scholarly journals Effects of Botulinum Toxin on Migraine Attack Features in Chronic Migraine: A Six-Month Open-Label Observation Study through Electronic Diary Smartphone Application

Toxins ◽  
2019 ◽  
Vol 11 (11) ◽  
pp. 668 ◽  
Author(s):  
Antonio Santoro ◽  
Marianna Delussi ◽  
Maurizio Leone ◽  
Anna Maria Miscio ◽  
Laura De Rocco ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Central Sensitization ◽  
Smartphone Application ◽  
Electronic Diary ◽  
Open Label ◽  
Observation Study ◽  
Nociceptive Transmission ◽  
Headache Diary ◽  
Application Data

OnobotulintoxinA (OBT-A) is a treatment option for Chronic Migraine (CM). It works on central sensitization and pain but its mode of action is still unknown. To observe how OBT-A treatment works on single migraine attacks, this paper covers an over-6-month observation period through self-reported smartphone application data. This was an observational, open-label cohort study conducted on 34 CM patients under OBT-A treatment, selected between December 2016 and December 2017, who agreed to download a smartphone headache diary application (Aid Diary) according to the study instructions. The analysis was conducted using the smartphone application data reports on allodynia, intensity and extension of pain, and vegetative symptoms. We analysed a total of 707 records of single migraine attacks reported by compliant users (n = 34) in real-time. OBT-A significantly reduced allodynia, the number of vegetative symptoms, pain extension and intensity in single migraine attacks. Pain intensity was correlated with pain extension. In single migraine attacks, OBT-A improved symptoms of central sensitization. This action could be exerted by modulating nociceptive transmission and reducing the burden of single migraine episodes and improving the overall quality of life.

scholarly journals Occipital Nerve Stimulation for Refractory Chronic Migraine: Results of a Long-Term Prospective Study

2017 ◽  
Vol 1 (21;1) ◽  
pp. E151-E159 ◽  
Author(s):  
Dolores Rodrigo
Keyword(s):  
Surgical Technique ◽  
Chronic Migraine ◽  
Nerve Stimulation ◽  
Occipital Nerve Stimulation ◽  
Open Label ◽  
Occipital Nerve ◽  
Refractory Chronic Migraine

Background: Refractory chronic migraine affects approximately 4% of the population worldwide and results in severe pain, lifestyle limitations, and decreased quality of life. Occipital nerve stimulation (ONS) refers to the electric stimulation of the distal branches of greater and lesser occipital nerves; the surgical technique has previously been described and has demonstrated efficacy in the treatment of a wide variety of headache disorders. Objectives: The aim of this study is to evaluate the long-term efficacy and tolerability of ONS for medically intractable chronic migraine. Study Design: Prospective, long-term, open-label, uncontrolled observational study. Setting: Single public university hospital. Methods: Patients who met the International Headache Society criteria for chronic migraine, all of them having been previously treated with other therapeutic alternatives, and who met all inclusion and exclusion criteria for neurostimulation, received the implantation of an ONS system after a positive psychological evaluation and a positive response to a preliminary occipital nerve blockage. The implantation was performed in 2 phases: a 10 day trial with implanted occipital leads connected to an external stimulator and, if more than 50% pain relief was obtained, permanent pulse generator implantation and connection to the previously implanted leads. After the surgery, the patients were thoroughly evaluated annually using different scales: pain Visual Analogue Scale (VAS), number of migraine attacks per month, sleep quality, functionality in social and labor activities, reduction in pain medication, patient satisfaction, tolerability, and reasons for termination. The average follow-up time was 9.4 ± 6.1 years, and 31 patients completed a 7-year follow-up period. Results: Thirty-seven patients were enrolled and classified according to the location and quality of their pain, accompanying symptoms, work status, and psychological effects. Substantial pain reduction was obtained in most patients, and the VAS decreased by 4.9 ± 2.0 points. These results remained stable over the followup period. Five of the 35 permanently implanted patients with migraine attacks at baseline were free from these attacks at their last visits, whereas the pain severity decreased 3.8 ± 2.5 (according to the VAS) in the remaining patients. Seven of the 35 permanent implanted devices were definitively removed: 2 devices because of treatment inefficacy, and 5 devices because the patients were asymptomatic and considered to be cured from their pain, even with the stimulation off. Systemic side effects were not observed. Limitations: Limitations of the current study include its uncontrolled and open-label design. Additionally, not all patients completed the 7-year follow-up period. Conclusions: We consider that the trigemino-cervical autonomous and cervical connection may explain why ONS might relieve chronic migraine pain, but this is just a theoretical explanation which should be demonstrated in future studies. The results achieved in this study suggest that ONS may provide longterm benefits for patients with medically intractable chronic migraine. These outcomes are slightly better than previous reports and were maintained over the 7-year follow-up. We believe that an accurate selection of patients, realization of diagnostic occipital nerve blocks, psychological evaluations, rigorous surgical technique, and appropriate parameter programming helped us achieve these outcomes. Key words: Refractory chronic migraine, headache, occipital nerve stimulatino, peripheral nerve stimulation, occipital nerve block

