SPG Neurostimulation in Cluster Patients

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

Detailed Description
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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.

Official Title
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Sphenopalataine Ganglion (SPG) Stimulation in Cluster Headache Patients

Conditions
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Chronic Cluster Headache

Intervention / Treatment
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* Device: Neurostimulation
* Device: Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic cluster patients Exclusion Criteria: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Plasma concentrations of PACAP38 and VIP | Difference in plasma concentrations of PACAP38 and VIP between LF and sham stimulation. | 0-60 min | 
| 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 | 
| Mean arterial blood pressure and heart rate | Difference in mean arterial blood pressure and heart rate between LF and sham stimulation. | 0-60 min | 
| Headache intensity | Difference in headache intensity measured by numerical rating scale (NRS 0-10) between LF and sham stimulation. | 0-60 min |