CompletedNot Applicable

Spontaneous Intracranial Hypotension Treatment "SIHT"

France64 participantsStarted 2014-12

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Recovery at Day 1 without relapse at Day 15

Timeframe: Day 1

Recovery at Day 1 without relapse at Day 15

Timeframe: day 15

Trial details

NCT IDNCT02261792

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10

View on ClinicalTrials.gov More Spontaneous Intracranial Hypotension trials