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Sphenopalatine Ganglion Block for Chronic Daily Headache (SPG Trial)
N/A
Waitlist Available
Led By Pablo Ingelmo, MD
Research Sponsored by Pablo Ingelmo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Head injury associated with specific symptoms and/or signs
No diagnosed or strongly suspected paroxysmal hemicrania or hemicrania continua
Timeline
Screening 3 weeks
Treatment Varies
Follow Up asked in last visit and 1 month after last intervention again at 3 months after last intervention
Awards & highlights
SPG Trial Summary
This trial is testing whether a device that blocks the sphenopalatine ganglion can reduce the intensity and severity of post-traumatic headaches in adolescents.
Who is the study for?
This trial is for children and adolescents aged 10 to 17.5 with chronic daily headaches due to mild traumatic brain injury, occurring within 7 days of the injury and persisting for over 3 months. Participants must not have certain nasal deformities, severe respiratory issues, a history of serious head injuries visible on brain imaging, or allergies to local anesthetics like bupivacaine.Check my eligibility
What is being tested?
The study tests if a transnasal sphenopalatine ganglion block can reduce headache intensity in young patients. It compares the use of saline against bupivacaine using the TX360 device and measures quality of life, headache severity, physical function, sleep quality, role function (PEDMIDAS), and adverse events.See study design
What are the potential side effects?
Potential side effects may include discomfort or pain at the application site in the nose, minor bleeding or nasal congestion post-treatment. Allergic reactions could occur but only in those with known allergies to bupivacaine which is an exclusion criterion.
SPG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a head injury with specific symptoms.
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I have not been diagnosed with or suspected to have paroxysmal hemicrania or hemicrania continua.
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I do not have any nasal or facial structure issues that would prevent the use of the TX360 device.
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My headache isn't caused by another known condition.
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My headache has lasted for more than 3 months.
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I do not have a bleeding disorder or frequent nosebleeds.
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I do not have severe breathing problems.
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I do not have angiofibroma, sinus tumors, or granuloma.
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I experience daily headaches due to a mild brain injury.
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I have never had brain bleeding or clots shown on scans due to a head injury.
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I am between 10 and 17.5 years old.
SPG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ asked in last visit and 1 month after last intervention again at 3 months after last intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~asked in last visit and 1 month after last intervention again at 3 months after last intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Days of Headache per Month
Secondary outcome measures
Functional Disability Inventory(FDI)
Measure Yourself Medical Outcome Profile ( MYMOP2)
Number of Analgesic Medications used
+4 moreOther outcome measures
Number and Type of Adverse events
SPG Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
The participants randomized into this arm will receive the SPG block with 0.5% bupivacaine.
Group II: Placebo ArmPlacebo Group1 Intervention
The participants randomized into this arm will receive the SPG block with saline.
Find a Location
Who is running the clinical trial?
Pablo IngelmoLead Sponsor
Louise and Alan Edwards FoundationUNKNOWN
2 Previous Clinical Trials
300 Total Patients Enrolled
Pablo Ingelmo, MDPrincipal InvestigatorResearch Institute at the Montreal Childrens Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bleeding disorder or have had frequent nosebleeds (more than 3 times a week) for the last 3 months.I've had a serious infection with symptoms lasting over 10 days and a fever above 38°C for more than a day.I have a broken nose or facial bone that prevents the use of certain medical devices.I have been diagnosed with angiofibroma, sinus tumors, or granuloma.I have had a head injury with specific symptoms.I have not been diagnosed with or suspected to have paroxysmal hemicrania or hemicrania continua.I experience severe difficulty breathing, with rapid breaths or visible strain.I have been diagnosed with or suspected to have a specific type of headache.I do not have any nasal or facial structure issues that would prevent the use of the TX360 device.My headache isn't caused by another known condition.My headache has lasted for more than 3 months.I do not have a bleeding disorder or frequent nosebleeds.I do not have severe breathing problems.I do not have angiofibroma, sinus tumors, or granuloma.I may have headaches from using too much medication, but they fit the study's criteria.I experience daily headaches due to a mild brain injury.I haven't had a serious infection lasting over 10 days or a fever above 38°C for more than a day.You have had an allergic reaction to bupivacaine, a type of local anesthetic, in the past.I have had a condition where my lymphocytes multiply unusually.I haven't had any cancer except for skin cancer in the last 5 years.I have a history of cancer.I have never had brain bleeding or clots shown on scans due to a head injury.I have had brain bleeding or clots due to a head injury.You have never had an allergic reaction to bupivacaine, a type of local anesthetic.I have a nasal or facial structure issue, like a cleft lip, or recent nasal surgery.I started having headaches within a week after a head injury or after stopping medication that affects my ability to feel or report headaches.I am between 10 and 17.5 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
- Group 2: Placebo Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available to individuals interested in participating in the trial?
"Unfortunately, the clinical trial's details on clinicialtrials.gov confirm that recruitment for this study has concluded. It was first posted in February 5th 2022 and updated lastly on January 14st 2022. Nevertheless, there are 136 other trials searching for patients at present."
Answered by AI
Does my health profile meet the requirements to participate in this clinical trial?
"This medical trial is recruiting up to 120 participants who are afflicted by cervicogenic headaches and range between 10-17 years of age."
Answered by AI
Is the cohort of this scientific investigation inclusive of elderly individuals?
"This medical research experiment necessitates that participants are between 10 and 17 years old. There are 19 clinical trials for minors while 91 exist targeting individuals 65 or older in age."
Answered by AI
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