Jamtøy, Kent Are

Background The sphenopalatine ganglion (SPG) has previously been targeted in trigeminal neuralgia (TN), but its role in this condition has not been established. Objective To investigate the safety of injecting onabotulinumtoxinA (BTA) toward the SPG using the MultiGuide ® in 10 patients with refractory classical TN, and collect preliminary efficacy data. Methods Twenty‐five international units (IU) of BTA were injected toward the SPG in a prospective, open‐label study in 10 patients with refractory classical TN. All patients were recruited and treated on an out‐patient basis at St. Olav's University Hospital in Trondheim (Norway). Primary outcome: adverse events (AEs). Primary efficacy outcome: number of TN attacks at weeks 5‐8 after injection compared to baseline. A treatment responder was predefined as at least 50% reduction in the median number of attacks per day between baseline and weeks 5‐8. Other efficacy outcomes were intensity of attacks (numeric rating scale, 0 to 10) and functional level (1 to 4; 1 best and 4 worst) at weeks 5‐8 after injection compared to baseline. Percentage of the day with concomitant persistent pain was registered at baseline and at weeks 1‐4, 6, 8, and 12 after injection. Patient global impression of change (PGIC) was ascertained at month 3. Results For the primary endpoint, we analyzed data for all 10 patients. For efficacy outcomes we analyzed data for 9 patients (1 patient violated protocol). We registered 13 AEs, none of which were serious. The median number of TN attacks during the 4‐week baseline and weeks 5‐8 after injection was 5.5 (range: 1.0‐51.5) and 5 (range: 0‐225.0), respectively ( P = .401). Four patients were treatment responders. The median intensity of attacks at baseline and weeks 5‐8 after injection was 6 (range: 3.0‐8.5) and 3 (range: 0.0‐9.0) respectively ( P = .024). The median functional level at baseline was 2 (range: 1.0‐3.3) and at month 2, 1 (range 1.0‐4.0; P = .750). Median percentage of the day with concomitant persistent pain was 75% (minimum 37.5%, maximum 100%) at baseline and 18.75% (minimum 0%, maximum 100%) at week 8 ( P = .023). Conclusions Injection of BTA toward the SPG using the MultiGuide ® in patients with TN appears to be safe and well tolerated. This study was negative for the main efficacy endpoint (reduction in the number of attacks from baseline to weeks 5‐8). Further studies examining the role of the SPG in TN are necessary.

Background: The sphenopalatine ganglion (SPG) is a target for several headache syndromes. Most of the groups targeting the SPG do not localize it directly, and this might account for some therapeutic failures. As the SPG cannot be seen on computerized tomography (CT) scans, magnetic resonance image (MRI) must be used to visualize the ganglion. It would be advantageous to be able to predict the location of the SPG on CT scans for those using fluoroscopy or CT-guided injections and for those in whom MRI is not accessible or contraindicated. Methods: We localized the SPG in 21 Caucasian patients (21 right and 17 left ganglia; total 38) in 3 tesla MR images subsequently fused with CT scans. We measured the distance from the SPG to two bony landmarks identified on CT scans. We then applied the average distances to find an estimated position of the SPG. The first landmark was the center of the anterior opening of the vidian canal (VC). The second landmark was a point on the sphenoidal bone, defined in an axial plane at the level of the center of the VC (S-point). The predicted position of the SPG measured from the VC and the sphenoidal bone were referred to as, respectively, vcSPG and sSPG. Finally, the distances between the SPG, as seen on MRI, and predicted vcSPG/sSPG were calculated. Results: The average distance between SPG as seen on the MRI images and the estimated position based on CT images were 1.82 mm (SD 0.83, range 0.22–3.57 mm) for vcSPG and 2.09 mm (SD 0.99, range 0.71–4.79 mm) for sSPG. Conclusions: The localization of the SPG can be predicted on CT images using bony landmarks. Localization of the SPG may be important in achieving successful therapeutic outcomes for treatments that are directed toward the SPG.