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Ludvic Zrinzo - One of the best experts on this subject based on the ideXlab platform.

  • WP1-1 Sphenopalatine ganglion stimulation for Chronic Cluster Headache
    Journal of Neurology Neurosurgery & Psychiatry, 2019
    Co-Authors: Sarah Miller, Manjit Matharu, Susie Lagrata, Ludvic Zrinzo
    Abstract:

    Objectives To assess outcome of sphenopalatine ganglion stimulation (SPGS) in Chronic Cluster Headache (CCH) in a UK centre. Design Uncontrolled open-label single centre prospective study. Subjects Nine patients with medically refractory CCH. Methods Participants underwent sphenopalatine ganglion stimulator implantation, ipsilateral to CCH symptoms via a gingival incision, with fluoroscopy guidance and dyna-CT confirmation of contact location adjacent to the Vidian canal in the pterygopalatine fossa. One month after surgery, the device was programmed. Patients were instructed to provide stimulation as early as possible after attack onset and at least twice daily. The primary outcome was change in Headache frequency as well as adverse events. Results Mean follow up was 14 months (SD 11.1, range: 3–31) with median reduction in Headache frequency at last follow up of 73% (IQR: 67%–88%). At 3 months post op, 4/9 (45%) had at least 50% reduction in frequency of attacks; this increased to 8/9 patients (89%) at last follow up. Two patients became pain free (after 3 and 9 months). Preventative effects were seen in 7/9 and an acute effect in 2/9. One patient suffered numbness over the V2 distribution and did not respond to SPGS. The stimulator was removed 1 year later at the patient’s request. One wound infection settled with oral antibiotics. Conclusions Initial data from the UK confirms the results from previous studies and compares well with the results of occipital nerve stimulation for CCH.

  • Author response: Optimal deep brain stimulation site and target connectivity for Chronic Cluster Headache.
    Neurology, 2018
    Co-Authors: Harith Akram, Manjit Matharu, Ludvic Zrinzo
    Abstract:

    We thank Dr. Gupta for his interest in our article.1 Dr. Gupta suggests that a trial of high-dose indomethacin should be considered for patients with Chronic Cluster Headache (CCH). Whether patients with a phenotype of Cluster Headache (CH), who respond to indomethacin, should be classified as having paroxysmal hemicrania (PH) or indomethacin-responsive CH is unclear. Furthermore, these sparse case reports of indomethacin-responsive CH may be due to a placebo response.2 Headache disorders with the clinical phenotype of either PH or CH that respond to indomethacin should be classified as PH for now, until the pathophysiology of these disorders is better understood.

  • Optimal deep brain stimulation site and target connectivity for Chronic Cluster Headache.
    Neurology, 2017
    Co-Authors: Harith Akram, Sarah Miller, Manjit Matharu, Susie Lagrata, Marwan Hariz, John Ashburner, Timothy E.j. Behrens, Ludvic Zrinzo
    Abstract:

    Objective: To investigate the mechanism of action of deep brain stimulation for refractory Chronic Cluster Headache and the optimal target within the ventral tegmental area. Methods: Seven patients ...

  • Ventral tegmental area deep brain stimulation for refractory Chronic Cluster Headache.
    Neurology, 2016
    Co-Authors: Harith Akram, Sarah Miller, Manjit Matharu, Susie Lagrata, Marwan Hariz, Jonathan A. Hyam, Marjan Jahanshahi, Ludvic Zrinzo
    Abstract:

