scholarly journals Long-term effectiveness of sphenopalatine ganglion stimulation for cluster headache

Cephalalgia ◽  
2016 ◽  
Vol 37 (5) ◽  
pp. 423-434 ◽  
Author(s):  
Tim P Jürgens ◽  
Mads Barloese ◽  
Arne May ◽  
Jose Miguel Láinez ◽  
Jean Schoenen ◽  
...  
Keyword(s):  
Cluster Headache ◽  
Response To Therapy ◽  
Sphenopalatine Ganglion ◽  
Attack Frequency ◽  
Open Label ◽  
Acute Therapy ◽  
Medical Treatments ◽  
Term Data

Objectives The sphenopalatine ganglion (SPG) plays a pivotal role in cluster headache (CH) pathophysiology as the major efferent parasympathetic relay. We evaluated the long-term effectiveness of SPG stimulation in medically refractory, chronic CH patients. Methods Thirty-three patients were enrolled in an open-label follow-up study of the original Pathway CH-1 study, and participated through 24 months post-insertion of a microstimulator. Response to therapy was defined as acute effectiveness in ≥ 50% of attacks or a ≥ 50% reduction in attack frequency versus baseline. Results In total, 5956 attacks (180.5 ± 344.8, range 2–1581 per patient) were evaluated. At 24 months, 45% ( n = 15) of patients were acute responders. Among acute responders, a total of 4340 attacks had been treated, and in 78% of these, effective therapy was achieved using only SPG stimulation (relief from moderate or greater pain or freedom from mild pain or greater). A frequency response was observed in 33% ( n = 11) of patients with a mean reduction of attack frequency of 83% versus baseline. In total, 61% (20/33) of all patients were either acute or frequency responders or both. The majority maintained their therapeutic response through the 24-month evaluation. Conclusions In the population of disabled, medically refractory chronic CH patients treated in this study, SPG stimulation is an effective acute therapy in 45% of patients, offering sustained effectiveness over 24 months of observation. In addition, a maintained, clinically relevant reduction of attack frequency was observed in a third of patients. These long-term data provide support for the use of SPG stimulation for disabled patients and should be considered after medical treatments fail, are not tolerated or are inconvenient for the patients.

scholarly journals Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache

Cephalalgia ◽  
2015 ◽  
Vol 36 (6) ◽  
pp. 503-509 ◽  
Author(s):  
Daniel Fossum Bratbak ◽  
Ståle Nordgård ◽  
Lars Jacob Stovner ◽  
Mattias Linde ◽  
Mari Folvik ◽  
...  
Keyword(s):  
Pilot Study ◽  
Cluster Headache ◽  
Chronic Cluster Headache ◽  
Post Treatment ◽  
Attack Frequency ◽  
Open Label ◽  
Intention To Treat ◽  
Efficacy Outcome ◽  
Treat Analysis

Objective The main object of this pilot study was to investigate the safety of administering onabotulinumtoxinA (BTA) towards the sphenopalatine ganglion (SPG) in intractable chronic cluster headache. Efficacy data were also collected to provide indication on whether future placebo-controlled studies should be performed. Method In a prospective, open-label, uncontrolled study, we performed a single injection of 25 IU ( n = 5) or 50 IU BTA ( n = 5) towards the SPG in 10 patients with intractable chronic cluster headache with a follow-up of 24 weeks. The primary outcome was adverse events (AEs) and the main efficacy outcome was attack frequency in weeks 3 and 4 post-treatment. Results A total of 11 AEs were registered. There was one severe adverse event (SAE): posterior epistaxis. The number of cluster headache attacks (main efficacy outcome) was statistically significantly reduced in the intention-to-treat analysis from 18 ± 12 per week in baseline to 11 ± 14 ( p = 0.038) in weeks 3 and 4, and five out of 10 patients had at least 50% reduction of attack frequency compared to baseline. The cluster attack frequency was significantly reduced for five out of six months post-treatment. Conclusion Randomised, placebo-controlled studies are warranted to establish the potential of this possible novel treatment of cluster headache.

