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Chronic Migraine clinical trials

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NCT ID: NCT01833130 Completed - Chronic Migraine Clinical Trials

Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)

Start date: April 2013
Phase: Phase 4
Study type: Interventional

This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA (BOTOX®) in adults with chronic migraine.

NCT ID: NCT01813591 Completed - Chronic Migraine Clinical Trials

A Two-Arm Study Evaluation H.P. Acthar Injection Gel in Treatment of Chronic Migraines

Start date: April 2013
Phase: Phase 2
Study type: Interventional

This small study is to investigate the efficacy of Acthar in the treatment of chronic migraine in patients who have failed multiple treatments, including Botox (which is defined as having <30% reduction from baseline in the number of headache days per month). Despite the widespread use of anti-seizure medications, there remain a significant number of patient whose migraines are refractory to these agents. The pathophysiology of migraine is such that the neural substances calcitonin G related protein (CGRP), substance P, and neurokinin A are released at the trigeminal nerve endings innervating the large cranial and dura mater blood vessels and this neurotrasmission generates migraine associated pain. Because of this, treatment for migraine can be directed towards down regulating those receptor sites accordingly. Acthar may provide pain relief through this mechanist, as ACTH has been shown to inhibit the release of CGRP and may also provide relief through a negative feedback loop as exogenous ACTH inhibits CRH release and mast cell degranulation.

NCT ID: NCT01804517 Completed - Chronic Migraine Clinical Trials

Impact of a Nurse for Migraine Management: the IMPACT Project

IMPACT
Start date: February 2013
Phase: N/A
Study type: Observational [Patient Registry]

Headache disorders are prevalent, disabling, under recognized, under diagnosed and under treated. Migraine has a prevalence of 10% in men and 25% in women in Canada. The treatment of migraine is based on patient education (lifestyle habit modification, trigger avoidance), and pharmacological acute treatment and prophylaxis. A multidisciplinary approach allows a repartition of tasks between different health professionals. In a 2010 meeting, the Canadian Headache Society members supported the concept of Headache Centers, and a headache nurse was judged as an essential component of such centers. Gaul has reviewed the structured multidisciplinary approach that could be used in a headache centre and the existing studies using such structures. Five studies did include a headache nurse. No study did observe the impact of a nurse only. Resources in medical care are limited. One study did use a program of 96 hours, which does not seem realistic on the long-term and for a large pool of patients in a public hospital. Patients are not always able to pay for paramedical help such as physiotherapy and psychotherapy. Even if they do, finding a specialized therapist for chronic headache is difficult. Defining the role of a nurse and demonstrating the impact on patient care is therefore a first step in the concept of a headache center. Possible roles of a headache nurse according to Gaul are patient education, follow-up of the treatment plan, addressing patient queries, and monitoring of patient progress. The headache nurse may also participate in research projects. In a hospital Headache Clinic, the nurse may be involved in intra-venous treatments and blood sampling for research. In summary, evidence to demonstrate the impact of a nurse in a headache clinic is lacking. We propose to study this aspect prospectively. A study with positive findings would encourage health ministers to fund and support headache nurses for headache centers across Canada for headache management. Chronic headache and therefore chronic migraine would be a focus of such centers, since most patients seen in specialized centers are chronic. HYPOTHESIS: The addition of a headache nurse to the headache team will help the CHUM Migraine Clinic to improve treatment outcome, and reduce the burden of headache. This multidisciplinary approach will also allow a higher efficiency of the team.

NCT ID: NCT01741246 Completed - Migraine Clinical Trials

Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging

Start date: September 2011
Phase: N/A
Study type: Observational

Investigators hypothesize that chronic primary headaches are accompanied by a discrete pattern of brain metabolism and activity involving brain structures related to the development of acute exacerbations as well as pain modulation. Such structures include the brainstem, hypothalamus, and orbitofrontal cortex and can be defined using functional brain imaging.

NCT ID: NCT01720862 Completed - Chronic Migraine Clinical Trials

Migraine and Body Composition

Start date: April 2012
Phase: N/A
Study type: Observational

This research is being done to look at the association between migraine and obesity.

