NCT02510729

SPG Neurostimulation in Cluster Patients

Sphenopalataine Ganglion (SPG) Stimulation in Cluster Headache Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Danish Headache Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Cluster Headache

Interventions

Type	Name	Description
DEVICE	Neurostimulation
DEVICE	Sham stimulation

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-05-01
• Completion: 2016-10-01
• First posted: 2015-07-29
• Last updated: 2017-08-16

Locations

1 site across 1 country: Denmark