The use of the monoclonal antibody Erenumab in patients with chronic migraine in real clinical experience

2021 ◽  
Vol 26 (5) ◽  
pp. 44-50
Author(s):  
E. V. Ekusheva ◽  
A. R. Artemenko ◽  
E. V. Shirshova ◽  
P. E. Sokov ◽  
A. M. Plieva
Keyword(s):  
Chronic Migraine ◽  
Subcutaneous Administration ◽  
Clinical Score ◽  
Preventive Therapy ◽  
Medical Monitoring ◽  
Open Label ◽  
Good Tolerance ◽  
Open Label Study ◽  
Rapid Relief

Patients with chronic migraine are characterized by frequent severe headache attacks, polypharmacy (painkillers), insufficient effect of preventive therapy, and a decrease in the quality of life. The aim of a prospective open-label study was the evaluation of the efficacy and tolerance of Erenumab (Irinex) in the treatment of patients with chronic migraine in real clinical practice.Material and methods. 48 patients with chronic migraine were clinically and neurologically examined (35.5 [19; 56]; diagnosis was established according to the criteria of ICHD classification and diagnosis of migraine. Medical monitoring period was 3 months. Clinical and neurological testing and subcutaneous administration of Erenumab (Irinex) 70 mg were performed once a month during the whole period.Results. Safety, good tolerance and an obvious significant clinical effect were noted when using Erenumab (Irinex) 70 mg. It led to a significant improvement in clinical score and the course of chronic migraine, the effectiveness of rapid relief of symptoms and significant reduction in the need for painkillers in most patients. The best results were found after 3 months of therapy.

scholarly journals OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine over one year of treatment: Pooled results from the PREEMPT randomized clinical trial program

Cephalalgia ◽  
2016 ◽  
Vol 36 (9) ◽  
pp. 899-908 ◽  
Author(s):  
Richard B Lipton ◽  
Noah L Rosen ◽  
Jessica Ailani ◽  
Ronald E DeGryse ◽  
Patrick J Gillard ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Migraine ◽  
Life Questionnaire ◽  
Open Label ◽  
Double Blind ◽  
Significant Difference ◽  
Related Quality ◽  
Prophylaxis Therapy ◽  
Clinical Trial Program

Background Chronic migraine (CM) is associated with high impact and reduced health-related quality of life (HRQoL). Methods Patients with CM from PREEMPT (Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy) were randomized (1:1) to receive onabotulinumtoxinA or placebo for two 12-week cycles in the double-blind (DB) phase, followed by three 12-week cycles of open-label (OL) onabotulinumtoxinA (onabotulinumtoxinA/onabotulinumtoxinA (O/O) and placebo/onabotulinumtoxinA (P/O) groups, respectively). HRQoL endpoints were assessed over 56 weeks using the Headache Impact Test (HIT-6) and the Migraine-Specific Quality of Life Questionnaire (MSQ). HIT-6 score reductions ≥2.3 and ≥5 denoted between-group minimally important difference and within-patient clinically meaningful response, respectively. Results A total of 1236 participants (O/O, n = 607; P/O, n = 629) participated in both phases. The DB phase showed significantly reduced HIT-6 and MSQ for onabotulinumtoxinA versus placebo (all p < 0.001). The OL phase showed significantly reduced HIT-6 for O/O versus P/O at weeks 28, 36, and 48, but not 56. All three MSQ domains showed improved HRQoL relative to baseline, but only the role restrictive domain showed a significant difference between O/O and P/O at week 56. Conclusions Benefits of onabotulinumtoxinA on HRQoL versus baseline persisted throughout the OL phase. Statistical superiority in favor of O/O was demonstrated for HIT-6 through 48 weeks and for MSQ (role restrictive) at 56 weeks.

