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

NCT ID: NCT05213065

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-05
• Study Completion Date: 2024-12-31

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

Conditions

Chronic Daily Headache; Post-Traumatic Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment Arm

The participants randomized into this arm will receive the SPG block with 0.5% bupivacaine.

Group Type: EXPERIMENTAL

Sphenopalatine ganglion block with 0.5% bupivacaine

Intervention Type: OTHER

Repetitive SPG blockade using 0.5% bupivacaine delivered with the Tx360® device.

Placebo Arm

The participants randomized into this arm will receive the SPG block with saline.

Group Type: PLACEBO_COMPARATOR

Sphenopalatine ganglion block with saline

Intervention Type: OTHER

Repetitive SPG blockade using saline delivered with the Tx360® device.

Interventions

Sphenopalatine ganglion block with 0.5% bupivacaine

Repetitive SPG blockade using 0.5% bupivacaine delivered with the Tx360® device.

Intervention Type: OTHER

Sphenopalatine ganglion block with saline

Repetitive SPG blockade using saline delivered with the Tx360® device.

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Louise and Alan Edwards Foundation

UNKNOWN

Sponsor Role: collaborator

Pablo Ingelmo

OTHER

Sponsor Role: lead

Responsible Party

Pablo Ingelmo

Head of Complex Pain Center ,Assistant Professor Pediatric-Anesthesiologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pablo Ingelmo, MD

Role: PRINCIPAL_INVESTIGATOR

Research Institute at the Montreal Childrens Hospital

Locations

McGill University Health Centre (MUHC) - Montreal Children's Hospital

Montreal, Quebec, Canada

Countries

Canada

Central Contacts

Marie Vigouroux

Role: CONTACT

marie.Vigouroux@mail.mcgill.ca

5144124448

Nada A Mohamed, MD

Role: CONTACT

nada.mohamed@mail.mcgill.ca

5144124448

References

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.

Reference Type: BACKGROUND

PMID: 34356585 (View on PubMed)

Other Identifiers

2021-7715

Identifier Type: -

Identifier Source: org_study_id