Spinal CSF Leak Foundation - Home - Spinal CSF Leak Foundation. Accessed September 5, 2023
https://csfleak.uk/
Homepage. CSF Leak Association. Accessed September 5, 2023
https://www.spinalcsfleakcanada.ca
SPINAL CSF LEAK CANADA. SPINAL CSF LEAK CANADA. Accessed September 5, 2023
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24-1357-S1
Identifier Type: -
Identifier Source: org_study_id