    Objective: To present outcomes in a cohort of medically intractable Chronic Cluster Headache (CCH) patients treated with ventral tegmental area (VTA) deep brain stimulation (DBS). Methods: In an uncontrolled open-label prospective study, 21 patients (17 male; mean age 52 years) with medically refractory CCH were selected for ipsilateral VTA-DBS by a specialist multidisciplinary team including a Headache neurologist and functional neurosurgeon. Patients had also failed or were denied access to occipital nerve stimulation within the UK National Health Service. The primary endpoint was improvement in the Headache frequency. Secondary outcomes included other Headache scores (severity, duration, Headache load), medication use, disability and affective scores, quality of life (QoL) measures, and adverse events. Results: Median follow-up was 18 months (range 4–60 months). At the final follow-up point, there was 60% improvement in Headache frequency ( p = 0.007) and 30% improvement in Headache severity ( p = 0.001). The Headache load (a composite score encompassing frequency, severity, and duration of attacks) improved by 68% ( p = 0.002). Total monthly triptan intake of the group dropped by 57% posttreatment. Significant improvement was observed in a number of QoL, disability, and mood scales. Side effects included diplopia, which resolved in 2 patients following stimulation adjustment, and persisted in 1 patient with a history of ipsilateral trochlear nerve palsy. There were no other serious adverse events. Conclusions: This study supports that VTA-DBS may be a safe and effective therapy for refractory CCH patients who failed conventional treatments. Classification of evidence: This study provides Class IV evidence that VTA-DBS decreases Headache frequency, severity, and Headache load in patients with medically intractable Chronic Cluster Headaches.

  • EHMTI-0279. Deep brain stimulation for refractory Chronic Cluster Headache
    Journal of Headache and Pain, 2014
    Co-Authors: Sarah Miller, Manjit Matharu, Harith Akram, Susie Lagrata, Marwan Hariz, Ludvic Zrinzo
    Abstract:

    Chronic Cluster Headache (CCH) is an excruciating, unilateral Headache with recurrent episodes of severe pain associated with ipsilateral autonomic features. 10-20% of patients are refractory to medical management. We present a prospective cohort of 19 patients with intractable CCH treated with posterior hypothalamic deep brain stimulation (DBS).

Manjit Matharu - One of the best experts on this subject based on the ideXlab platform.

  • open label multi dose pilot safety study of injection of onabotulinumtoxina toward the otic ganglion for the treatment of intractable Chronic Cluster Headache
    Headache, 2020
    Co-Authors: Joan Crespi, David W. Dodick, Manjit Matharu, Daniel Fossum Bratbak, Ole Solheim, Sasha Gulati, Erik Magnus Berntsen, Erling Tronvik
    Abstract:

    Background The otic ganglion (OG) provides parasympathetic innervation to the cerebral circulation and cranial structures and may be involved in the pathophysiology of trigeminal autonomic Headaches. This structure has never been targeted in any Headache disorder. Objective To investigate the safety of injecting onabotulinumtoxin A (BTA) toward the OG in 10 patients with intractable Chronic Cluster Headache and to collect efficacy data. Methods A total of 10 patients with Chronic Cluster Headache were enrolled in this open-label, multi-dose pilot safety study. All patients were recruited and treated on an out-patient basis at St Olav's University Hospital (Norway). In 5 patients each, the OG was the injection target with 12.5 IU of BTA or 25 IU, respectively. The primary outcome measure was adverse events (AEs) and the main secondary outcome was the number of attacks per week measured at baseline and in the second month following injection. Results For the primary endpoint, we analyzed data for all 10 patients. There were a total of 17 AEs in 6 of the 10 patients. All AEs were considered mild and disappeared by the end of follow-up. The median number of attacks per week at baseline was 17.0 [7.8 to 25.8] vs 14.0 [7.3 to 20.0] in the second month following injection; difference: 3 (95%CI: -0.3 to 7.9), P = .063. Conclusions Injection with BTA toward the OG appears to be safe. We did not find a statistically significant reduction in the number of attacks per week at month 2 after injection compared to the baseline. This study suggests that the OG is not an important target for the treatment of Chronic Cluster Headache. A future study employing more precise targeting of the OG may be indicated.

