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Completed

NCT Number: NCT02510729

SPG Neurostimulation in Cluster Patients

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

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Key information

Conditions

Chronic Cluster Headache Brain Diseases Central Nervous System Diseases Cluster Headache Headache Disorders Headache Disorders, Primary Nervous System Diseases Trigeminal Autonomic Cephalalgias

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Copenhagen, Glostrup, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic cluster patients

Exclusion criteria

-

Treatment and study plan

Neurostimulation

Device

Sham stimulation

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Plasma concentrations of PACAP38 and VIP

    Time frame: 0-60 min

    Difference in plasma concentrations of PACAP38 and VIP between LF and sham stimulation.

  3. 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.

  4. 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.

  5. Headache intensity

    Time frame: 0-60 min

    Difference in headache intensity measured by numerical rating scale (NRS 0-10) between LF and sham stimulation.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

Sphenopalataine Ganglion (SPG) Stimulation in Cluster Headache Patients

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 29, 2015
Registry last updated
Aug 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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