SPG Neurostimulation in Cluster Patients

NCT ID: NCT02510729

Last Updated: 2017-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-10-31

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.

Conditions

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Chronic Cluster Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SPG neurostimulation

Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz

Group Type ACTIVE_COMPARATOR

Neurostimulation

Intervention Type DEVICE

Sham Stimulation

Sham stimulation with amplitude=0

Group Type PLACEBO_COMPARATOR

Sham stimulation

Intervention Type DEVICE

Interventions

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Neurostimulation

Intervention Type DEVICE

Sham stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Chronic cluster patients

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Song Guo

MD, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Messoud Ashina, Prof.

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center

Locations

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Danish Headache Center

Copenhagen, Glostrup, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 29082824 (View on PubMed)

Other Identifiers

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H-15005609

Identifier Type: -

Identifier Source: org_study_id

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