  • Open‐Label, Multi‐Dose, Pilot Safety Study of Injection of OnabotulinumtoxinA Toward the Otic Ganglion for the Treatment of Intractable Chronic Cluster Headache
    Headache, 2020
    Co-Authors: Joan Crespi, David W. Dodick, Manjit Matharu, Daniel Fossum Bratbak, Ole Solheim, Sasha Gulati, Erik Magnus Berntsen, Erling Tronvik
    Abstract:

    Background The otic ganglion (OG) provides parasympathetic innervation to the cerebral circulation and cranial structures and may be involved in the pathophysiology of trigeminal autonomic Headaches. This structure has never been targeted in any Headache disorder. Objective To investigate the safety of injecting onabotulinumtoxin A (BTA) toward the OG in 10 patients with intractable Chronic Cluster Headache and to collect efficacy data. Methods A total of 10 patients with Chronic Cluster Headache were enrolled in this open-label, multi-dose pilot safety study. All patients were recruited and treated on an out-patient basis at St Olav's University Hospital (Norway). In 5 patients each, the OG was the injection target with 12.5 IU of BTA or 25 IU, respectively. The primary outcome measure was adverse events (AEs) and the main secondary outcome was the number of attacks per week measured at baseline and in the second month following injection. Results For the primary endpoint, we analyzed data for all 10 patients. There were a total of 17 AEs in 6 of the 10 patients. All AEs were considered mild and disappeared by the end of follow-up. The median number of attacks per week at baseline was 17.0 [7.8 to 25.8] vs 14.0 [7.3 to 20.0] in the second month following injection; difference: 3 (95%CI: -0.3 to 7.9), P = .063. Conclusions Injection with BTA toward the OG appears to be safe. We did not find a statistically significant reduction in the number of attacks per week at month 2 after injection compared to the baseline. This study suggests that the OG is not an important target for the treatment of Chronic Cluster Headache. A future study employing more precise targeting of the OG may be indicated.

  • WP1-1 Sphenopalatine ganglion stimulation for Chronic Cluster Headache
    Journal of Neurology Neurosurgery & Psychiatry, 2019
    Co-Authors: Sarah Miller, Manjit Matharu, Susie Lagrata, Ludvic Zrinzo
    Abstract:

    Objectives To assess outcome of sphenopalatine ganglion stimulation (SPGS) in Chronic Cluster Headache (CCH) in a UK centre. Design Uncontrolled open-label single centre prospective study. Subjects Nine patients with medically refractory CCH. Methods Participants underwent sphenopalatine ganglion stimulator implantation, ipsilateral to CCH symptoms via a gingival incision, with fluoroscopy guidance and dyna-CT confirmation of contact location adjacent to the Vidian canal in the pterygopalatine fossa. One month after surgery, the device was programmed. Patients were instructed to provide stimulation as early as possible after attack onset and at least twice daily. The primary outcome was change in Headache frequency as well as adverse events. Results Mean follow up was 14 months (SD 11.1, range: 3–31) with median reduction in Headache frequency at last follow up of 73% (IQR: 67%–88%). At 3 months post op, 4/9 (45%) had at least 50% reduction in frequency of attacks; this increased to 8/9 patients (89%) at last follow up. Two patients became pain free (after 3 and 9 months). Preventative effects were seen in 7/9 and an acute effect in 2/9. One patient suffered numbness over the V2 distribution and did not respond to SPGS. The stimulator was removed 1 year later at the patient’s request. One wound infection settled with oral antibiotics. Conclusions Initial data from the UK confirms the results from previous studies and compares well with the results of occipital nerve stimulation for CCH.

  • Author response: Optimal deep brain stimulation site and target connectivity for Chronic Cluster Headache.
    Neurology, 2018
    Co-Authors: Harith Akram, Manjit Matharu, Ludvic Zrinzo
    Abstract:

    We thank Dr. Gupta for his interest in our article.1 Dr. Gupta suggests that a trial of high-dose indomethacin should be considered for patients with Chronic Cluster Headache (CCH). Whether patients with a phenotype of Cluster Headache (CH), who respond to indomethacin, should be classified as having paroxysmal hemicrania (PH) or indomethacin-responsive CH is unclear. Furthermore, these sparse case reports of indomethacin-responsive CH may be due to a placebo response.2 Headache disorders with the clinical phenotype of either PH or CH that respond to indomethacin should be classified as PH for now, until the pathophysiology of these disorders is better understood.

