Clinical trial NCT05213065: Assessment of the Efficacy of the Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Daily Headache in Children and Adolescents.
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Daily Headache
Post-Traumatic Headache
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Louise and Alan Edwards Foundation
First posted: 2022-01-28
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

Subjects will be included if they meet all the following criteria:

1. Aged between 10 and 17.5 years old at the start of treatment
2. Daily Headache, within these categories:

   1. Persistent PTH attributed to Mild traumatic Brain injury to the head

Diagnostic criteria for persistent headache attributed to mild traumatic injury to the head:

Persistent headache attributed to traumatic injury to the head:

A. Any headache fulfilling criteria C and D B. Traumatic injury to the head1 has occurred

C. Headache is reported to have developed within 7 days after one of the following:

* Injury to the head
* Regaining of consciousness following injury to the head
* Discontinuation of medication(s) impairing ability to sense or report headache following injury to the head D. Headache persists for \>3 months after its onset E. Not better accounted for by another ICHD-3 diagnosis Persistent headache attributed to mild traumatic injury to the head A. Headache fulfilling criteria for 5.2 Persistent headache attributed to traumatic injury to the head

B. Head injury fulfilling both of the following:

1. Associated with none of the following:

   * Loss of consciousness for \>30 minutes
   * Glasgow Coma Scale (GCS) score \<13
   * Post-traumatic amnesia lasting \>24 hours1
   * Altered level of awareness for \>24 hours
   * Imaging evidence of a traumatic head injury such as skull fracture, intracranial hemorrhage and/or brain contusion
2. Associated with one or more of the following symptoms and/or signs:

   * Transient confusion, disorientation or impaired consciousness
   * Loss of memory for events immediately before or after the head injury
   * Two or more of the following symptoms suggestive of mild traumatic brain injury:
   * Nausea
   * Vomiting
   * Visual disturbances
   * Dizziness and/or vertigo
   * Gait and/or postural imbalance
   * Impaired memory and/or concentration

Exclusion Criteria:

1. Previous history of brain imaging showing evidence of intracerebral hemorrhage, subdural or epidural hematomas, or subarachnoid hemorrhage as a consequence of traumatic head injury
2. Previous history of local anesthetic allergic reaction to bupivacaine
3. Nasal septal deformity or malformed facial or nasal passages such as cleft lip and palate, choanal atresia, atrophic rhinitis, rhinitis medicamentosa, septal perforation, deviation of the nasal septum, nasal/midface trauma or if he has recently had nasal/sinus surgery
4. Nasal or facial fracture impeding the use of TX360 device
5. Serious infection with congestion more than 10 days, and rectal temperature higher than 38°C for more than 1 day9.
6. Current diagnose of bleeding disorder or recurrent untreated (\> 3/week) nosebleeds for the past 3 months
7. Severe respiratory distress, as noted by tachypnea or subcostal/intercostal retractions in when breathing
8. Angiofibroma, sinus tumors, or granuloma
9. Diagnosed or strongly suspected paroxysmal hemicrania or hemicrania continua
10. Pregnancy before the completion of the last dose
11. The possibility of a medication overuse headache is NOT an exclusion criterion, as long as the headache also corresponds to the inclusion criteria.

Primary outcomes:
measure: Number of Days of Headache per Month
timeFrame: up to 3 months after last intervention
Secondary outcomes:
measure: Pain Assessment during the headache
timeFrame: we will ask after every intervention and up to 3 months after last intervention
measure: Patient Global Impression of Change scale ( PGIC)
timeFrame: asked in last visit and 1 month after last intervention again at 3 months after last intervention
measure: Measure Yourself Medical Outcome Profile ( MYMOP2)
timeFrame: Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention
measure: Functional Disability Inventory(FDI)
timeFrame: Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention
measure: Pediatric Migraine Disability Assessment (PedMIDAS)
timeFrame: Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention
measure: Number of Analgesic Medications used
timeFrame: up to 3 months after last intervention
Other outcomes:
measure: Number and Type of Adverse events
timeFrame: up to 3 months after last intervention
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC) - Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: Research Institute at the Montreal Childrens Hospital
name: Pablo Ingelmo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kouri M, Somaini M, Cardenas VHG, Niburski K, Vigouroux M, Ingelmo P. Transnasal Sphenopalatine Ganglion Block for the Preventive Treatment of Chronic Daily Headache in Adolescents. Children (Basel). 2021 Jul 18;8(7):606. doi: 10.3390/children8070606.