SPG Neurostimulation in Cluster Patients

Danish Headache Center

Status: Completed

Conditions: Chronic Cluster Headache

Treatments: Device: Neurostimulation; Device: Sham stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02510729

H-15005609

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic cluster patients

Exclusion criteria

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

21 participants in 2 patient groups, including a placebo group

SPG neurostimulation

Active Comparator group

Description:

Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz

Treatment:

Device: Neurostimulation

Sham Stimulation

Placebo Comparator group

Description:

Sham stimulation with amplitude=0

Treatment:

Device: Sham stimulation