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Physiological Changes With SPG Stimulation in Migraine Patients

Primary Purpose

Chronic Migraine

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Neurostimulation
Sham stimulation
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Migraine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic migraine patients

Exclusion Criteria:

-

Sites / Locations

  • Danish Headache Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

SPG neurostimulation

Control

Arm Description

SPG neurostimulation of frequency 20 Hz

Sham neurostimulation of amplitude=0

Outcomes

Primary Outcome Measures

Changes of mean blood velocity of middle cerebral artery (VMCA) using transcranial Doppler upon low frequency SPG stimulation

Secondary Outcome Measures

Full Information

First Posted
July 22, 2015
Last Updated
July 31, 2022
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT02510742
Brief Title
Physiological Changes With SPG Stimulation in Migraine Patients
Official Title
Physiological Changes Induced With SPG Stimulation in Migraine Patients - Amendment to the Pathway M-1 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPG neurostimulation
Arm Type
Active Comparator
Arm Description
SPG neurostimulation of frequency 20 Hz
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham neurostimulation of amplitude=0
Intervention Type
Device
Intervention Name(s)
Neurostimulation
Intervention Description
Neurostimulation of sphenopalatine ganglion (SPG) of 20 Hz
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
Sham stimulation of sphenopalatine ganglion (SPG) with amplitude=0
Primary Outcome Measure Information:
Title
Changes of mean blood velocity of middle cerebral artery (VMCA) using transcranial Doppler upon low frequency SPG stimulation
Time Frame
0-90 min

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic migraine patients Exclusion Criteria: -
Facility Information:
Facility Name
Danish Headache Center
City
Copenhagen
State/Province
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
32321288
Citation
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.
Results Reference
derived

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Physiological Changes With SPG Stimulation in Migraine Patients

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