Research

Spontaneous Intracranial Hypotension Registry (Actively Recruiting)

Background and Purpose:

The objective of this research study is to develop a geographic database or registry to collect data on SIH patients from all physicians in the Calgary area. We are hoping that the SIH registry will improve our understanding of the epidemiology, diagnosis, clinical characteristics, useful imaging modalities, treatments & management, prognosis and natural history of SIH. This study requires minimal patient participation as the data will be collected from patients’ medical records.

Inclusion Criteria:

• Patients aged 18 and older
• Patients must meet ICDH-III diagnostic criteria for SIH in order to avoid contamination of registry with other mimicking headache disorders. The criteria are as follows: 

          A.    Any headache fulfilling criterion B to D

          B.    Low CSF pressure (<60 mm) and/or evidence of CSF leakage (direct or indirect) on imaging

          C.    Headache has developed in temporal relation to low CSF pressure or CSF leakage, or has led to its discovery

          D.    Not better accounted by another ICHD-III diagnosis

• Patients registered in clinics and hospitals within Alberta Health Services

Exclusion Criteria:

• Patients with a clear history of moderate to severe trauma leading to a CSF leak. Patients with minor trauma can be included
• Headache attributed to post-dural puncture headache
• Presence of other headache disorders that may complicate the picture, such as post-traumatic headache, medication-overuse headache, and orthostatic headache not due to SIH

Efficacy and Safety of Occipital Nerve Stimulation in Trigeminal Autonomic Cephalalgias: A double-blind, phase II, randomized, controlled trial (Actively Recruiting)

Background and Purpose:

This is a double-blind clinical trial looking at the efficacy of occipital nerve stimulation in the treatment of trigeminal autonomic cephalalgias.

Inclusion Criteria:

• Meets ICHD-3 diagnostic criteria for the chronic form of one of the trigeminal autonomic cephalgias, as determined by the treating headache neurologist.
• Meets psychological requirements for implantation of a neuromodulation device for pain, meaning the absence of uncontrolled or untreated psychiatric disease, as determined by the treating psychiatrist. (Assessment by Dr. Aaron Mackie is required before referral)
• Failed standard medical management, meaning at least 3 conventional preventative therapies. These include:
  1. Cluster headache: verapamil, lithium, topiramate, divalproex, melatonin, Emgality, etc. (note that oxygen is not a preventative)
  2. SUNCT/SUNA: lamotrigine, gabapentin, pregabalin, carbamazepine, tricyclic antidepressants, etc.
  3. Hemicrania continua: indomethacin, verapamil, gabapentin, etc.
• On stable dose of preventative medications for a minimum of 2 months prior to screening visit, with no plan to change these medications, and no occipital nerve blocks or botox injections or steroids for minimum of 3 months prior.
  1. Acute/abortive medications, such as oxygen or triptans, are allowed
  2. Note that occipital nerve blocks and steroids and botox injections are not allowed during the 6 month blinded phase
• No medical contraindications to surgeryPatients aged 18 and older

Exclusion Criteria:

• Presence of another headache disorder
• Presence of uncontrolled or untreated psychiatric disease
• Presence of medical contraindications to surgery
• Non-English speaking

Recruitment:

If you have a patient that fits the criteria, and they are willing to explore the option of surgery to treat their headache, please let both Drs. Girgis and Amoozegar know of the patient

Cannabis for the Prophylactic Treatment of Migraine: a Randomized Double-Blind Placebo-Controlled Clinical Trial

Purpose:

The purpose of this study is to evaluate the efficacy and safety of a high CBD/low THC capsule for the treatment of chronic migraine.

Study participants will be randomized to one of three groups: placebo, low dose CBD (100 mg OD) or high dose CBD (200 mg OD).

Inclusion Criteria:

• Patients aged 25 and older
• History of migraine for at least 12 months
• Chronic migraine for at least 3 months prior to screening
• Migraine preventative medications (including Botulinum toxin injections) are permitted if dose is stable for the 3 month period prior to randomization (and for 3 cycles of Botulinum toxin injections), and no change to dose is planned for the entire duration of the study
• Failure of at least 2 prior migraine preventatives, either due to lack of efficacy with an appropriate trial of the medication, or due to lack of tolerability

Exclusion Criteria:

• Other active primary headaches, such as cluster headache, hemicrania continua, etc.
• Pregnant, planning to become pregnant, or breastfeeding.
• Active or significant history of major mental illness, including severe depression, or anxiety, and any history of psychosis or schizophrenia.
• Regular use of cannabis (weekly or more frequent), for medical or recreational reasons during the previous 3 months.  Patients will also not be permitted to use cannabis or any cannabis products for the full duration of the study.
• History of significant cardiovascular or cerebrovascular disease or hypertension greater than 160/100 and not medically treated
• Overuse of triptan, dihydroergotamine, opioid, or barbiturate medications, defined as 10 or more days per month in the 3 months prior to randomization.
• Overuse of simple analgesics (such as acetaminophen, ibuprofen, aspirin), and non-steroidal anti-inflammatories (such as naproxen, ketorolac, diclofenac, etc.) defined as 15 or more days per month in the 3 months prior to randomization.

Study involves:

• Treatment with cannabis in a capsule or placebo
• Up to 6 visits to the CHAMP clinic at South Health Campus over 28 weeks
• Medical assessments including physical exam, ECG and lab work
• Headache tracking with an e-diary

Recruitment and Status:

• Actively Recruiting, started 2026-April
• https://clinicaltrials.gov/study/NCT03972124?term=Chronic%20Migraine%20AND%20Cannabis&rank=2