Cluster headache in children and adolescents: Ten years of follow-up in three pediatric cases

Cephalalgia ◽  
2011 ◽  
Vol 31 (13) ◽  
pp. 1409-1414 ◽  
Author(s):  
Marco A Arruda ◽  
Lucas Bonamico ◽  
Cleiber Stella ◽  
Carlos A Bordini ◽  
Marcelo E Bigal
Keyword(s):  
Case Report ◽  
Cluster Headache ◽  
Spontaneous Remission ◽  
Response To Therapy ◽  
Case Examples ◽  
The Third ◽  
First Case ◽  
Long Term Follow Up

Background: Cluster headache (CH) is a rare cause of headache in children. Onset before 12 years of age is unusual, and long-term follow-up of pediatric cases has been not reported. Objectives: To report three cases of CH with onset at childhood and at least ten years of follow-up. Methods: Case report. Results: The first case is that of a 12-year-old boy with episodic CH with unilateral pain and striking, bilateral autonomic manifestations, remitted for over eight years. The second case is unique in that it reports a case of chronic CH in a 13-year-old boy with Down syndrome. The third case is that of a 9-year-old girl with episodic CH with remissions of 2 and 5 years. All cases had prominent autonomic features. The frequency and duration of the attacks were similar to those that have been reported in adults. Good response to indomethacin was obtained in two cases, although tolerability issues occurred in one. Conclusion: Sustained, long-term, medical and/or spontaneous remission occurs in CH of early onset. The phenotype and response to therapy in children, at least in these case examples, are similar to equivalent observations in adult patients with CH.

Long-Term Efficacy of Occipital Nerve Stimulation for Medically Intractable Cluster Headache

Neurosurgery ◽  
2020 ◽  
Author(s):  
Aurélie Leplus ◽  
Denys Fontaine ◽  
Anne Donnet ◽  
Jean Regis ◽  
Christian Lucas ◽  
...  
Keyword(s):  
Cluster Headache ◽  
Nerve Stimulation ◽  
Occipital Nerve Stimulation ◽  
Attack Frequency ◽  
Occipital Nerve ◽  
Term Efficacy ◽  
Additional Surgery ◽  
Over Time

ABSTRACT BACKGROUND Occipital nerve stimulation (ONS) has been proposed to treat refractory chronic cluster headache (rCCH) but its efficacy has only been showed in small short-term series. OBJECTIVE To evaluate ONS long-term efficacy in rCCH. METHODS We studied 105 patients with rCCH, treated by ONS within a multicenter ONS prospective registry. Efficacy was evaluated by frequency, intensity of pain attacks, quality of life (QoL) EuroQol 5 dimensions (EQ5D), functional (Headache Impact Test-6, Migraine Disability Assessment) and emotional (Hospital Anxiety Depression Scale [HAD]) impacts, and medication consumption. RESULTS At last follow-up (mean 43.8 mo), attack frequency was reduced >50% in 69% of the patients. Mean weekly attack frequency decreased from 22.5 at baseline to 9.9 (P < .001) after ONS. Preventive and abortive medications were significantly decreased. Functional impact, anxiety, and QoL significantly improved after ONS. In excellent responders (59% of the patients), attack frequency decreased by 80% and QoL (EQ5D visual analog scale) dramatically improved from 37.8/100 to 73.2/100. When comparing baseline and 1-yr and last follow-up outcomes, efficacy was sustained over time. In multivariable analysis, low preoperative HAD-depression score was correlated to a higher risk of ONS failure. During the follow-up, 67 patients experienced at least one complication, 29 requiring an additional surgery: infection (6%), lead migration (12%) or fracture (4.5%), hardware dysfunction (8.2%), and local pain (20%). CONCLUSION Our results showed that long-term efficacy of ONS in CCH was maintained over time. In responders, ONS induced a major reduction of functional and emotional headache-related impacts and a dramatic improvement of QoL. These results obtained in real-life conditions support its use and dissemination in rCCH patients.

WP1-1 Sphenopalatine ganglion stimulation for chronic cluster headache

2019 ◽  
Vol 90 (3) ◽  
pp. e2.3-e2
Author(s):  
S Miller ◽  
S Lagrata ◽  
M Matharu ◽  
L Zrinzo
Keyword(s):  
Cluster Headache ◽  
Acute Effect ◽  
Chronic Cluster Headache ◽  
Headache Frequency ◽  
Sphenopalatine Ganglion ◽  
Open Label ◽  
Vidian Canal ◽  
The Uk ◽  
Fluoroscopy Guidance

ObjectivesTo assess outcome of sphenopalatine ganglion stimulation (SPGS) in chronic cluster headache (CCH) in a UK centre.DesignUncontrolled open-label single centre prospective study.SubjectsNine patients with medically refractory CCH.MethodsParticipants 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.ResultsMean 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.ConclusionsInitial data from the UK confirms the results from previous studies and compares well with the results of occipital nerve stimulation for CCH.

scholarly journals MO286DESIGN OF A PH1, MULTICENTER TRIAL TO INVESTIGATE THE SAFETY, TOLERABILITY, PK/PD OF BION-1301 IN HEALTHY VOLUNTEERS AND ADULTS WITH IGAN AND A MULTICENTER, OPEN-LABEL EXTENSION STUDY FOR IGAN PATIENTS WHO PARTICIPATED IN A PRIOR TRIAL OF BION-1301

