Physiological Changes With SPG Stimulation in Migraine Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02510742

Enrollment

Registered

2015-07-29

Start date

2015-07-31

Completion date

2016-02-29

Last updated

2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Migraine

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.

Interventions

DEVICENeurostimulation

Neurostimulation of sphenopalatine ganglion (SPG) of 20 Hz

DEVICESham stimulation

Sham stimulation of sphenopalatine ganglion (SPG) with amplitude=0

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Chronic migraine patients

Exclusion criteria

Design outcomes

Primary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026