Status:
COMPLETED
Spontaneous Intracranial Hypotension Treatment "SIHT"
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Spontaneous Intracranial Hypotension
Eligibility:
All Genders
18+ years
Phase:
NA
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 demonstr...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2021
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT02261792
Start Date
December 1 2014
End Date
March 8 2021
Last Update
April 21 2022
Active Locations (1)
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1
Lariboisiere Hospital - Centre Urgences Céphalées (CUC)
Paris, France, 75010