NCT ID: NCT01709708 Completed - Chronic Migraine Clinical Trials

Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine

Tx360
Start date: September 2012
Phase: Phase 4
Study type: Interventional

Migraine imposes a substantial burden on patients in terms of diminished daily functioning, quality of life, and financial loss. Pain severity and duration correlates with reduced measures of daily functioning, and overall health status. The sphenopalatine ganglion (SPG) has been implicated in a variety of cephalalgias. This has been well represented in the literature dating back over a century. Access to this structure can be gained via a small area of mucosa just posterior and superior to the tail of the middle turbinate on the lateral nasal wall. At this aspect, there is no bony boundary to the SPG. Blocking the SPG using local anesthetics relieves pain. Unfortunately, many current interventions are cumbersome, invasive, and expensive. The purpose of this study is to evaluate the efficacy of the Tx360™, a new nasal applicator device, in the treatment of head and face pain and to examine the economic implications. The Tx360™ is a single use device designed to deliver a topical local anesthetic to the specific area of mucosa associated with the SPG. A total of 42 study participants will be accepted into this double-blind placebo-controlled study. 28 will receive SPG blocks using a 0.3 mL of a 0.5% solution of Marcaine delivered by the Tx360™ while 14 will receive a placebo of saline substituted for the Marcaine. Both patient sets will also be given a piece of lemon hard candy as a taste distractor. Participants must have a chronic migraine history with over 15 symptomatic days per month over the past three months. The treatment plan consists of six weeks of treatment, two times per week. Short and longer term assessments will be retrieved and analyzed as detailed in the Study Design.

NCT ID: NCT01700387 Completed - Chronic Migraine Clinical Trials

A Study to Evaluate the Tolerability of Botox and Topiramate or Botox and Placebo and Effect on Cognitive Efficiency

Start date: October 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate sustained tolerability, quality of life, and change in cognitive efficiency following treatment with OnabotulinumtoxinA and daily topiramate vs. OnabotulinumtoxinA and daily placebo (Group A vs. Group B).

NCT ID: NCT01687088 Completed - Chronic Migraine Clinical Trials

Smell Sensitivity in Chronic Migraine: A Case-Control Study

Start date: July 2011
Phase: N/A
Study type: Observational

Olfactory impairment is a common symptom of neurologic disorders and may be related to dopaminergic dysfunction. Studies show that patients with migraine show increased sensitivity to light and sound. In our previous study in episodic migraineurs, olfaction was similar to age and sex-matched controls outside of attacks, but lower during acute attacks. The hypothesis is that olfactory function in chronic migraine (CM) will have mild impairment of olfaction at baseline but a more significant impairment during migraine or headache exacerbations. The investigators have two objectives: - To determine baseline olfactory acuity in subjects with CM and compare them to age and sex-matched controls - To determine how olfaction changes during acute exacerbations of migraine in those with CM To execute this study, the investigators will interview subjects and controls to ensure that they meet inclusion and exclusion criteria. After obtaining informed consent, subjects and controls will complete a questionnaire survey regarding their history or lack of history of headaches, smell sensitivity, osmophobia and current medication use and answer questions about attack frequency, location of headache, duration of disease, use of medication for pain, and disability. Both migraineurs and controls will take the University of Pennsylvania Smell Identification Test (UPSIT) in the office. After the first visit, migraineurs and controls will self-administer the UPSIT at home. They will be required to return the second test to the Jefferson Headache Center. The investigators will use analysis of variance (ANOVA) to determine variance in UPSIT scores between subjects and controls. To achieve a 90% power that the study will detect a statistically significant difference between the mean UPSIT scores at a two-sided 5 percent significance level, our sample size for both subjects and controls is 50.

NCT ID: NCT01667250 Completed - Chronic Migraine Clinical Trials

Non-Invasive Neurostimulation for the Prevention of Chronic Migraine

Start date: October 2012
Phase: N/A
Study type: Interventional

The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled pilot study is to study feasibility and collect preliminary clinical data related to the safety and clinical benefits of daily use of non-invasive vagal nerve stimulation with the GammaCore device for the prevention of chronic migraine, and to support the development and approval of a larger pivotal study.

NCT ID: NCT01496950 Completed - Chronic Migraine Clinical Trials

Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine

TMS-CHROMIG
Start date: October 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex is safe and effective for preventive treatment of chronic migraine, compared to placebo repetitive transcranial magnetic stimulation.