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Sphenopalatine Ganglion Stimulation Possible Tool for Cluster Headaches

February 13, 2018
SPG stimulation may provide effective pain relief for some patients who suffer from a severe one-sided neurovascular migraine type cluster headache.

With Mads Barloese, MD, PhD, and Lawrence Robbins, MD

Physicians who treat patients with cluster headaches (CH) may now have a new pain management tool—microstimulation of the sphenopalatine ganglion (SPG)—to help provide symptom relief.1

SPG stimulation is an effective treatment for CH patients to reduce their need for medications and improve their quality of life,1 said study author Mads Barloese, MD, PhD, and colleagues at the Danish Headache Centre in Glostrup, Denmark, in findings published in The Journal of Headache and Pain.

SPG stimulation tool offers pain relief and improved quality of life for patients with cluster headaches.Photo courtesy Autonomic Technologies, Inc., Redwood City, CA

Cluster headaches are among the most painful experiences known,,2 and are characterized by a severe one-sided neurovascular headache with a variety of associated parasympathetic and local symptoms near the side of the head, including nasal congestion and periorbital pain and edema.2,3 Attacks may be frequent or sporadic and range from 15 minutes to three hours per episode.2 They may even occur multiple times a day,2 but not all patients have gained symptom relief from cluster headaches through pharmacological means.1

Microstimulation of the SPG Promising for Cluster Headaches

“SPG stimulation appears very useful to manage cluster headaches since the ATI implantable device has had good success in Europe, and just finished the trial here in the US,”4 said neurologist Lawrence Robbins, MD, founder of the Robbins Headache Clinic in Chicago, Illinois, referring to findings published by Barloese and colleagues, and “they had reasonable efficacy, with relatively few side effects.”

The SPG has long been a location of interest in the development of treatments for CH due to its association with the trigeminal-autonomic reflex.2,3 Interventions involving this structure have ranged from lidocaine injections to ganglionectomy and others.2

The mode of intervention presented by Dr. Barloese and colleagues involves neurostimulation using a handheld device that the patient uses to interact with a microstimulator, inserted through the mouth and implanted near the SPG.1 Dr. Robbins explained that “an externally held tool then connects with the implanted device to create an interaction at the originating site of the pain.”

A Closer Look at Sphenopalatine Ganglion Stimulation

A total of 97 patients with cluster headaches participated in this prospective, open-label research study.1 The study duration was 12 months following surgical insertion of the microstimulator. Effects of the therapy on multiple factors related to the occurrence of CH, such as a reliance on other treatments and overall quality of life, were monitored clinically and by patients during CH attacks via an electronic diary linked to the device.1

To participate in the study, patients were diagnosed as experiencing cluster headaches for at least 16 weeks. Exclusion criteria included recent changes in preventive medicine as well as facial structural issues that would preclude appropriate placement of the microstimulator.1

Implant portion of the SPG microstimulator device for cluster headaches.Photo courtesy Autonomic Technologies, Inc., Redwood City, CA

In this study, patients were instructed to use the microstimulation system for at least 15 minutes upon CH onset, and they were permitted to use the system prophylactically as desired. The neurostimulatory system used in the study was the PulsanteTM SPG Microstimulator System (Autonomic Technologies, Inc. (ATI), Redwood City, CA).1

Throughout the study duration, 85 patients maintained the microstimulator implants, although eight required repositioning with seven having adjustments on the day of the original placement following examination by CT scan.1 Favorable treatment responses were reported by 68% of patients. A reduction in CH frequency of at least 50% was experienced in 55% of patients with chronic CH (P < .0001). A total of 74% of participants with chronic cluster headaches reported reducing or discontinuing use of preventive medicines, and 47% of chronic CH sufferers reported at least a 75% therapeutic effect.1

Two-thirds of patients who typically used other acute treatments for CH showed 52% less reliance on such treatments; the incidence of acute treatments in the 82 patients who used them dropped from 22.0 + 21.3 per week to 10.6 + 17.6 per week (P < .0001). The authors reported that at least 50% of attacks were treated effectively using SPG stimulation in 32% of patients, and headache disability was lessened in 59% of all patients.1

Building Surgical Proficiency Remains Necessary for Clinical Use

“Over half of the cluster headache patients had a reasonable response,” said Dr. Robbins, “For some, the use of this [device] also helped cut down on the number of clusters experienced; however, it is intended primarily an abortive, acute treatment.”

The procedure presents with the usual surgical cautions. “There are potential side effects of the surgery such as numbness and swelling, among others. Usually, side effects fade over a month or two. However, it is an invasive procedure with potential problems, including placement discomfort. Despite this, the stimulator does not have the side effects of certain drugs,” Dr. Robbins said.

“The procedure needs an experienced surgeon, which in the US will take time to occur,” Dr. Robbins told Practical Pain Management, also noting that “ATI has successfully run double-blind RCTs (randomized controlled trials) of the SPG implant in Europe, and it has been there for over five years which suggests they have a good track record of efficacy and safety. U.S. results are pending.4

Dr. Robbins also noted that a feature of the microstimulator in this study – its wireless nature – avoids hazards faced with wired implants, such as the wire migrating within the oral tissue.

 Authors Barloese, Jürgens, Jensen, and May are or have previously been paid consultants for Autonomic Technologies, Inc., Redwood City, CA, which funded the study.

Last updated on: February 14, 2018
Continue Reading:
Preventive Therapies for Cluster Headaches

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