NCT02510729

Brief Summary

We hypothesized that LF stimulation of the SPG would increase parasympathetic outflow, activate sensory afferents and provoke a cluster-like attack.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

July 22, 2015

Last Update Submit

August 14, 2017

Conditions

Chronic Cluster Headache

Outcome Measures

Primary Outcomes (1)

  • Incidence of cluster-like attacks and cephalic autonomic symptoms

    Difference in incidence of cluster-like attacks and cephalic autonomic symptoms between LF and sham stimulation.

    0-60 min

Secondary Outcomes (5)

  • Mechanical detection and pain thresholds

    0-60 min

  • Plasma concentrations of PACAP38 and VIP

    0-60 min

  • Cardiac autonomic regulation (HRV)

    0-60 min

  • Mean arterial blood pressure and heart rate

    0-60 min

  • Headache intensity

    0-60 min

Study Arms (2)

SPG neurostimulation

ACTIVE COMPARATOR

Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz

Device: Neurostimulation

Sham Stimulation

PLACEBO COMPARATOR

Sham stimulation with amplitude=0

Device: Sham stimulation

Interventions

NeurostimulationDEVICE
SPG neurostimulation
Sham stimulationDEVICE
Sham Stimulation

Eligibility Criteria

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

You may qualify if:

  • Chronic cluster 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, Petersen AS, Schytz HW, Barlose M, Caparso A, Fahrenkrug J, Jensen RH, Ashina M. Cranial parasympathetic activation induces autonomic symptoms but no cluster headache attacks. Cephalalgia. 2018 Jul;38(8):1418-1428. doi: 10.1177/0333102417738250. Epub 2017 Oct 30.

    PMID: 29082824DERIVED

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Messoud Ashina, Prof.

    Danish Headache Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
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

May 1, 2016

Study Completion

October 1, 2016

Last Updated

August 16, 2017

Record last verified: 2017-08

Locations

DK(1)