An interventional study of Gasserian Ganglion Radiofrequency Thermocoagulation in Trigeminal Neuralgia and Gasserian Ganglion; Lesion, sponsored by Başakşehir Çam & Sakura City Hospital. Recruiting at 1 site in Turkey. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by Başakşehir Çam & Sakura City Hospital · Not applicable, Interventional, and Treatment
Trigeminal neuralgia is common painful disorder in pain medicine clinics. Gasserian ganglion radiofrequency thermocoagulation is one of the treatment option in patients with trigeminal neuralgia in refractory cases. The most commonly involved branch in trigeminal neuralgia is the mandibular branch. Masseter muscle is innervated by mandibulary nerve branch of the trigeminal nerve.
The radiofrequency thermocoagulation therapy is used to ablate the affected trigeminal nerve branch and some of patients complain of subjective masseter weakness after this procedure.
In theoretical basis, muscles innervated by target nerve are affected from ablation procedure. In this study the primary aim is to evaluate the change of the masseter muscle thickness in patients treated by gasserian ganglion radiofrequency thermocoagulation. The results may also show possible functional effect of the procedure related with masseter muscle.
140 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 93 interventional studies indexed under Trigeminal Neuralgia.
Browse Trigeminal Neuralgia studies →Başakşehir Çam & Sakura City Hospital is the lead sponsor of 109 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In patients who have undergone radiofrequency thermocoagulation (RFT) of the gasserian ganglion for the treatment of trigeminal neuralgia, the thickness of the masseter muscle will be measured bilaterally, free and contracted, by ultrasound on the day of the procedure (just before the procedure) and at 1 and 3 months after the procedure.
Procedure: Gasserian Ganglion Radiofrequency Thermocoagulation
Gasserian ganglion radiofrequency thermocoagulation is performed in the operating room under fluoroscopy. In sterile condition, the foramen ovale is shown by the pain management specialist under fluoroscopy guidance. After this condition, the entry of the needle is marked and anaesthetised with local anaesthetic. After the entry of the gasserian ganglion with the radiofrequency needle, 10 cm long, the location is checked with sensory and motor stimulation. If the placement is correct, 70 degrees 70 seconds of radiofrequency thermocoagulation is applied.
Masseter muscle thickness
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Time frame: Pre-procedural time
Masseter muscle thickness
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Time frame: Post-procedural first month
Masseter muscle thickness
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Time frame: Post-procedural third month
Started Mar 2024 (actual). Primary completion is estimated for Jul 2025, 16 months after the start.
Of 33 non-industry interventional studies with no phase under Trigeminal Neuralgia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 16 months is below that.
Counting every sponsor, half of 33 studies reached it within 27 months; a quarter within 11 and three quarters within 40.
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