Physiological Changes With SPG Stimulation in Migraine Patients

Not Applicable

Completed

• Conditions: Chronic Migraine
• Interventions: Device: Neurostimulation; Device: Sham stimulation

• Registration Number: NCT02510742
• Lead Sponsor: Danish Headache Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-29
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-31
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Chronic migraine patients

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SPG neurostimulation	Neurostimulation	SPG neurostimulation of frequency 20 Hz
Control	Sham stimulation	Sham neurostimulation of amplitude=0

Primary Outcome Measures

Name	Time	Method
Changes of mean blood velocity of middle cerebral artery (VMCA) using transcranial Doppler upon low frequency SPG stimulation	0-90 min

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Copenhagen, Glostrup, Denmark