SPG Neurostimulation in Cluster Patients

August 14, 2017 updated by: Song Guo, Danish Headache Center

Sphenopalataine Ganglion (SPG) Stimulation in Cluster Headache Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Glostrup
      • Copenhagen, Glostrup, Denmark, 2600
        • Danish Headache Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic cluster patients

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SPG neurostimulation
Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz
Device: Neurostimulation
Placebo Comparator: Sham Stimulation
Sham stimulation with amplitude=0
Device: Sham stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-60 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical detection and pain thresholds
Time Frame: 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.
0-60 min
Plasma concentrations of PACAP38 and VIP
Time Frame: 0-60 min
Difference in plasma concentrations of PACAP38 and VIP between LF and sham stimulation.
0-60 min
Cardiac autonomic regulation (HRV)
Time Frame: 0-60 min
Changes in cardiac autonomic regulation (HRV) between LF and sham stimulation and during cluster attacks measured by continious ECG.
0-60 min
Mean arterial blood pressure and heart rate
Time Frame: 0-60 min
Difference in mean arterial blood pressure and heart rate between LF and sham stimulation.
0-60 min
Headache intensity
Time Frame: 0-60 min
Difference in headache intensity measured by numerical rating scale (NRS 0-10) between LF and sham stimulation.
0-60 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

July 22, 2015

First Submitted That Met QC Criteria

July 28, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15005609

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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