CINTHA Trial. A randomised clinical study to investigate the effectiveness of sphenopalatine ganglion stimulation in cluster headache

Authors: T. Forouzanfar, K. Karagozoglu, E. Couturie
Source: Oral & Maxillofacial Surgery, March 2017, Vol. 46, Supplement 1, 204


Background: Chronic cluster headache (CCH) is a debilitating disorder with a significant impairment for the patient leading to low quality of life. The sphenopalatine ganglion (SPG) proved to play an important role in CCH pathophysiology.

Objectives: A randomised clinical trial (RCT) was designed (CINTHA Trial) to evaluate the effectiveness of SPG stimulation by a neurostimulator implant in medically refractory, chronic CCH patients.

Methods: The RCT consist of 5 stages including the baseline stage, implantation/recovery stage, treatment titration stage, validation stage and follow-up stage. The titration stage is used to find out the SPG stimulation intensity with the most pain reduction for each patient. A stimulation with this intensity and a control non-stimulation are applied to the patients randomly during the validation stage. In total 35 patients have to be included in the study. Pain intensity, medication usage, quality of life and costs will be assessed. The study is granted by the Dutch Health care system (Innovatiefonds zorgverzekeraars) and ATI systems.

Findings: The study started in 2015 and is still ongoing. The study protocol, the preliminary results and complications will be discussed.

Conclusion: The SPG stimulation proved to be effective, however the implantation of the neurostimulation can be time consuming and the implantation can lead serous complications.

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