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Jonathan Barratt ◽  
Angelique Mittan ◽  
Suzanne Roy ◽  
Cailin Sibley ◽  
Colleen Stromatt ◽  
...  
Keyword(s):  
Phase 1 ◽  
Primary Objective ◽  
Clinical Activity ◽  
Phase 2 ◽  
Short Term ◽  
Open Label ◽  
Open Label Extension ◽  
Term Data

Abstract Background and Aims IgA nephropathy (IgAN), the leading cause of primary glomerulonephritis, is an autoimmune disease with no approved treatments.1 Progression to end-stage-renal disease occurs in up to 45% of IgAN patients, requiring dialysis or kidney transplant to manage.2-4 A critical step in IgAN pathogenesis is the production of galactose-deficient IgA1 (Gd-IgA1) leading to the generation of anti-Gd-IgA autoantibodies and the formation of immune complexes that result in kidney inflammation and damage.5 A Proliferation-Inducing Ligand (APRIL), a soluble factor that regulates B cell differentiation, proliferation and survival of plasma cells, and IgA class-switching is elevated in patients with IgAN6, 7. IgAN patients with high plasma APRIL levels are reported as having higher levels of Gd-IgA1 and proteinuria and lower estimated glomerular filtration rates compared to those with lower plasma APRIL levels.7 BION-1301 is a novel humanized blocking antibody targeting APRIL. The primary objective of Study ADU-CL-19 is to assess the short-term safety and tolerability of BION-1301 in Healthy Volunteers (HV) and IgAN patients and to secondarily assess the short-term pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary clinical activity of BION-1301. The primary objective of Study ADU-CL-24 is to characterize the long-term safety of BION-1301 in IgAN patients who completed treatment in ADU-CL-19 while secondarily assessing the long-term PK, PD, immunogenicity, and preliminary clinical activity of BION-1301. Method The Phase 1 study (ADU-CL-19; NCT03945318) comprises 3 parts. Parts 1 and 2 are double-blind, randomized, placebo-controlled single and multiple ascending dose designs in HV; both parts have been completed. Part 3 is an ongoing multicenter (US and UK), multiple-dose, two cohort design in approximately 20 patients with IgAN (10/cohort). Key eligibility criteria for Part 3 includes: (1) urine protein ≥0.5 g/24h or baseline UPCR ≥0.5 g/g, (2) stable/optimized dose of ACE-I/ARB or intolerant to ACE-I/ARB, and (3) biopsy-verified diagnosis of IgAN within the past 10 years. In Part 3, patients in Cohort 1 are receiving BION-1301 at 450mg every 2 weeks for 3 months. The dose and schedule for Cohort 2 will be determined by the Safety Review Team (SRT) based on data from the first 5 patients. After 3 months of treatment, patients continue safety follow-up for approximately 6 months unless deciding to enroll in the open-label extension (OLE) study, withdraw from the study, or are lost to follow up. Study ADU-CL-24 (NCT04684745) is a Phase 2 Open-Label Extension (OLE) of Study ADU-CL-19. Eligibility for the OLE study is restricted to those patients who completed at least 75% of their intended doses as well as the End of Treatment (EOT) visit in Study ADU-CL-19. Patients who enroll directly from the ADU-CL-19 EOT visit are not required to attend an additional screening visit. This is encouraged to maintain un-interrupted dosing. Once enrolled in the OLE, patients receive BION-1301 at the same dose and regimen as assigned in the parent study for up to 2 years. The dose, route, and regimen of BION-1301 may change after review of emergent safety, PK, PD and efficacy data by the SRT. Results Parts 1 and 2 of the Phase 1 study in HV are complete and the data were presented at ASN in 20208 Part 3 of the Phase 1 and the Phase 2 OLE study are ongoing, and interim results from the first dose cohort in IgAN patients are being presented in a separate poster at this meeting. Conclusion The design of the Phase 1 and Phase 2 OLE studies described in HVs and IgAN patients have enabled the generation of short- and long-term safety, PK, PD, immunogenicity and preliminary efficacy data for BION-1301. The Phase 1 short-term data will guide the design of future later-stage trials of BION-1301, while the long-term data from OLE will enable a greater understanding of the potential long-term risk/benefit profile of BION-1301 in IgAN patients.

scholarly journals Rituximab-Containing Risk-Adapted Treatment Strategy in Nodular Lymphocyte Predominant Hodgkin Lymphoma: 7-Years Follow-Up