Effects of Botulinum Toxin A on Allodynia in Chronic Migraine: An Observational Open-Label Two-Year Study

2019 ◽  
Vol 81 (1-2) ◽  
pp. 37-46 ◽  
Author(s):  
Marina de Tommaso ◽  
Filippo Brighina ◽  
Marianna Delussi
Keyword(s):  
Chronic Migraine ◽  
Central Sensitization ◽  
Botulinum Toxin A ◽  
Term Effect ◽  
Frequency Change ◽  
Headache Frequency ◽  
Open Label ◽  
Long Term Outcome ◽  
Long Term Effect

Background: Onabotulinumtoxin A (OBT-A) is a treatment option for chronic migraine (CM), though the possible effect on central sensitization and allodynia is still unknown. Aims: The present study aimed to evaluate (1) the long-term outcome of allodynia in a group of CM treated with OBT-A (2) if the presence and severity of allodynia could predict the long-term effect of OBT-A (3) if the improvement of allodynia, could contribute to the clinical efficacy of OBT-A. Methods: This was an observational, open-label, cohort study conducted on 99 CM patients treated for 1 year and 44 patients treated for 2 years with periodic OBT-A 155–195 U injections. In basal condition (T0), after 1 year (T1) and 2 years (T2) treatment, allodynia, migraine disability, and headache frequency were the main variables. Anxiety, depression and sleep deprivation were also considered potentially correlated factors to allodynia. Results: Allodynia decreased after 1 year (Student t test p = 0.0001), and decreased further after the second year of treatment (p = 0.015). There was a relationship between allodynia severity at T0 and reduced headache frequency change at T1 (r = 0.22) and T2 (r = 0.37). The effect of OBT-A on allodynia correlated with the reduction of MIDAS score after 1 year (r = 0.4) and 2 years (r = 0. 63) of treatment. Conclusions: OBT-A seems to have an effect on central sensitization, expressed by allodynia. This action could be exerted by modulating nociceptive transmission, and reducing the global burden of migraine. Patients with more severe allodynia display a limited long-term effect on headache frequency. The modulation of central sensitization could reduce migraine disability, in spite of the persistence of frequent headache.

Pilot, open non-controlled trial to assess the feasibility of implementing objective parameters as primary endpoints in a clinical trial with patients affected by knee osteoarthritis. (Preprint)

2019 ◽  
Author(s):  
Bogdan Corneliu Andor ◽  
Dionisio Franco Barattini ◽  
Dumitru Emanuel Dogaru ◽  
Simone Guadagna ◽  
Serban Rosu
Keyword(s):  
Chondroitin Sulphate ◽  
Controlled Trial ◽  
Subjective Evaluation ◽  
Pilot Trial ◽  
Final Visit ◽  
Life Questionnaire ◽  
Quality Of Data ◽  
Open Label ◽  
Objective Measurements

BACKGROUND Osteoarthritis (OA) is one of the top five most disabling conditions and it affects more than one third of persons over 65 years of age. Currently 80% of persons affected by OA already report having some movement limitation, 20% of people are not be able to perform major activities of daily living, and about 11% of the total affected population need of personal care. On 2014 the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) suggested as first step of pharmacological treatment for knee OA a background therapy with chronic symptomatic slow-acting drugs for osteoarthritis (SYSADOAs), such as glucosamine sulphate, chondroitin sulphate and hyaluronic acid (HA). In studies with oral HA, symptoms of OA are often measured using subjective parameters such as the visual analog scale (VAS) or the quality of life questionnaire (QoL) and objective measurements as ultrasonography (US) or range of motion (ROM) are employed in very few trials. This affects the quality of data in the literature. OBJECTIVE The primary objective of this work is to assess the feasibility of implementing US and ROM as objective measurements to correlate the improvement of knee mobility with pain reduction, evaluated using a subjective scale (VAS) in patients assuming a nutraceutical containing HA. The secondary objective is to evaluate the enrollment rate in one month to verify the feasibility for time and budget of the planned future main study. The explorative objective of the trial is to obtain preliminary data on efficacy of the tested product. METHODS This open-label pilot trial is performed in an orthopedic clinic (Timisoara, Romania). Male and female subjects (from 50 to 70 years) diagnosed with symptomatic OA of the knee with mild joint discomfort for at least 6 months are included. Following protocol, 8 patients are administered for 8 weeks Syalox® 300 Plus (River Pharma, Italy), a product based on HA of high molecular weight. Baseline and final visit assessments include orthopedic assessment, US, Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire, VAS and ROM of knee. RESULTS Data collection occurred between February 2018 and June 2018. All results are expected to be available by the end of 2018. CONCLUSIONS This pilot trial will be the first study to analyze the potential correlation between subjective evaluation (VAS, KOOS questionnaire) and objective measurements (US, ROM and actigraphy). The data from this study will assess the feasibility of the planned monthly recruitment rate and the necessary time and budget, and should provide preliminary information on efficacy of the tested product. CLINICALTRIAL ClinicalTrials.gov (NCT number: NCT03421054).

