Chronic Cluster Headache
Conditions
Brief summary
We hypothesized that LF stimulation of the SPG would increase parasympathetic outflow, activate sensory afferents and provoke a cluster-like attack.
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.
Interventions
DEVICENeurostimulation
DEVICESham stimulation
Sponsors
Danish Headache Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Chronic cluster patients
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cluster-like attacks and cephalic autonomic symptoms | 0-60 min | Difference in incidence of cluster-like attacks and cephalic autonomic symptoms between LF and sham stimulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical detection and pain thresholds | 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. |
| Plasma concentrations of PACAP38 and VIP | 0-60 min | Difference in plasma concentrations of PACAP38 and VIP between LF and sham stimulation. |
| Cardiac autonomic regulation (HRV) | 0-60 min | Changes in cardiac autonomic regulation (HRV) between LF and sham stimulation and during cluster attacks measured by continious ECG. |
| Mean arterial blood pressure and heart rate | 0-60 min | Difference in mean arterial blood pressure and heart rate between LF and sham stimulation. |
| Headache intensity | 0-60 min | Difference in headache intensity measured by numerical rating scale (NRS 0-10) between LF and sham stimulation. |
Countries
Denmark
Outcome results
None listed