MRI contrast agent in the spinal canal to investigate transportation of the cerebrospinal fluid in the brain.

Phase 1

• Conditions: Cerebrospinal fluid circulation disorder seen in clinically suspected idiopathic normal pressure hydrocephalus; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-005542-42-SE
• Lead Sponsor: Region Västerbotten

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-25
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients investigated for suspected idiopathic normal pressure hydrocephalus at Umeå University Hospital
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Age < 65
Known contradicting allergies
Known contraindications for magnetic resonance imaging
Renal impairment (as deffined by blood test at admission)
Current treatment with anticoagulation medication
Low threshold to seizures
History of bronchial asthma
Previous investigation with gadolinium contrast medium
Mini Mental State Examination (MMSE) <18
Not able to understand instructions needed for informed concent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified