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Clinical Trials/NCT02510729
NCT02510729CompletedNot Applicable

Sphenopalataine Ganglion (SPG) Stimulation in Cluster Headache Patients

Danish Headache Center1 site in 1 country21 target enrollmentStarted: July 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Incidence of cluster-like attacks and cephalic autonomic symptoms

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Chronic cluster patients

Exclusion Criteria

  • Not provided

Arms & Interventions

SPG neurostimulation

Active Comparator

Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz

Intervention: Neurostimulation (Device)

Sham Stimulation

Placebo Comparator

Sham stimulation with amplitude=0

Intervention: Sham stimulation (Device)

Outcomes

Primary Outcomes

Incidence of cluster-like attacks and cephalic autonomic symptoms

Time Frame: 0-60 min

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

Secondary Outcomes

  • Plasma concentrations of PACAP38 and VIP(0-60 min)
  • Mean arterial blood pressure and heart rate(0-60 min)
  • Cardiac autonomic regulation (HRV)(0-60 min)
  • Mechanical detection and pain thresholds(0-60 min)
  • Headache intensity(0-60 min)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Song Guo

MD, PhD student

Danish Headache Center

Study Sites (1)

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