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Cluster headache
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| Silberstein et al, 201651 (ACT1) |
Pregnant or lactating History of aneurysm, intracranial hemorrhage, brain tumours, significant head trauma, prolonged QT interval, arrhythmia, ventricular tachycardia or fibrillation, syncope, or seizure; structural intracranial or cervical vascular lesions; cardiovascular disease; uncontrolled hypertension; abnormal baseline electrocardiogram Significant pain disorder Botulinum toxin injections in the past 3 mo; nerve blocks in the past 1 mo Previous cluster headache surgery, bilateral or right cervical vagotomy, carotid endarterectomy, or right vascular neck surgery; electrical device implantation Current use of prophylactic medications for indications other than cluster headache
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| Goadsby et al, 201852 (ACT2) |
Episodice cluster headache and not in a bout at the time of screening Pregnant or nursing Need to begin treatment with oral or injectable steroids; use of medication that might have interfered with the study Lesion, dysesthesia, previous surgery, or abnormal anatomy at the treatment site; history of cranial aneurysm, intracranial hemorrhage, brain tumour, significant head trauma, carotid endarterectomy, vascular neck surgery, or cervical vagotomy Secondary headache or other significant pain condition Abnormal baseline electrocardiogram; known or suspected atherosclerotic cardiovascular disease, severe carotid artery disease, congestive heart failure, known severe coronary artery disease, or recent myocardial infarction; uncontrolled high blood pressure Recent or repeated history of syncope or seizures Implanted electrical and/or neurostimulator device, metal cervical spine hardware, or metallic apparatus near the stimulation site History of substance abuse, addiction, or headache medication overuse or a psychiatric or cognitive condition that may have interfered with the study
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| Tassorelli et al, 201855 (PRESTO) |
History of secondary headache, aneurysm, intracranial hemorrhage, brain tumours, significant head trauma, substance abuse, addiction, syncope, or seizure Significant pain disorder Cardiovascular or cerebrovascular disease; uncontrolled hypertension Psychiatric or cognitive disorders Pregnancy Requiring oral or injectable steroids; botulinum toxin injections in the past 6 mo; head or neck nerve blocks in the past 2 mo; previous migraine prevention surgery Cervical vagotomy, electrical device, or metal cervical spine hardware implantation Current use of opioids for > 2 d per mo; current use of simple analgesics or nonsteroidal anti-inflammatory drugs for > 15 d per mo; current use of triptans, ergots, or combined analgesics for > 10 d per mo; initiation of preventive migraine medications in the past 2 mo
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| Migraine |
| Gaul et al, 201653 (PREVA) |
Change in prophylactic medication type or dosage < 1 mo before enrolment History of intracranial or carotid aneurysm or hemorrhage; brain tumours or lesions; signficant head trauma, surgery, or abnormal anatomy at the nVNS treatment site; history of syncope or seizures Known or suspected cardiac or cardiovascular disease Implantatation with electrical or neurostimulation devices; history of carotid endarterectomy or vascular neck surgery; implantation with metallic hardware
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| Silberstein et al, 201656 (EVENT) |
History of aneurysm, intracranial hemorrhage, brain tumour, or head trauma; a lesion, dysesthesia, previous surgery, or abnormal anatomy at the treatment site Cardiovascular disease; uncontrolled hypertension; abnormal electrocardiogram results; recent myocardial infarction Implanted electrical or neurostimulator device; a metallic implant or metal cervical spine hardware near the stimulation site Previous surgery for migraine prevention; onabotulinumtoxin A injections for migraine prevention within 6 mo; prophylactic migraine medication within 30 d
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| Chaudhry et al, 201959
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Concomitant neuropsychiatric comorbidity not adequately classified and/or requiring specific diagnosis or treatment Pregnancy Previously performed invasive, noninvasive, and ablative procedures Intracranial and cervical pathologies Medication overuse headache
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| Diener et al, 201957 (PREMIUM) |
Chronic migraine diagnosis; previous diagnosis of medication overuse headache that had reverted to episodic migraine in the past 6 mo Medical condition requiring oral or injectable steroids History of secondary headache, aneurysm, intracranial haemorrhage, brain tumours, significant head trauma, substance abuse, addiction, syncope, or seizure Structural abnormality, pain, or metal cervical spine hardware implantation near treatment site Significant pain disorder Cardiovascular or cerebrovascular disease; abnormal electrocardiogram; uncontrolled hypertension Previous migraine prevention surgery, cervical vagotomy, or electrical or neurostimulator device implantation Psychiatric or cognitive disorders; pregnancy Botulinum toxin injections in the past 6 mo; head or neck nerve blocks in the past 2 mo; failure of at least 3 classes of migraine prevention drugs; opioid use; marijuana use; simple analgesic or nonsteroidal anti-inflammatory drug use (> 15 d per mo); or triptan, ergot, or combined analgesic use (> 10 d per mo) Use of preventive migraine treatments at or within 30 d of baseline
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| Najib et al, 202258 (PREMIUM II) |
On 2 or more preventive therapies, injections of onabotulinumtoxin A or calcitonin gene-related peptide-targeting monoclonal antibody drugs within the last 6 mo Takes simple analgesics or nonsteroidal anti-inflammatory drugs > 15 d per mo or triptans, ergots, or combined analgesics > 10 d per mo; prescription opioids more than 2 d per mo Surgery for migraine prevention; undergone nerve block in head or neck within the last 3 mo Medication overuse headache that had reverted to migraine, history of secondary headache disorder History of intracranial aneurysm, intracranial hemorrhage, brain tumour, or significant head trauma Structural abnormality or pain at the nVNS treatment site; previous cervical vagotomy; implanted with an electrical and/or neurostimulator device or metal cervical spine hardware or has a metallic implant near the nVNS stimulation site Other significant pain problem Severe cardiac disease, cerebrovascular disease, abnormal electrocardiogram within the last year; uncontrolled high blood pressure; history of syncope, seizure History of substance abuse or addiction; currently using marijuana Pregnant or thinking of becoming pregnant Psychiatric or cognitive disorder and/or behavioural problems that may interfere with the study
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