Spontaneous Intracranial Hypotension Treatment "SIHT"

Not Applicable

Completed

• Conditions: Spontaneous Intracranial Hypotension
• Interventions: Procedure: 24 hours bed rest; Procedure: 24 hours Trendelenburg position; Procedure: EBP

• Registration Number: NCT02261792
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-10
• Study Start: 2014-12
• Primary Completion: 2020-10
• Study Completion: 2021-03-08
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A : 24 hours bed rest	24 hours bed rest	24 hours bed rest
B : 24 hours Trendelenburg position	24 hours Trendelenburg position	24 hours Trendelenburg position
A : 24 hours bed rest	EBP	24 hours bed rest
B : 24 hours Trendelenburg position	EBP	24 hours Trendelenburg position

Primary Outcome Measures

Name	Time	Method
Recovery at Day 1 without relapse at Day 15	day 15	V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety)

Secondary Outcome Measures

Name	Time	Method
medullar MRI	day 60	results of baseline medullar MRI and the link between leak and patient recovery
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)
subdural hematoma surgery	day 7, 15, 30 and 60	Number of patients requires a surgery for life-threatening acute SDH
Epidural Blood Patch	day 60	Volume of blood and localisation of injection / statistical data related with recovery
cerebral MRI	day 30	results of D30 control MRI, compared to baseline MRI
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

Trial Locations

Locations (1)

Lariboisiere Hospital - Centre Urgences Céphalées (CUC); 🇫🇷 Paris, France