scholarly journals ECOCAPTURE@HOME: Protocol for the Remote Assessment of Apathy and Its Everyday-Life Consequences

2021 ◽  
Vol 18 (15) ◽  
pp. 7824
Author(s):  
Valérie Godefroy ◽  
Richard Levy ◽  
Arabella Bouzigues ◽  
Armelle Rametti-Lacroux ◽  
Raffaella Migliaccio ◽  
...  
Keyword(s):  
Everyday Life ◽  
New Technologies ◽  
Electrodermal Activity ◽  
Real Life ◽  
Smartphone Application ◽  
Measurement Model ◽  
Strong Impact ◽  
Active Data ◽  
Personalised Treatment

Apathy, a common neuropsychiatric symptom associated with dementia, has a strong impact on patients’ and caregivers’ quality of life. However, it is still poorly understood and hard to define. The main objective of the ECOCAPTURE programme is to define a behavioural signature of apathy using an ecological approach. Within this program, ECOCAPTURE@HOME is an observational study which aims to validate a method based on new technologies for the remote monitoring of apathy in real life. For this study, we plan to recruit 60 couples: 20 patient-caregiver dyads in which patients suffer from behavioral variant Fronto-Temporal Dementia, 20 patient-caregiver dyads in which patients suffer from Alzheimer Disease and 20 healthy control couples. These dyads will be followed for 28 consecutive days via multi-sensor bracelets collecting passive data (acceleration, electrodermal activity, blood volume pulse). Active data will also be collected by questionnaires on a smartphone application. Using a pool of metrics extracted from these passive and active data, we will validate a measurement model for three behavioural markers of apathy (i.e., daytime activity, quality of sleep, and emotional arousal). The final purpose is to facilitate the follow-up and precise diagnosis of apathy, towards a personalised treatment of this condition within everyday life.

scholarly journals Efficacy and safety of fremanezumab in patients with episodic and chronic migraine with documented inadequate response to 2 to 4 classes of migraine preventive medications over 6 months of treatment in the phase 3b FOCUS study

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Messoud Ashina ◽  
Joshua M. Cohen ◽  
Maja Galic ◽  
Verena Ramirez Campos ◽  
Steve Barash ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Medication Use ◽  
Episodic Migraine ◽  
Inadequate Response ◽  
Open Label ◽  
Double Blind ◽  
Moderate Severity ◽  
Preventive Medication ◽  
Open Label Extension ◽  
Acute Headache

Abstract Background Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) selectively targets the calcitonin gene-related peptide and has proven efficacy for the preventive treatment of migraine. In this study, we evaluated the long-term efficacy, safety, and tolerability of monthly and quarterly fremanezumab. Methods Episodic migraine and chronic migraine patients completing the 12-week double-blind period of the FOCUS trial entered the 12-week open-label extension and received 3 monthly doses of fremanezumab (225 mg). Changes from baseline in monthly migraine days, monthly headache days of at least moderate severity, days of acute headache medication use, days with photophobia/phonophobia, days with nausea or vomiting, disability scores, and proportion of patients achieving a ≥50% or  ≥75% reduction in monthly migraine days were evaluated. Results Of the 807 patients who completed the 12-week double-blind treatment period and entered the open-label extension, 772 patients completed the study. In the placebo, quarterly fremanezumab, and monthly fremanezumab dosing regimens, respectively, patients had fewer average monthly migraine days (mean [standard deviation] change from baseline: − 4.7 [5.4]; − 5.1 [4.7]; − 5.5 [5.0]), monthly headache days of at least moderate severity (− 4.5 [5.0]; − 4.8 [4.5]; − 5.2 [4.9]), days per month of acute headache medication use (− 4.3 [5.2]; − 4.9 [4.6]; − 4.8 [4.9]), days with photophobia/phonophobia (− 3.1 [5.3]; − 3.4 [5.3]; − 4.0 [5.2]), and days with nausea or vomiting (− 2.3 [4.6]; − 3.1 [4.5]; − 3.0 [4.4]). During the 12-week open-label extension, 38%, 45%, and 46% of patients, respectively, achieved a ≥50% reduction and 16%, 15%, and 20%, respectively, achieved a ≥75% reduction in monthly migraine days. Disability scores were substantially improved in all 3 treatment groups. There were low rates of adverse events leading to discontinuation (<1%). Conclusion Fremanezumab demonstrated sustained efficacy up to 6 months and was well tolerated in patients with episodic migraine or chronic migraine and documented inadequate response to multiple migraine preventive medication classes. Trial registration ClinicalTrials.gov NCT03308968 (FOCUS).

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