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NCT02510742 Clinical Trial

Physiological Changes With SPG Stimulation in Migraine Patients

Chronic Migraine Clinical Trial

Official title:
Physiological Changes Induced With SPG Stimulation in Migraine Patients - Amendment to the Pathway M-1 Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02510742
Other study ID # H-1-2011-152
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2015
Est. completion date February 2016

Study information
Verified date July 2022
Source Danish Headache Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hypothesis: Stimulation of the SPG at low frequencies (20 Hz)is believed to cause a physiological parasympathetic upregulation which increases VMCA, concentration and cephalic vessel diameter.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Chronic migraine patients Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Neurostimulation
Neurostimulation of sphenopalatine ganglion (SPG) of 20 Hz
• Sham stimulation
Sham stimulation of sphenopalatine ganglion (SPG) with amplitude=0

Locations
Country Name City State
Denmark Danish Headache Center Copenhagen Glostrup

Sponsors (1)
Lead Sponsor Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes of mean blood velocity of middle cerebral artery (VMCA) using transcranial Doppler upon low frequency SPG stimulation 0-90 min
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