Greater Occipital Nerve Block for Spontaneous Intracranial Hypotension

NCT06374524 | Recruiting

• 1 other identifier: 24-5568
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Spontaneous Intracranial Hypotension (SIH) is a debilitating neurological disorder caused by a cerebrospinal fluid leak (CSF), with an estimated incidence of 5 per 100,000 persons per year, of which mostly women between the ages of 35 years and 55 years. The typical presentation is moderate-to-severe orthostatic headache and several other possible neurological symptoms, that significantly impact patients' quality of life. Treatment of SIH usually starts with conservative measures, consisting of strict supine bed rest, hydration, caffeine, and simple analgesics. The vast majority of patients will require invasive treatments for their CSF leak, such as epidural blood patches, fibrin glue patches, endovascular coiling, and/or surgical repair. These specialized treatments are only offered in tertiary care centers and require specialized personnel and resources, which implicates a certain waiting time for the patients before permanent treatment is offered. In the meantime, due to the lack of an effective and accessible alternative, patients continue to suffer. The greater occipital nerve block (GONB) has been reported as a simple, safe, and effective treatment to provide short-to-intermediate term relief of migraine, cervicogenic headache, cluster headache, occipital neuralgia, and more recently, post-dural puncture headaches (PDPH). As the pathophysiology of intracranial hypotension caused by SIH or PDPH is very similar, it is stipulated that the effect of GONB will be similar for SIH patients. However, to date, no studies exploring the efficacy of GONB for SIH have been performed. The investigators propose to do a prospective observational study to explore the outcome of GONB for SIH. GONB can serve as a bridge therapy to control the debilitating headache of SIH while patients are awaiting permanent SIH treatment. Moreover, GONB can be performed by physicians of different specialties including neurology, which makes it an accessible treatment for all patients. Lastly, by offering better symptom control, this intervention could potentially restore patients' ability to work and reduce healthcare costs.

Conditions

Spontaneous Intracranial Hypotension

Outcome Measures

Primary Outcomes (1)

• Change in headache intensity

  The difference in the change in intensity of headache, as measured on an 11-point Numerical Rating Scale (NRS), measured 30 minutes after the intervention, after being positioned in an upright position for 10 minutes, compared to baseline.

  30 minutes post intervention

Secondary Outcomes (10)

• pain intensity

  day 1,3,7,14

• Onset of headache

  at 30 minutes post-intervention and on the morning of day 1, 3, 7, and 14 post-intervention

• Sitting endurance

  at 30 minutes post-intervention and on the morning of days 1, 3, 7, and 14 post-intervention (in minutes

• SIH associated central nerve system symptoms, such hearing loss, tinnitus, tremor, balance difficulties

  at 30 minutes post-intervention and on days 1, 3, 7, and 14 post-intervention

• Level of generalized anxiety

  at day 14 post-intervention

Interventions

greater occipital nerve block PROCEDURE

Patients will receive an ultrasound-guided bilateral GONB (distal approach) of 5 mLs of injectate of bupivacaine 0.25% (5 mLs) + depomedrol 40 mg in 1 mL (3 mLs to each side).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with documented SIH will be recruited from the Toronto Western Hospital Intracranial Hypotension Clinic and enrolled after consent is obtained.

You may qualify if:

• Adults of \> 18 years of age
• Diagnosis of SIH, according to the International Classification of Headache Disorder (ICHD-3) classification (2)
• Characteristics of pain:
• Baseline pain intensity NRS \> 4/10 (in upright position)

You may not qualify if:

• Contraindications to GONB: ongoing infection (systemic or located at the site of injection), intake of anticoagulants (not aspirin), allergy to injectate, contra-indication to injectate of steroids
• Any significant cognitive or language barrier that impedes participation
• Patients taking opioid medications with daily Oral Morphine Equivalent (OME) of 50 mg or higher
• Patient refusal

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M3A2L8, Canada

RECRUITING

MeSH Terms

Conditions

Intracranial Hypotension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Anna Kalleitner, RN

CONTACT

416-603-5800; Anna.Kalleitner@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)