Sphenopalataine Ganglion (SPG) Stimulation in Cluster Headache Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Danish Headache Center
- 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
Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz
Intervention: Neurostimulation (Device)
Sham Stimulation
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
Song Guo
MD, PhD student
Danish Headache Center