SPG Neurostimulation in Cluster Patients

Not Applicable

Completed

• Conditions: Chronic Cluster Headache
• Interventions: Device: Neurostimulation; Device: Sham stimulation

• Registration Number: NCT02510729
• Lead Sponsor: Danish Headache Center

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-29
• Primary Completion: 2016-05
• Study Completion: 2016-10
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Chronic cluster patients

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SPG neurostimulation	Neurostimulation	Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz
Sham Stimulation	Sham stimulation	Sham stimulation with amplitude=0

Primary Outcome Measures

Name	Time	Method
Incidence of cluster-like attacks and cephalic autonomic symptoms	0-60 min	Difference in incidence of cluster-like attacks and cephalic autonomic symptoms between LF and sham stimulation.

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of PACAP38 and VIP	0-60 min	Difference in plasma concentrations of PACAP38 and VIP between LF and sham stimulation.
Mean arterial blood pressure and heart rate	0-60 min	Difference in mean arterial blood pressure and heart rate between LF and sham stimulation.
Cardiac autonomic regulation (HRV)	0-60 min	Changes in cardiac autonomic regulation (HRV) between LF and sham stimulation and during cluster attacks measured by continious ECG.
Mechanical detection and pain thresholds	0-60 min	Difference in mechanical detection and pain thresholds in the face between LF and sham stimulation measured by pin-prick and von Frey hairs.
Headache intensity	0-60 min	Difference in headache intensity measured by numerical rating scale (NRS 0-10) between LF and sham stimulation.

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Copenhagen, Glostrup, Denmark