Spontaneous Intracranial Hypotension
Conditions
Keywords
Postural headache treatment, Spontaneous intracranial hypotension, Epidural blood patch, Trendelenburg position, Head-Down Tilt, Blood Patch, Epidural
Brief summary
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
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
Interventions
PROCEDURE24 hours Trendelenburg position
Trendelenburg position
PROCEDURE24 hours bed rest
24 hours bed rest after EBP
PROCEDUREEBP
Autologous Epidural Blood Patch
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery at Day 1 without relapse at Day 15 | Day 1 | V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epidural Blood Patch | day 60 | Volume of blood and localisation of injection / statistical data related with recovery |
| subdural hematoma surgery | day 7, 15, 30 and 60 | Number of patients requires a surgery for life-threatening acute SDH |
| cerebral MRI | day 30 | results of D30 control MRI, compared to baseline MRI |
| medullar MRI | day 60 | results of baseline medullar MRI and the link between leak and patient recovery |
| Associated symptoms | day 1, 15, 30 and 60 | Disappearance of associated symptoms |
| Headache | day 1,15, 30 and 60 | Pain scores, localisation and type of persistent headache at day 1,15, 30 and 60 |
| 2d EBP and other EBP | day 7, 15, 30 and 60 | Number of patients requires a treatment with a second BP at any time of study (withdrawal study) |
Countries
France
Outcome results
None listed