Physiological Changes With SPG Stimulation in Migraine Patients

NCT ID: NCT02510742

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Migraine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SPG neurostimulation

SPG neurostimulation of frequency 20 Hz

Group Type ACTIVE_COMPARATOR

Neurostimulation

Intervention Type DEVICE

Neurostimulation of sphenopalatine ganglion (SPG) of 20 Hz

Control

Sham neurostimulation of amplitude=0

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neurostimulation

Neurostimulation of sphenopalatine ganglion (SPG) of 20 Hz

Intervention Type DEVICE

Sham stimulation

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Chronic migraine patients

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Song Guo

MD, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Danish Headache Center

Copenhagen, Glostrup, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

Guo S, Falkenberg K, Schytz HW, Caparso A, Jensen RH, Ashina M. Low frequency activation of the sphenopalatine ganglion does not induce migraine-like attacks in migraine patients. Cephalalgia. 2020 Aug;40(9):966-977. doi: 10.1177/0333102420921156. Epub 2020 Apr 22.

Reference Type DERIVED
PMID: 32321288 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-1-2011-152

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.