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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPG neurostimulation | Active Comparator | Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz |
|
| Sham Stimulation | Placebo Comparator | Sham stimulation with amplitude=0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurostimulation | Device |
| ||
| Sham stimulation |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Messoud Ashina, Prof. | Danish Headache Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center | Copenhagen | Glostrup | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29082824 | Derived | Guo S, Petersen AS, Schytz HW, Barlose M, Caparso A, Fahrenkrug J, Jensen RH, Ashina M. Cranial parasympathetic activation induces autonomic symptoms but no cluster headache attacks. Cephalalgia. 2018 Jul;38(8):1418-1428. doi: 10.1177/0333102417738250. Epub 2017 Oct 30. |
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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|
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 |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |