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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Chronic Daily Headache, Post-Traumatic Headache

Intervention / Treatment
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* Other: Sphenopalatine ganglion block with 0.5% bupivacaine
* Other: Sphenopalatine ganglion block with saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be included if they meet all the following criteria: Aged between 10 and 17.5 years old at the start of treatment Daily Headache, within these categories: 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: 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 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: Previous history of brain imaging showing evidence of intracerebral hemorrhage, subdural or epidural hematomas, or subarachnoid hemorrhage as a consequence of traumatic head injury Previous history of local anesthetic allergic reaction to bupivacaine 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 Nasal or facial fracture impeding the use of TX360 device Serious infection with congestion more than 10 days, and rectal temperature higher than 38°C for more than 1 day9. Current diagnose of bleeding disorder or recurrent untreated (> 3/week) nosebleeds for the past 3 months Severe respiratory distress, as noted by tachypnea or subcostal/intercostal retractions in when breathing Angiofibroma, sinus tumors, or granuloma Diagnosed or strongly suspected paroxysmal hemicrania or hemicrania continua Pregnancy before the completion of the last dose The possibility of a medication overuse headache is NOT an exclusion criterion, as long as the headache also corresponds to the inclusion criteria.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>The participants randomized into this arm will receive the SPG block with 0.5% bupivacaine. | Other: Sphenopalatine ganglion block with 0.5% bupivacaine<br>* Repetitive SPG blockade using 0.5% bupivacaine delivered with the Tx360® device.<br>|
| Placebo Comparator: Placebo Arm<br>The participants randomized into this arm will receive the SPG block with saline. | Other: Sphenopalatine ganglion block with saline<br>* Repetitive SPG blockade using saline delivered with the Tx360® device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days of Headache per Month | Number of Days of Headache per Month | up to 3 months after last intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment during the headache | using a Questionnaire that includes the following : Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, that fits best to their pain intensity . Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible. | we will ask after every intervention and up to 3 months after last intervention | 
| Patient Global Impression of Change scale ( PGIC) | Patient Global Impression of Change scale ( PGIC) is a rating scale offered through a questionnaire that is most commonly used in clinically important changes after treatments and it has been used extensively in studies of musculoskeletal conditions. The patient is asked to describe changes in limitation, symptoms, emotions and overall quality of life related to the treatment received. Below is the scale that will be used: 'no change or condition got worse' = 0%; 'almost the same, hardly any change at all'=17%; 'a little better, but no noticeable change'=34%; 'somewhat better, but the change has not made any real difference'=50%; 'moderately better, and a slight but noticeable change' = 67%; 'better and definite improvement that has made a real and worthwhile difference | asked in last visit and 1 month after last intervention again at 3 months after last intervention | 
| Measure Yourself Medical Outcome Profile ( MYMOP2) | Measure Yourself Medical Outcome Profile (MYMOP2 ) is a 'patient-centred' outcome scale where patients are asked to nominate one or two symptoms (physical or mental) of a specific problem they need assistance with and consider the severity of these symptoms over the last week. Aims to measure the outcomes that the patient considers the most important. The patient chooses one or two symptoms for which they are seeking help and that they consider most important. They also choose an activity of daily living that is limited or prevented by these symptoms. These choices are written down in the patient's own words and the patient scores them for severity over the past week on a seven-point scale. Lastly, wellbeing is scored on a similar scale. On follow-up questionnaires, the wording of the previously chosen symptoms is unchanged. Follow-up questionnaires will be admin | Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention | 
| Functional Disability Inventory(FDI) | Functional Disability Inventory (FDI) was developed to measure physical functioning in school-aged children and adolescents. This measure relates to the ability to perform a range of everyday physical activities and has been well-established with different populations. The total FDI score is a sum of all of the items. Clinical reference points were developed to identify 3 categories of disability in pediatric chronic pain: no/minimal disability (0 -12) moderate disability (13-29) severe disability (>30) | Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention | 
| Pediatric Migraine Disability Assessment (PedMIDAS) | Pediatric Migraine Disability Assessment (PedMIDAS) was developed to assess migraine disability in pediatric and adolescent patients It has been tested and validated for ages 4 to 18. The score is a simple composite of the total of six questions. If a range is provided, use the high end of the range or ask the family to provide a single number - both methods show equal validity. If the answer is blank or is a phrase (i.e., few or couple), they need to be asked to provide a number. The PedMIDAS grading scale is as follows: Little or none disability (0-10) Mild disability (11-30) Moderate disability (31-50) Severe disability (>50) | Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention | 
| Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index (PSQI) We evaluate sleep quality using PSQI. The scale counts 19 items assessing sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Point values of each item in of the seven subscales are summed and then combined as indicated to generate a subscale score. These totals are summed to create the global PSQI score. Scores range from 0-5 indicates good quality of sleep. | Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention | 
| Number of Analgesic Medications used | Patients will be encouraged to continue with their previous treatments and will not be asked to stop taking any medications in order to participate in this study. However, they will be allowed to reduce the doses or, eventually, to stop the use of analgesic medication under medical supervision. The number and class of analgesics taken will be collected at baseline, at the end of the treatment, and 1 and 3 months after the end of the treatment. The less the Analgesics medications used the Better . | up to 3 months after last intervention |