  • Optimal deep brain stimulation site and target connectivity for Chronic Cluster Headache.
    Neurology, 2017
    Co-Authors: Harith Akram, Sarah Miller, Manjit Matharu, Susie Lagrata, Marwan Hariz, John Ashburner, Timothy E.j. Behrens, Ludvic Zrinzo
    Abstract:

    Objective: To investigate the mechanism of action of deep brain stimulation for refractory Chronic Cluster Headache and the optimal target within the ventral tegmental area. Methods: Seven patients ...

Sarah Miller - One of the best experts on this subject based on the ideXlab platform.

  • WP1-1 Sphenopalatine ganglion stimulation for Chronic Cluster Headache
    Journal of Neurology Neurosurgery & Psychiatry, 2019
    Co-Authors: Sarah Miller, Manjit Matharu, Susie Lagrata, Ludvic Zrinzo
    Abstract:

    Objectives To assess outcome of sphenopalatine ganglion stimulation (SPGS) in Chronic Cluster Headache (CCH) in a UK centre. Design Uncontrolled open-label single centre prospective study. Subjects Nine patients with medically refractory CCH. Methods Participants underwent sphenopalatine ganglion stimulator implantation, ipsilateral to CCH symptoms via a gingival incision, with fluoroscopy guidance and dyna-CT confirmation of contact location adjacent to the Vidian canal in the pterygopalatine fossa. One month after surgery, the device was programmed. Patients were instructed to provide stimulation as early as possible after attack onset and at least twice daily. The primary outcome was change in Headache frequency as well as adverse events. Results Mean follow up was 14 months (SD 11.1, range: 3–31) with median reduction in Headache frequency at last follow up of 73% (IQR: 67%–88%). At 3 months post op, 4/9 (45%) had at least 50% reduction in frequency of attacks; this increased to 8/9 patients (89%) at last follow up. Two patients became pain free (after 3 and 9 months). Preventative effects were seen in 7/9 and an acute effect in 2/9. One patient suffered numbness over the V2 distribution and did not respond to SPGS. The stimulator was removed 1 year later at the patient’s request. One wound infection settled with oral antibiotics. Conclusions Initial data from the UK confirms the results from previous studies and compares well with the results of occipital nerve stimulation for CCH.

  • Optimal deep brain stimulation site and target connectivity for Chronic Cluster Headache.
    Neurology, 2017
    Co-Authors: Harith Akram, Sarah Miller, Manjit Matharu, Susie Lagrata, Marwan Hariz, John Ashburner, Timothy E.j. Behrens, Ludvic Zrinzo
    Abstract:

    Objective: To investigate the mechanism of action of deep brain stimulation for refractory Chronic Cluster Headache and the optimal target within the ventral tegmental area. Methods: Seven patients ...

  • Treatment of intractable Chronic Cluster Headache by occipital nerve stimulation: a cohort of 51 patients
    European journal of neurology, 2016
    Co-Authors: Sarah Miller, Laurence D. Watkins, Manjit Matharu
    Abstract:

    Background and purpose Chronic Cluster Headache is a rare, highly disabling primary Headache condition. When medically intractable, occipital nerve stimulation can offer effective treatment. Open-label series have provided data on small cohorts only. Methods We analyzed 51 subjects to evaluate the long-term outcomes of highly intractable Chronic Cluster Headache with occipital nerve stimulation. Patients with intractable Chronic Cluster Headache were implanted with occipital nerve stimulators during the period 2007–2014. The primary endpoint was improvement in daily attack frequency. Secondary endpoints included attack severity, attack duration, quality-of-life measures, Headache disability scores and adverse events. Results We studied 51 patients [35 males; mean age at implant 47.78 (range 31–70) years; mean follow-up 39.17 (range 2–81) months]. Nineteen patients had other Chronic Headache types in addition in Chronic Cluster Headache. At final follow-up, there was a 46.1% improvement in attack frequency (P < 0001) across all patients, 49.5% (P < 0.001) in those with Cluster Headache alone and 40.3% (P = 0.036) in those with multiple phenotypes. There were no significant differences in response in those with or without multiple Headache types. The overall response rate (defined as at least a 50% improvement in attack frequency) was 52.9%. Significant reductions were also seen in attack duration and severity. Improvements were noted in Headache disability scores and quality-of-life measures. Triptan use of responders dropped by 62.56%, resulting in significant cost savings. Adverse event rates were highly favorable. Conclusion Occipital nerve stimulation appears to be a safe and efficacious treatment for highly intractable Chronic Cluster Headache even after a mean follow-up of over 3 years.

