Intracranial Pressure in Experimental Models of Headache

Bangor University

Status: Completed

Conditions: High Altitude Headache

Treatments: Drug: Acetazolamide; Drug: Lactose monohydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01288781

F002686

2010-019520-31 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether increased pressure in the head is elevated in people who suffer from High Altitude Headache. We hypothesise that head pressure will be elevated in people with High Altitude Headache.

Full description

High Altitude Headache is the primary symptom of Acute Mountain Sickness. However, at present the reason why some individuals suffer from High Altitude Headache and others do not remains unknown. It is widely believed that elevated pressure within the brain leads to stretching of pain sensitive fibres and thus headache. However, evidence of raised intracranial pressure during High Altitude Headache is currently unavailable. Therefore, this study aims to examine a proxy measure of intracranial pressure (Optic Nerve Sheath Diameter) in persons visiting High Altitude, half of whom have been given the drug acetazolamide that is known to reduce headache symptoms.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Member of the Italian High Altitude Research Expeditions

Exclusion criteria

• Are under the age of 18years;
• sulfonamide allergy
• Liver or kidney disfunction
• Have any other uncontrolled medical condition
• Or are unable to give consent.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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23 participants in 2 patient groups, including a placebo group

Acetazolamide

Experimental group

Description:

Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).

Treatment:

Drug: Acetazolamide

Placebo

Placebo Comparator group

Description:

Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).

Treatment:

Drug: Lactose monohydrate