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Sphenopalatine Ganglion Stimulation

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Two related studies


Cluster headache attack remission with sphenopalatine ganglion stimulation: experiences in chronic cluster headache patients through 24 months; Barloese M, Jürgens T, May A, Lainez J, Schoenen J, Gaul C, Goodman A, Caparso A, Jensen R; The Journal of Headache and Pain 17 (1), 67 (Dec 2016)

BACKGROUND Cluster headache (CH) is a debilitating headache disorder with severe consequences for patient quality of life. On-demand neuromodulation targeting the sphenopalatine ganglion (SPG) is effective in treating the acute pain and a subgroup of patients experience a decreased frequency of CH attacks.

METHODS We monitored self-reported attack frequency, headache disability, and medication intake in 33 patients with medically refractory, chronic CH (CCH) in an open label follow-up study of the original Pathway CH-1 study. Patients were followed for at least 24 months (average 750 ± 34 days, range 699-847) after insertion of an SPG microstimulator. Remission periods (attack-free periods exceeding one month, per the ICHD 3 (beta) definition) occurring during the 24-month study period were characterized. Attack frequency, acute effectiveness, medication usage, and questionnaire data were collected at regular clinic visits. The time point'after remission'was defined as the first visit after the end of the remission period.

RESULTS Thirty percent (10/33) of enrolled patients experienced at least one period of complete attack remission. All remission periods followed the start of SPG stimulation, with the first period beginning 134 ± 86 (range 21-272) days after initiation of stimulation. On average, each patient's longest remission period lasted 149 ± 97 (range 62-322) days. The ability to treat acute attacks before and after remission was similar (37 % ± 25 % before, 49 % ± 32 % after; p = 0.2188). Post-remission headache disability (HIT-6) was significantly improved versus baseline (67.7 ± 6.0 before, 55.2 ± 11.4 after; p = 0.0118). Six of the 10 remission patients experienced clinical improvements in their preventive medication use. At 24 months post insertion headache disability improvements remained and patient satisfaction measures were positive in 100 % (10/10).

CONCLUSIONS In this population of 33 refractory CCH patients, in addition to providing the ability to treat acute attacks, neuromodulation of the SPG induced periods of remission from cluster attacks in a subset of these. Some patients experiencing remission were also able to reduce or stop their preventive medication and remissions were accompanied by an improvement in headache disability.



Source: DGNews  |  Posted 11 weeks ago
Sphenopalatine Ganglion Microstimulator System Safe, Effective for Chronic Cluster Headache: Presented at EAN

By Chris Berrie

COPENHAGEN, Denmark -- June 2, 2016 -- A sphenopalatine ganglion (SPG) microstimulator system (Pulsante) is safe and effective in the treatment of medically refractory patients with chronic cluster headache (CCH), according to 24-month efficacy data presented here at the 2nd International Congress of the European Academy of Neurology (EAN).

According to Rigmor Højland Jensen, MD, Danish Headache Centre, Rigshospitalet-Glostrup, Glostrup, Denmark, patients with CCH are “underdiagnosed and undertreated, and they have a high number of consultations and inappropriate interventions.â€

The Pulsante system is a minimally-invasive, rechargeable, multi-channel, peripheral nerve stimulation system. The system includes an insert (the microstimulator) that is smaller than an almond with an integral lead designed to fit ranging facial anatomy; and a remote with simple controls that provides on-demand patient-controlled SPG therapy. Therapy settings are individualised and can be adjusted quickly by physicians using a programmer laptop.

A total of 43 patients with CCH were enrolled in the Pathway CH-1 study. Of the patients, 33 continued into a long-term follow-up study and completed at least 24 months of follow-up.

All patients were refractory or intolerant to medical treatment, with a mean attack frequency of 16.8 headaches per week, and HIT-6 headache disability of 66.7.

Each treated attack was evaluated for effective therapy (pain relief from moderate or greater pain, or pain freedom from mild pain). Acute responders achieved effective therapy in ≥50% of evaluable treatments. Frequency responders experienced a ≥50% reduction in attack frequency compared with baseline.

A total 5,956 attacks were treated among all 33 patients (19% mild initial pain, 45% moderate, 23% severe, 13% very severe).

Of these attacks, 65% achieved effective therapy (64% of mild attacks, 78% of moderate, 62% of severe, 23% of very severe). Of the 33 patients, 61% experienced clinically significant improvements, with 5 patients classified as both acute and frequency responders, 10 classified as acute, and 5 classified as frequency responders.

Acute responders successfully treated, on average, 75% of their cluster attacks. Frequency responders experienced, on average, an 82% reduction in attack frequency.

Further benefits were seen in the proportions of patients showing clinical improvements in preventive medicine use (64%), improved headache disability (HIT-6, at least 2-3-point decrease; 55%), and improved quality of life (73%).

The most common surgical side effects were sensory disturbance (67%) and pain and/or swelling (35%), with 70% of these resolved within 90 days.

“We didn’t see any additional adverse side effects over this time,†said Dr. Jensen.

Funding for this study was provided by Autonomic Technologies, Inc.

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