  • Ventral tegmental area deep brain stimulation for refractory Chronic Cluster Headache.
    Neurology, 2016
    Co-Authors: Harith Akram, Sarah Miller, Manjit Matharu, Susie Lagrata, Marwan Hariz, Jonathan A. Hyam, Marjan Jahanshahi, Ludvic Zrinzo
    Abstract:

    Objective: To present outcomes in a cohort of medically intractable Chronic Cluster Headache (CCH) patients treated with ventral tegmental area (VTA) deep brain stimulation (DBS). Methods: In an uncontrolled open-label prospective study, 21 patients (17 male; mean age 52 years) with medically refractory CCH were selected for ipsilateral VTA-DBS by a specialist multidisciplinary team including a Headache neurologist and functional neurosurgeon. Patients had also failed or were denied access to occipital nerve stimulation within the UK National Health Service. The primary endpoint was improvement in the Headache frequency. Secondary outcomes included other Headache scores (severity, duration, Headache load), medication use, disability and affective scores, quality of life (QoL) measures, and adverse events. Results: Median follow-up was 18 months (range 4–60 months). At the final follow-up point, there was 60% improvement in Headache frequency ( p = 0.007) and 30% improvement in Headache severity ( p = 0.001). The Headache load (a composite score encompassing frequency, severity, and duration of attacks) improved by 68% ( p = 0.002). Total monthly triptan intake of the group dropped by 57% posttreatment. Significant improvement was observed in a number of QoL, disability, and mood scales. Side effects included diplopia, which resolved in 2 patients following stimulation adjustment, and persisted in 1 patient with a history of ipsilateral trochlear nerve palsy. There were no other serious adverse events. Conclusions: This study supports that VTA-DBS may be a safe and effective therapy for refractory CCH patients who failed conventional treatments. Classification of evidence: This study provides Class IV evidence that VTA-DBS decreases Headache frequency, severity, and Headache load in patients with medically intractable Chronic Cluster Headaches.

  • EHMTI-0279. Deep brain stimulation for refractory Chronic Cluster Headache
    Journal of Headache and Pain, 2014
    Co-Authors: Sarah Miller, Manjit Matharu, Harith Akram, Susie Lagrata, Marwan Hariz, Ludvic Zrinzo
    Abstract:

    Chronic Cluster Headache (CCH) is an excruciating, unilateral Headache with recurrent episodes of severe pain associated with ipsilateral autonomic features. 10-20% of patients are refractory to medical management. We present a prospective cohort of 19 patients with intractable CCH treated with posterior hypothalamic deep brain stimulation (DBS).

Nagy Mekhail - One of the best experts on this subject based on the ideXlab platform.

  • sphenopalatine ganglion radiofrequency ablation for the management of Chronic Cluster Headache
    Headache, 2009
    Co-Authors: Samer Narouze, Leonardo Kapural, Jose Casanova, Nagy Mekhail
    Abstract:

