The Identification and Characterization of Autonomic Dysfunction in Migraineurs With and Without Auras

NeuroTherapia, Inc.

Status: Completed

Conditions: Migraine

Study type: Observational

Funder types: Other

Identifiers

NCT01080287

08-778

Details and patient eligibility

About

This is a study to compare subject response and symptoms resulting from administration of three clinical assessments.

* The 3 assessments are

1. passive upright tilt table testing,
2. quantitative sudomotor axon reflex testing (QSART)and
3. punch biopsy.

The comparison of results will be from two subject groups:

• Group A, the migraine suffering patient with or without aura
• Group B, the migraine suffering patient with or without aura who has diagnosed orthostatic intolerance (i.e.,feeling dizzy or faint when making a body position change).

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18 to 65
• male or female
• migraine diagnosis
• may or may not have orthostatic intolerance
• able to demonstrate study understanding and complete informed consent process

Exclusion criteria

• subjects who do not meet inclusion criteria
• subjects unable to complete informed consent process

Trial design

60 participants in 2 patient groups

Migraineurs with & w/out auras having orthostatic intolerance

Description:

Subjects between ages 18 and 65, having ICHD-II classification of migraine with or without aura, having symptoms of orthostatic intolerance

Migraineurs with or without auras

Description:

Subjects between ages 18 and 65 having ICHD-II classification of migraine with or without auras