SPG Neurostimulation in Cluster Patients

Chronic Cluster Headache Clinical Trial

Official title:

Sphenopalataine Ganglion (SPG) Stimulation in Cluster Headache Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510729
• Other study ID #: H-15005609
• Status: Completed
• Phase: N/A
• First received: July 22, 2015
• Last updated: August 14, 2017
• Start date: July 2015
• Est. completion date: October 2016

Study information

• Verified date: August 2017
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We hypothesized that LF stimulation of the SPG would increase parasympathetic outflow, activate sensory afferents and provoke a cluster-like attack.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Chronic cluster patients

Exclusion Criteria:

Related Conditions & MeSH terms

• Chronic Cluster Headache
• Cluster Headache
• Headache

Intervention

Device:
• Neurostimulation

• Sham stimulation

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0-60 min
Secondary	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.	0-60 min
Secondary	Plasma concentrations of PACAP38 and VIP	Difference in plasma concentrations of PACAP38 and VIP between LF and sham stimulation.	0-60 min
Secondary	Cardiac autonomic regulation (HRV)	Changes in cardiac autonomic regulation (HRV) between LF and sham stimulation and during cluster attacks measured by continious ECG.	0-60 min
Secondary	Mean arterial blood pressure and heart rate	Difference in mean arterial blood pressure and heart rate between LF and sham stimulation.	0-60 min
Secondary	Headache intensity	Difference in headache intensity measured by numerical rating scale (NRS 0-10) between LF and sham stimulation.	0-60 min