    Objectives.— Chronic Cluster Headache patients are often resistant to pharmacological management. Percutaneous radiofrequency ablation (RFA) of the sphenopalatine ganglion (SPG) was shown before to improve episodic Cluster Headache but not Chronic Cluster Headache. We were interested to examine the effect of such intervention in patients with intractable Chronic Cluster Headache who failed pharmacological management. Methods.— Fifteen patients with Chronic Cluster Headache, who experienced temporary pain relief following SPG block, underwent percutaneous RFA via the infrazygomatic approach under fluoroscopic guidance. Collected data include demographic variables, onset and duration of the Headache, mean attack intensity (MAI), mean attack frequency (MAF), and pain disability index (PDI) before and up to 18 months after procedure. Results.— At 1-, 3-, 6-, 12-, 18-month follow-up, the MAI was 2.6, 3.2, 3.2, 3.4, 4.2, respectively (P < .0001, P < .0001, P < .0001, P < .0005, P < .003, respectively). The PDI improved from 55 (baseline) to 17.2 and 25.6 at 6 and 12 months respectively (P < .001). The MAF improved from 17 attacks/week to 5.4, 6.4, 7.8, 8.6, 8.3 at 1-, 3-, 6-, 12-, 18-month follow-up visits (P < .0001, P < .0001, P < .0001, P < .002, P < .004, respectively). Conclusion.— Our data showed that percutaneous RFA of the SPG is an effective modality of treatment for patients with intractable Chronic Cluster Headaches. Precise needle placement with the use of real-time fluoroscopy and electrical stimulation prior to attempting radiofrequency lesioning may reduce the incidence of adverse events.

  • Sphenopalatine ganglion radiofrequency ablation for the management of Chronic Cluster Headache.
    Headache, 2008
    Co-Authors: Samer Narouze, Leonardo Kapural, Jose Casanova, Nagy Mekhail
    Abstract:

    Objectives.— Chronic Cluster Headache patients are often resistant to pharmacological management. Percutaneous radiofrequency ablation (RFA) of the sphenopalatine ganglion (SPG) was shown before to improve episodic Cluster Headache but not Chronic Cluster Headache. We were interested to examine the effect of such intervention in patients with intractable Chronic Cluster Headache who failed pharmacological management. Methods.— Fifteen patients with Chronic Cluster Headache, who experienced temporary pain relief following SPG block, underwent percutaneous RFA via the infrazygomatic approach under fluoroscopic guidance. Collected data include demographic variables, onset and duration of the Headache, mean attack intensity (MAI), mean attack frequency (MAF), and pain disability index (PDI) before and up to 18 months after procedure. Results.— At 1-, 3-, 6-, 12-, 18-month follow-up, the MAI was 2.6, 3.2, 3.2, 3.4, 4.2, respectively (P 

Charly Gaul - One of the best experts on this subject based on the ideXlab platform.

  • Supplemental material for Changes in medication cost observed in Chronic Cluster Headache patients treated with sphenopalatine ganglion (SPG) stimulation: Analysis based on 1-year data from the Pathway R-1 Registry
    2018
    Co-Authors: Jan B Pietzsch, Simon A Weber, Nunu Lund, Charly Gaul
    Abstract:

    Supplemental material for Changes in medication cost observed in Chronic Cluster Headache patients treated with sphenopalatine ganglion (SPG) stimulation: Analysis based on 1-year data from the Pathway R-1 Registry by Jan B Pietzsch, Simon A Weber, Nunu Lund and Charly Gaul in Cephalalgia

  • effects of non invasive vagus nerve stimulation on attack frequency over time and expanded response rates in patients with Chronic Cluster Headache a post hoc analysis of the randomised controlled preva study
    Journal of Headache and Pain, 2017
    Co-Authors: Charly Gaul, Delphine Magis, Eric Liebler, A Straube
    Abstract:

