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

Brief Title

Spontaneous Intracranial Hypotension Treatment "SIHT"

Official Title

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

Brief Summary

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

Detailed Description

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

1. EBP with 24 hours bed rest

2. 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

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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