An interventional study of Neurostimulation and Sham stimulation in Chronic Cluster Headache, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2017-08-16.
Sponsored by Danish Headache Center · Not applicable, Interventional, and Other
We hypothesized that LF stimulation of the SPG would increase parasympathetic outflow, activate sensory afferents and provoke a cluster-like attack.
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.
116 studies on the registry are indexed under Cluster Headache; 27 are open to participants now.
This study's enrollment of 21 is below the median of 42 across 86 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →Danish Headache Center is the lead sponsor of 125 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
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Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz
Device: Neurostimulation
Sham stimulation with amplitude=0
Device: Sham stimulation
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.
Time frame: 0-60 min
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.
Time frame: 0-60 min
Plasma concentrations of PACAP38 and VIP
Difference in plasma concentrations of PACAP38 and VIP between LF and sham stimulation.
Time frame: 0-60 min
Cardiac autonomic regulation (HRV)
Changes in cardiac autonomic regulation (HRV) between LF and sham stimulation and during cluster attacks measured by continious ECG.
Time frame: 0-60 min
Mean arterial blood pressure and heart rate
Difference in mean arterial blood pressure and heart rate between LF and sham stimulation.
Time frame: 0-60 min
Headache intensity
Difference in headache intensity measured by numerical rating scale (NRS 0-10) between LF and sham stimulation.
Time frame: 0-60 min
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Danish Headache Center