    In the PREVention and Acute treatment of Chronic Cluster Headache (PREVA) study, attack frequency reductions from baseline were significantly more pronounced with non-invasive vagus nerve stimulation plus standard of care (nVNS + SoC) than with SoC alone. Given the intensely painful and frequent nature of Chronic Cluster Headache attacks, additional patient-centric outcomes, including the time to and level of therapeutic response, were evaluated in a post hoc analysis of the PREVA study. After a 2-week baseline phase, 97 patients with Chronic Cluster Headache entered a 4-week randomised phase to receive nVNS + SoC (n = 48) or SoC alone (n = 49). All 92 patients who continued into a 4-week extension phase received nVNS + SoC. Compared with SoC alone, nVNS + SoC led to a significantly lower mean weekly attack frequency by week 2 of the randomised phase; the attack frequency remained significantly lower in the nVNS + SoC group through week 3 of the extension phase (P < 0.02). Attack frequencies in the nVNS + SoC group were significantly lower at all study time points than they were at baseline (P < 0.05). Response rates were significantly greater with nVNS + SoC than with SoC alone when response was defined as attack frequency reductions of ≥25%, ≥50%, and ≥75% from baseline (≥25% and ≥50%, P < 0.001; ≥75%, P = 0.009). The 100% response rate was 8% with nVNS + SoC and 0% with SoC alone. Prophylactic nVNS led to rapid, significant, and sustained reductions in Chronic Cluster Headache attack frequency within 2 weeks after its addition to SoC and was associated with significantly higher ≥25%, ≥50%, and ≥75% response rates than SoC alone. The rapid decrease in weekly attack frequency justifies a 4-week trial period to identify responders to nVNS, with a high degree of confidence, among patients with Chronic Cluster Headache.

  • Effects of non-invasive vagus nerve stimulation on attack frequency over time and expanded response rates in patients with Chronic Cluster Headache: a post hoc analysis of the randomised, controlled PREVA study.
    The journal of headache and pain, 2017
    Co-Authors: Charly Gaul, Delphine Magis, Eric Liebler, A Straube
    Abstract:

    In the PREVention and Acute treatment of Chronic Cluster Headache (PREVA) study, attack frequency reductions from baseline were significantly more pronounced with non-invasive vagus nerve stimulation plus standard of care (nVNS + SoC) than with SoC alone. Given the intensely painful and frequent nature of Chronic Cluster Headache attacks, additional patient-centric outcomes, including the time to and level of therapeutic response, were evaluated in a post hoc analysis of the PREVA study. After a 2-week baseline phase, 97 patients with Chronic Cluster Headache entered a 4-week randomised phase to receive nVNS + SoC (n = 48) or SoC alone (n = 49). All 92 patients who continued into a 4-week extension phase received nVNS + SoC. Compared with SoC alone, nVNS + SoC led to a significantly lower mean weekly attack frequency by week 2 of the randomised phase; the attack frequency remained significantly lower in the nVNS + SoC group through week 3 of the extension phase (P 

  • 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
    Journal of Headache and Pain, 2014
    Co-Authors: Charly Gaul, Hans-christoph Diener, Delphine Magis, A Straube, K. Solbach, Nicholas Silver, Uwe Reuter, A Andersson, Eric Liebler
    Abstract:

    The debilitating nature of Chronic Cluster Headache (CH) can negatively impact a patient's quality of life (QoL). In recent years, non-invasive neuromodulation devices have been of increasing interest for the treatment of CH.

  • Occipital nerve stimulation for intractable Chronic Cluster Headache or migraine: A critical analysis of direct treatment costs and complications:
    Cephalalgia : an international journal of headache, 2013
    Co-Authors: Oliver Mueller, Hans-christoph Diener, Philipp Dammann, Kasja Rabe, Vincent Hagel, Ulrich Sure, Charly Gaul
    Abstract:

    BackgroundOccipital nerve stimulation (ONS) has been shown to be effective for selected patients with intractable Headache disorders. We performed a prospective critical evaluation of complications and direct treatment costs.MethodsTwenty-seven patients with Chronic Cluster Headache (CCH, n = 24) or Chronic migraine (CM, n = 3) underwent a trial phase with bilateral ONS and subsequent implantation of a permanent generator (IPG), if responsive to treatment according to predefined criteria. Procedural and long-term complications as well as direct treatment costs of neuromodulation therapy of ONS were recorded over a mean follow-up period of 20 months (range 5–47 months).ResultsTwenty-five of 27 patients (93%) responded to treatment. Twenty-one complications in 14 patients were identified, necessitating reoperation in 13 cases. Overall treatment costs were €761,043, including hardware-related costs of €506,019, costs for primary hospital care of €210,496, and complications related to hospitalization costs of...