NCT05213065

Assessment of the Efficacy of the Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Daily Headache in Children and Adolescents.

Efficacy of Transnasal Sphenopalatine Ganglion Block Using TX360® Device for Children and Adolescents With Chronic Daily Headaches: A Single Center, Prospective, Randomized, Double Blind, Placebo-controlled Study Assessing the Efficacy of the Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Daily Headache in Children and Adolescents

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Pablo Ingelmo · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective The primary objective of the study is to assess whether transnasal sphenopalatine ganglion block using the device TX360 reduces intensity and severity of the Post-Traumatic Headache in adolescents. Secondary Objectives The study will also evaluate: * Quality of life (QoL) * Intensity of the headache * Physical function * Sleep quality * Role function (measured by PEDMIDAS) * Adverse events

Detailed description

The sphenopalatine ganglion (SPG) is a large network of neurons that is easily accessible through the middle turbinate. The SPG is composed of branches from V1 and V2 of the trigeminal nerve and interconnects with sympathetic and parasympathetic autonomic fibers.6 The SPG has been successfully targeted transnasally to treat headache disorders and associated autonomic symptoms in adults.7 SPG blockade has been used in adults for treating several headache and facial pain conditions such as migraine, cluster headache, and trigeminal neuralgia.8 To our knowledge, there has not been any similar study done in children and adolescents. The Tx360® device (Tian Medical Inc., Lombard, IL, USA) allows for noninvasive blockade of the SPG using a small catheter below the middle turbinate of the nose that is administered just beyond the pterygopalatine fossa. Regarding the efficacity of Tx360®, recent studies show that repetitive SPG blockade using 0.5% bupivacaine delivered with the Tx360® device was well-tolerated and effective at decreasing baseline headache intensity in adults.6

Conditions

• Chronic Daily Headache
• Post-Traumatic Headache

Interventions

Type	Name	Description
OTHER	Sphenopalatine ganglion block with 0.5% bupivacaine	Repetitive SPG blockade using 0.5% bupivacaine delivered with the Tx360® device.
OTHER	Sphenopalatine ganglion block with saline	Repetitive SPG blockade using saline delivered with the Tx360® device.

Timeline

• Start date: 2022-02-05
• Primary completion: 2024-02-01
• Completion: 2024-12-01
• First posted: 2022-01-28
• Last updated: 2022-01-28

Locations

1 site across 1 country: Canada