Chronic Daily HeadacheSPGNCT05213065
Assessment of the Efficacy of the Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Daily Headache in Children and Adolescents.
A study testing Sphenopalatine ganglion block with 0.5% bupivacaine and Sphenopalatine ganglion block with saline in people with Chronic Daily Headache and Post-Traumatic Headache, run by Pablo Ingelmo at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Chronic Daily Headache, Post-Traumatic Headache
- What is being tested?
- Sphenopalatine ganglion block with 0.5% bupivacaine and Sphenopalatine ganglion block with saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 5 Feb 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
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- Any headache fulfilling criteria C and D B. Traumatic injury to the head1 has occurred
- 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
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University Health Centre (MUHC) - Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
About this study
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
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
Read the 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
- Being tested
- Sphenopalatine ganglion block with 0.5% bupivacaine, Sphenopalatine ganglion block with saline
- Medical subject headings
- Headache Disorders, Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine ganglion block with 0.5% bupivacaineOther
Repetitive SPG blockade using 0.5% bupivacaine delivered with the Tx360® device.
Sphenopalatine ganglion block with salineOther
Repetitive SPG blockade using saline delivered with the Tx360® device.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | The participants randomized into this arm will receive the SPG block with 0.5% bupivacaine. Receives: Other: Sphenopalatine ganglion block with 0.5% bupivacaine |
| Placebo Arm | Placebo comparator | The participants randomized into this arm will receive the SPG block with saline. Receives: Other: Sphenopalatine ganglion block with saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days of Headache per Month
Number of Days of Headache per Month
Measured: up to 3 months after last intervention
Secondary outcomes (7)
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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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 .
Measured: up to 3 months after last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start5 Feb 2022 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Daily HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pablo Ingelmo
- Sponsor type
- University, hospital or other
- Collaborators
- Louise and Alan Edwards Foundation
- Responsible party
- Sponsor-investigator, Pablo Ingelmo, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Pablo Ingelmo, MD, Principal investigator, Research Institute at the Montreal Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213065
- Sponsor's protocol ID
- 2021-7715
- Acronym
- SPG
- Status last verified
- Jan 2022
- First submitted
- 20 May 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34356585
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05213065
- Acronym / sponsor ID
- SPG / 2021-7715
- Conditions
- Chronic Daily Headache, Post-Traumatic Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pablo IngelmoUniversity, hospital or other
- Collaborators
- Louise and Alan Edwards Foundation
- Study start
- 5 Feb 2022 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Other: Sphenopalatine ganglion block with 0.5% bupivacaineThe participants randomized into this arm will receive the SPG block with 0.5% bupivacaine. |
| Placebo Arm | Placebo comparator | Other: Sphenopalatine ganglion block with salineThe participants randomized into this arm will receive the SPG block with saline. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (28 listed)
- Aged between 10 and 17.5 years old at the start of treatment
- Daily Headache, within these categories:
- Diagnostic criteria for persistent headache attributed to mild traumatic injury to the head:
- Any headache fulfilling criteria C and D B. Traumatic injury to the head1 has occurred
- Headache is reported to have developed within 7 days after one of the following:
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sphenopalatine ganglion block with 0.5% bupivacaineRepetitive SPG blockade using 0.5% bupivacaine delivered with the Tx360® device. | Other | Treatment Arm |
| Sphenopalatine ganglion block with salineRepetitive SPG blockade using saline delivered with the Tx360® device. | Other | Placebo Arm |
Primary outcome
Number of Days of Headache per Month
Time frame: up to 3 months after last intervention
Number of Days of Headache per Month
7 secondary outcomes
Pain Assessment during the headache
Time frame: we will ask after every intervention and up to 3 months after last intervention
Patient Global Impression of Change scale ( PGIC)
Time frame: asked in last visit and 1 month after last intervention again at 3 months after last intervention
Measure Yourself Medical Outcome Profile ( MYMOP2)
Time frame: Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention
Functional Disability Inventory(FDI)
Time frame: Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention
Pediatric Migraine Disability Assessment (PedMIDAS)
Time frame: Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention
Number of Analgesic Medications used
Time frame: up to 3 months after last intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Background: PubMed 34356585Kouri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Ingelmo, MD principal investigator
Research Institute at the Montreal Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sphenopalatine ganglion block with 0.5% bupivacaine and Sphenopalatine ganglion block with saline in people with Chronic Daily Headache and Post-Traumatic Headache, run by Pablo Ingelmo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Vigouroux (5144124448, marie.Vigouroux@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days of Headache per Month (time frame: up to 3 months after last intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05213065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.