Comorbidities Associated With Migraine and Patent Foramen Ovale (CAMP) (CAMP)

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Over a 20-month period (January 2010 to May 2011), 127 subjects were screened and 31 were enrolled from Swedish Medical Center and the University of Washington Medical Center, including 19 with MA + PFO and 12 with MA – PFO.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 127 potential subjects screened, reasons for exclusion included the following: 22 (17%) chronic migraine or medication overuse headache; 9 (7%) topiramate use; 6 (5%) stroke or multiple sclerosis; 39 (31%) other (declined, low frequency); 12 (9%) small to medium sized PFO; 8 (6%) fetal origins.

Reporting Groups

	Description
Control (Absence of PFO)	Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
Large PFO	Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.

Participant Flow:   Overall Study

	Control (Absence of PFO)	Large PFO
STARTED	12	19
COMPLETED	12	19
NOT COMPLETED	0	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Control (Absence of PFO)	Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
Large PFO	Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
Total	Total of all reporting groups

Baseline Measures

	Control (Absence of PFO)	Large PFO	Total
Overall Participants Analyzed  [Units: Participants]	12	19	31
Age  [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	12	19	31
>=65 years	0	0	0
Age  [Units: Years] Mean (Standard Deviation)	37  (10)	35  (11)	35  (11)
Gender  [Units: Participants]
Female	11	16	27
Male	1	3	4
Region of Enrollment  [Units: Participants]
United States	12	19	31

1.  Primary:

Cerebral Vasomotor Reactivity (VMR)   [ Time Frame: Baseline ]

2.  Primary:

Sleep Apnea, Number of Participants   [ Time Frame: Following one night of a home sleep study ]

3.  Primary:

Embolic Tracks   [ Time Frame: Baseline ]

4.  Primary:

Platelet Activation   [ Time Frame: Baseline ]

5.  Primary:

Cognitive Function   [ Time Frame: Baseline ]

6.  Secondary:

Oxygen Desaturation Index   [ Time Frame: Baseline ]

7.  Secondary:

White Matter Lesions   [ Time Frame: Within 5 years prior to enrollment ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Subjects were recruited from a headache clinic and had a high degree of migraine burden; thus, the sample may not accurately represent the general migraine population. The number of men in the sample was insufficient to test sex differences.