Spontaneous Intracranial Hypotension Treatment SIHT

Study Overview
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Brief Summary
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Spontaneous intracranial hypotension (SIH) is an infrequent disease, related to a leak of cerebrospinal fluid. There are not controlled studies for this treatment.The main of this study is to demonstrate the superiority of the Trendelenburg position compared to supine position during 24 hours after an epidural blood patch for a spontaneous intracranial hypotension

Detailed Description
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Various treatments have been used for patient with spontaneous intracranial hypotension, but there is not definite approach. Some patients, fortunately, improve spontaneously. Bed rest and increased fluid intake have been advocate. The effectiveness of the caffeine has been shown in some studies, but durable beneficial effect is doubtful. The efficacy of steroids has not been established. However, although there have been no controlled studies, autologous epidural blood patch (EBP) can be considered the treatment of choice for patients. The success rate of EBP for a post lumbar puncture headache is about 90%, but for SIH, is very less about 50% after the first one and 77% after the second. The amount of blood injected must be sufficient. On the other hand, the leak is usually located on dorsal, above the prolonged rest must be respected. One study, have demonstrated, without randomization, a success rate of 90% with a prolonged Trendelenburg after EBP. We decided to do this study, to confirm a superiority of a 24 hours prolonged Trendelenburg position. It's a monocentric study of parallel randomized open blind groups. Patients will be recruited by investigators in our headache emergency room. If the diagnose of SIH is confirmed (orthostatic headache from more than 5 days and less than 28 days with a normal MRI or with sign of SIH) study will be proposed. After a signed information, the patients will be randomized in 2 groups, the investigator is blind of the randomized arm of patient EBP with 24 hours bed rest EBP with 24 hours Trendelenburg position V1: inclusion V2 : 24 hours before EBP (headache, associated symptoms, HIT6) V3 : randomization and EBP V4 : first evaluation 30 minutes after standing (headaches, associated symptoms) V5 : phone evaluation (safety) D7 V6 : Evaluation at D15 (headache, associated symptoms, safety) V7 : Evaluation at D30 (headache, associated symptoms, control cerebral MRI, HIT6, safety) V8 : last evaluation D60 (headache, associated symptoms,HIT6 safety) Collection of 2nd EBP, 3rd EBP, 4th EBP throughout the study up to J 92 maximum

Official Title
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Parallel Randomised Open Blind Evaluation Study of the Efficacy of 20° Trendelenburg Position During 24 Hours After Epidural Blood Patch in the Treatment of Spontaneous Intracranial Hypotension

Conditions
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Spontaneous Intracranial Hypotension

Intervention / Treatment
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* Procedure: 24 hours Trendelenburg position
* Procedure: 24 hours bed rest
* Procedure: EBP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or more No contraindication for BPE Severe or moderate headache within 15 min standing, mild or no headache after 15 min bed rest Headache from 5 to 28 days Normal or evidence of low CSF on MRI Signed informed consent Exclusion Criteria: Known dural leak in the previous 2 months the onset of headache Abnormal MRI First BPE for SIH The patient has participated in another clinical trial than can interact with the evaluation Contraindication of Trendelenburg position

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A : 24 hours bed rest<br>24 hours bed rest | Procedure: 24 hours bed rest<br>* 24 hours bed rest after EBP<br>* Other names: Allitement flat position for 24 hours;Procedure: EBP<br>* Autologous Epidural Blood Patch<br>* Other names: Epidural Blood Patch;|
| Experimental: B : 24 hours Trendelenburg position<br>24 hours Trendelenburg position | Procedure: 24 hours Trendelenburg position<br>* Trendelenburg position<br>* Other names: inclination of the body at 20 degrees;Procedure: EBP<br>* Autologous Epidural Blood Patch<br>* Other names: Epidural Blood Patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery at Day 1 without relapse at Day 15 | V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety) | Day 1 | 
| Recovery at Day 1 without relapse at Day 15 | V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety) | day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2d EBP and other EBP | Number of patients requires a treatment with a second BP at any time of study (withdrawal study) | day 7, 15, 30 and 60 | 
| Associated symptoms | Disappearance of associated symptoms | day 1, 15, 30 and 60 | 
| Headache | Pain scores, localisation and type of persistent headache at day 1,15, 30 and 60 | day 1,15, 30 and 60 | 
| subdural hematoma surgery | Number of patients requires a surgery for life-threatening acute SDH | day 7, 15, 30 and 60 | 
| cerebral MRI | results of D30 control MRI, compared to baseline MRI | day 30 | 
| medullar MRI | results of baseline medullar MRI and the link between leak and patient recovery | day 60 | 
| Epidural Blood Patch | Volume of blood and localisation of injection / statistical data related with recovery | day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postural headache treatment, Spontaneous intracranial hypotension, Epidural blood patch, Trendelenburg position, Head-Down Tilt, Blood Patch, Epidural