Cancers ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1760
Author(s):  
Novella Pugliese ◽  
Marco Picardi ◽  
Roberta Della Pepa ◽  
Claudia Giordano ◽  
Francesco Muriano ◽  
...  
Keyword(s):  
Side Effects ◽  
Hodgkin Lymphoma ◽  
Prognostic Score ◽  
Single Agent ◽  
Response To Therapy ◽  
Baseline Risk ◽  
Historical Cohort ◽  
Treatment Groups

Background: Nodular lymphocyte predominant Hodgkin lymphoma (NLPHL) is a rare variant of HL that accounts for 5% of all HL cases. The expression of CD20 on neoplastic lymphocytes provides a suitable target for novel treatments based on Rituximab. Due to its rarity, consolidated and widely accepted treatment guidelines are still lacking for this disease. Methods: Between 1 December 2007 and 28 February 2018, sixteen consecutive newly diagnosed adult patients with NLPHL received Rituximab (induction ± maintenance)-based therapy, according to the baseline risk of German Hodgkin Study Group prognostic score system. The treatment efficacy and safety of the Rituximab-group were compared to those of a historical cohort of 12 patients with NLPHL who received Doxorubicin, Bleomycin, Vinblastine, Dacarbazine (ABVD) chemotherapy followed by radiotherapy (RT), if needed, according to a similar baseline risk. The primary outcome was progression-free survival (PFS) and secondary outcomes were overall survival (OS) and side-effects (according to the Common Terminology Criteria for Adverse Events, v4.03). Results: After a 7-year follow-up (range, 1–11 years), PFS was 100% for patients treated with the Rituximab-containing regimen versus 66% for patients of the historical cohort (p = 0.036). Four patients in the latter group showed insufficient response to therapy. The PFS for early favorable and early unfavorable NLPHLs was similar between treatment groups, while a better PFS was recorded for advanced-stages treated with the Rituximab-containing regimen. The OS was similar for the two treatment groups. Short- and long-term side-effects were more frequently observed in the historical cohort. Grade ≥3 neutropenia was more frequent in the historical cohort compared with the Rituximab-group (58.3% vs. 18.7%, respectively; p = 0.03). Long-term non-hematological toxicities were observed more frequently in the historical cohort. Conclusion: Our results confirm the value of Rituximab in NLPHL therapy and show that Rituximab (single-agent) induction and maintenance in a limited-stage, or Rituximab with ABVD only in the presence of risk factors, give excellent results while sparing cytotoxic agent- and/or RT-related damage. Furthermore, Rituximab inclusion in advanced-stage therapeutic strategy seems to improve PFS compared to conventional chemo-radiotherapy.

Vidian Neurectomy for Management of Chronic Cluster Headache

Neurosurgery ◽  
2018 ◽  
Vol 84 (5) ◽  
pp. 1059-1064 ◽  
Author(s):  
Shao-Cheng Liu ◽  
Ming-Chang Kao ◽  
Yun-Chen Huang ◽  
Wan-Fu Su
Keyword(s):  
Cluster Headache ◽  
Chronic Cluster Headache ◽  
Preliminary Evaluation ◽  
Sphenopalatine Ganglion ◽  
Attack Frequency ◽  
Pain Disability Index ◽  
Pain Disability ◽  
Vidian Neurectomy ◽  
Headache Onset ◽  
Attack Intensity

Abstract BACKGROUND Management of chronic cluster headache (CCH) remains a challenging endeavor, and the optimal surgical approach for medically refractory CCH remains controversial. OBJECTIVE To conduct a preliminary evaluation of the efficacy and safety of vidian neurectomy (VN) in patients with medically refractory CCH. METHODS Between March 2013 and December 2015, 9 CCH patients, all of whom had failed to respond to conservative therapy, underwent VN with a precise nerve cut and maximal preservation of the sphenopalatine ganglion. Data included demographic variables, cluster headache onset and duration, mean attack frequency, mean attack intensity, and pain disability index measures pre- and through 12-mo postsurgery. RESULTS Seven of the 9 cases (77.8%) showed immediate improvement. Improvement was delayed by 1 mo in 1 patient, after which the surgical effects of pain relief were maintained throughout the follow-up period. One patient (11.1%) did not improve after surgery. One year after VN, patients’ mean attack frequency, mean attack intensity, and pain disability index decreased by 54.5%, 52.9%, and 56.4%, respectively. No patient experienced treatment-related side effects or complications. CONCLUSION VN is an effective treatment method for CCH patients. Precise Vidian nerve identification and maximal preservation of the sphenopalatine ganglion may achieve good surgical outcomes and dramatically improve quality of life among patients, without significant adverse events.

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