NCT02510742

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

July 22, 2015

Last Update Submit

July 31, 2022

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

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

    0-90 min

Study Arms (2)

SPG neurostimulation

ACTIVE COMPARATOR

SPG neurostimulation of frequency 20 Hz

Device: Neurostimulation

Control

SHAM COMPARATOR

Sham neurostimulation of amplitude=0

Device: Sham stimulation

Interventions

NeurostimulationDEVICE

Neurostimulation of sphenopalatine ganglion (SPG) of 20 Hz

SPG neurostimulation
Sham stimulationDEVICE

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

Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic migraine patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center

Copenhagen, Glostrup, 2600, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 32321288DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD student

Study Record Dates

First Submitted

July 22, 2015

First Posted

July 29, 2015

Study Start

July 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

August 2, 2022

Record last verified: 2022-07

Locations

DK(1)