Nicholas Silver

Non-invasive vagus nerve stimulation for PREVention and Acute treatment of chronic cluster headache (PREVA): A randomised controlled study

Background Chronic cluster headache (CH) is a debilitating disorder for which few well-controlled studies demonstrate effectiveness of available therapies. Non-invasive vagus nerve stimulation (nVNS) was examined as adjunctive prophylactic treatment of chronic CH. Methods PREVA was a prospective, open-label, randomised study that compared adjunctive prophylactic nVNS (n = 48) with standard of care (SoC) alone (control (n = 49)). A two-week baseline phase was followed by a four-week randomised phase (SoC plus nVNS vs control) and a four-week extension phase (SoC plus nVNS). The primary end point was the reduction in the mean number of CH attacks per week. Response rate, abortive medication use and safety/tolerability were also assessed. Results During the randomised phase, individuals in the intent-to-treat population treated with SoC plus nVNS (n = 45) had a significantly greater reduction in the number of attacks per week vs controls (n = 48) (−5.9 vs −2.1, respectively) for a mean therapeutic gain of 3.9 fewer attacks per week (95% CI: 0.5, 7.2; p = 0.02). Higher ≥50% response rates were also observed with SoC plus nVNS (40% (18/45)) vs controls (8.3% (4/48); p < 0.001). No serious treatment-related adverse events occurred. Conclusion Adjunctive prophylactic nVNS is a well-tolerated novel treatment for chronic CH, offering clinical benefits beyond those with SoC.

Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A randomized, double-blind, sham-controlled ACT2 study

Background Clinical observations and results from recent studies support the use of non-invasive vagus nerve stimulation (nVNS) for treating cluster headache (CH) attacks. This study compared nVNS with a sham device for acute treatment in patients with episodic or chronic CH (eCH, cCH). Methods After completing a 1-week run-in period, subjects were randomly assigned (1:1) to receive nVNS or sham therapy during a 2-week double-blind period. The primary efficacy endpoint was the proportion of all treated attacks that achieved pain-free status within 15 minutes after treatment initiation, without rescue treatment. Results The Full Analysis Set comprised 48 nVNS-treated (14 eCH, 34 cCH) and 44 sham-treated (13 eCH, 31 cCH) subjects. For the primary endpoint, nVNS (14%) and sham (12%) treatments were not significantly different for the total cohort. In the eCH subgroup, nVNS (48%) was superior to sham (6%; p < 0.01). No significant differences between nVNS (5%) and sham (13%) were seen in the cCH subgroup. Conclusions Combing both eCH and cCH patients, nVNS was no different to sham. For the treatment of CH attacks, nVNS was superior to sham therapy in eCH but not in cCH. These results confirm and extend previous findings regarding the efficacy, safety, and tolerability of nVNS for the acute treatment of eCH.

EHMTI-0364. Non-invasive vagus nerve stimulation using gammacore® for prevention and acute treatment of chronic cluster headache: report from the randomized phase of the preva study

Neuromodulatory devices offer additional treatment options to refractory pharmacologic intervention for the treatment of chronic cluster headaches (CH). Clinical experience suggests vagus nerve stimulation (VNS) may be beneficial; however, inherent risks are associated with surgical implantation. As such, a need for the development of a non-invasive VNS (nVNS) modality exists.

EHMTI-0363. Quality of life in subjects treated by non-invasive vagus nerve stimulation using gammacore® for the prevention and acute treatment of chronic cluster headache

The debilitating nature of chronic cluster headache (CH) can negatively impact a patients quality of life (QoL). In recent years, non-invasive neuromodulation devices have been of increasing interest for the treatment of CH.

INTERDISCIPLINARY CONSENUS ON THE MANAGEMENT OF IIH IN THE UK

Management of Idiopathic Intracranial Hypertension (IIH) is not standardised. A multidisciplinary Special Interest Group (SIG) was established to develop a uniform investigation and treatment strategy according to disease severity based on current literature and expert consensus. Methods A systematic literature review of “IIH”;“Benign IH” and “pseudotumour cerebri” was followed by a SIG meeting, to identify the population, interventions, controls and outcomes (PICO) questions. Discrepant views were reflected in a questionnaire disseminated though a modified Delphi approach to district general and tertiary hospital interdisciplinary specialists. Results 44/66 questionnaires were returned. 51% would image (CT/MRI) patients with definite papilloedema <24 hrs and 40% would image between 24–48 hrs. In these patients 84% would then proceed to venography (50:50, MRV:CTV), conducted within 48 hrs in 74% respondents.79% never diagnosed IIH in those with a lumbar puncture pressure <25 cm CSF. Referral for neurosurgical intervention was predominantly for visual deterioration (83%) with only 2% referring exclusively for headache management. Neurosurgical procedures varied: 48% ventriculoperitoneal shunting, 33% lumboperitoneal shunting, 5% optic nerve sheath fenestration, 14% other and 0% venous stenting. A consensus on follow-up times, according to papilloedema severity and visual function (perimetry), was obtained. Conclusions Evidence for IIH management is minimal. Consensus on many aspects of management was demonstrated which will help establish a practical guideline.

Bilateral optic disc edema as a presentation of an obstructing spinal plasmacytoma

Purpose To report a rare case of bilateral optic disc edema as presentation of an obstructing spinal plasmacytoma. Methods Case report. Results A 41-year-old healthy man presented with distortion of his peripheral vision for 9 months. He denied headaches or neurologic symptoms. Examination showed bilateral optic disc swelling, radial disc hemorrhages, and absent spontaneous venous pulsations. Brain magnetic resonance imaging (MRI) and magnetic resonance venography were unrevealing. Lumbar puncture showed a normal opening pressure of 19 cm cerebrospinal fluid (CSF). CSF protein was significantly elevated at 3.22 g/L (0.10-0.45 g/L). Spinal MRI with contrast revealed a tumor in the T9 vertebral body extending through the disc spaces into T8 and T10, compressing the spinal cord. Computed tomography-guided biopsy confirmed a spinal plasmacytoma. He received radiotherapy to the spine T7-T11 to reduce spinal cord compression followed by a 6-month course of chemotherapy with dexamethasone, cyclophosphamide, and thalidomide. Disc swelling improved on starting radiotherapy with complete resolution 8 months posttreatment. MRI spine showed reduction of tumor. Conclusions This case highlights the importance of spinal imaging in patients with normal cranial scans and raised CSF protein levels who lack the typical idiopathic intracranial hypertension phenotype.

EHMTI-0373. Adrenal suppression associated with greater occipital nerve and multiple cranial nerve blocks using triamcinolone

Greater Occipital Nerve (GON) and Multiple Cranial Nerve (MCN) blocks using local anaesthetics and corticosteroids have been used to treat various headache syndromes including Trigeminal Autonomic Cephalgias (TAC). We report cases where low cortisol levels have been seen in patients with TAC treated with GON/MCN blocks that included triamcinolone.