Back to resultsSPG Neurostimulation in Cluster Patients
Primary Purpose
Chronic Cluster Headache
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Neurostimulation
Sham stimulation
Sponsored by
About this trial
This is an interventional other trial for Chronic Cluster Headache
Eligibility Criteria
Inclusion Criteria:
- Chronic cluster patients
Exclusion Criteria:
-
Sites / Locations
- Danish Headache Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
SPG neurostimulation
Sham Stimulation
Arm Description
Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz
Sham stimulation with amplitude=0
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Mechanical detection and pain thresholds
Difference in mechanical detection and pain thresholds in the face between LF and sham stimulation measured by pin-prick and von Frey hairs.
Plasma concentrations of PACAP38 and VIP
Difference in plasma concentrations of PACAP38 and VIP between LF and sham stimulation.
Cardiac autonomic regulation (HRV)
Changes in cardiac autonomic regulation (HRV) between LF and sham stimulation and during cluster attacks measured by continious ECG.
Mean arterial blood pressure and heart rate
Difference in mean arterial blood pressure and heart rate between LF and sham stimulation.
Headache intensity
Difference in headache intensity measured by numerical rating scale (NRS 0-10) between LF and sham stimulation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02510729
Brief Title
SPG Neurostimulation in Cluster Patients
Official Title
Sphenopalataine Ganglion (SPG) Stimulation in Cluster Headache Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We hypothesized that LF stimulation of the SPG would increase parasympathetic outflow, activate sensory afferents and provoke a cluster-like attack.
Detailed Description
We conducted a double-blind, randomized, sham-controlled, crossover study to investigate cluster attack induction following LF (20 Hz and 0.2-2.1 amplitude) and sham (amplitude = 0) stimulation in 20 CH patients with implanted SPG neurostimulator. In addition, we measured plasma concentrations of pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal peptide (VIP), as markers for parasympathetic activation before, during and after SPG stimulation. We also investigated if LF SPG stimulation induces changes in cardiac autonomic regulation and whether any attacks induced by SPG stimulation are associated with such changes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cluster Headache
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPG neurostimulation
Arm Type
Active Comparator
Arm Description
Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz
Arm Title
Sham Stimulation
Arm Type
Placebo Comparator
Arm Description
Sham stimulation with amplitude=0
Intervention Type
Device
Intervention Name(s)
Neurostimulation
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Primary Outcome Measure Information:
Title
Incidence of cluster-like attacks and cephalic autonomic symptoms
Description
Difference in incidence of cluster-like attacks and cephalic autonomic symptoms between LF and sham stimulation.
Time Frame
0-60 min
Secondary Outcome Measure Information:
Title
Mechanical detection and pain thresholds
Description
Difference in mechanical detection and pain thresholds in the face between LF and sham stimulation measured by pin-prick and von Frey hairs.
Time Frame
0-60 min
Title
Plasma concentrations of PACAP38 and VIP
Description
Difference in plasma concentrations of PACAP38 and VIP between LF and sham stimulation.
Time Frame
0-60 min
Title
Cardiac autonomic regulation (HRV)
Description
Changes in cardiac autonomic regulation (HRV) between LF and sham stimulation and during cluster attacks measured by continious ECG.
Time Frame
0-60 min
Title
Mean arterial blood pressure and heart rate
Description
Difference in mean arterial blood pressure and heart rate between LF and sham stimulation.
Time Frame
0-60 min
Title
Headache intensity
Description
Difference in headache intensity measured by numerical rating scale (NRS 0-10) between LF and sham stimulation.
Time Frame
0-60 min
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic cluster patients
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, Prof.
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
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
29082824
Citation
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.
Results Reference
derived
Learn more about this trial
SPG Neurostimulation in Cluster Patients
We'll reach out to this number within 24 hrs