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Migraine Disorders clinical trials

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NCT ID: NCT05596058 Terminated - Migraine Clinical Trials

Non-pharmacological Treatments in Migraine.

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Migraine may have an adverse effect on physical, cognitive, and psychosocial functioning. It causes major consequences for the quality of life of the sufferer and a major burden on the health care system. About the physiopathology, two opposing processes, depression (habituation) and facilitation (sensitization), determine the final behavioural outcome after a sequence of repetitive stimuli. Sensitization is a general behavioural response of augmentation to innocuous sensory and noxious stimuli. It has been associated with a dysfunction in descending pain inhibition. The nature or intensity of a painful event does not strongly relate to the development of chronic pain, but an individual's behavioural response to the event contributes to chronicity. Imaging data have identified that chronic pain may change the structure of the brain in response to environmental demands. It suggests that the brain of healthy control has a "healthy response" to frequent nociceptive input, such as "habituation", while chronic pain patients show a "maladaptive plasticity". Habituation is "a response decrement as a result of repeated stimulation". It is a phenomenon observed in the autonomic and behavioural component called the "orienting response" in humans. The orienting response is elicited when a novel stimulus is encountered, and it directs attention toward that stimulus. When the same stimulus is presented repeatedly occur habituation. Researchers have found a number of physiological mechanisms associated with Orienting response. Habituation of the orienting response is a simple form of learning and acts an attentional filtering mechanism that makes people able to select what is part of their present goal and adapt to environment. In this way only one channel of information to be processed, with the rest filtered out. Habituation depends on a memory process whereby the organism learns to associate goal irrelevant stimuli with a no-consequence response. Lack of Habituation during stimulus repetition is a functional property of the brain in people with migraine between attacks. Thalamo-cortical dysrhythmia and lack of H characterize migraineurs' brains. This abnormal information processing increases during the pain-free days, the vertex is just before the attack, and decreases in the ictal phase. Migraineurs are characterized by a generally increased sensitivity to visual (sensitivity to light), auditory (to sound), or somatic stimuli not only during the attack, but also outside of the attack. It was confirmed also by analysing motor cortex excitability. Aerobic exercises may be effective as pharmacological treatment in the management of migraine and focused attention task may help human subjects to better ignore irrelevant stimuli. The main aim of this study is to assess the efficacy of a non-pharmacological treatment, such as physical therapy, with a specific dual task protocol of active exercise with concomitant cognitive tasks, in relation to habituation (Transcranial magnetic stimulation) and sensitization (Algometer assessment) neurophysiological outcomes. The second aim is to assess these non-pharmacological treatments concerning to clinical outcomes (intensity of pain, duration of attacks and frequency of pain; neurophysiological test on executive functions).

NCT ID: NCT05284019 Terminated - Migraine Clinical Trials

Real World Effectiveness of Eptinezumab in Participants With Migraine

EVEC
Start date: March 4, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to examine how eptinezumab compares to other advanced preventive medications in a real-world community setting in adult participants with episodic migraine (EM) or chronic migraine (CM). These objectives include exploring the comparative effectiveness on patient reported outcomes.

NCT ID: NCT04936061 Terminated - Migraine Clinical Trials

Transnasal Cooling for Migraine

Start date: October 14, 2021
Phase: N/A
Study type: Interventional

This is a prospective, double-blind, sham-controlled, randomized study to assess the safety, tolerability, and optimal dose of the COOLSTAT Transnasal Thermal Regulating Device for acute treatment of migraine. The hypothesis is that evaporative cooling induced by the CoolStat using only ambient, dry air will reduce the pain and other symptoms of migraine headaches during an acute migraine episode.

NCT ID: NCT04520425 Terminated - Clinical trials for Chronic Migraine, Headache

Osteopathic Manipulative Techniques for the Treatment of Chronic Migraine Headaches

SMART-CM
Start date: September 8, 2022
Phase: N/A
Study type: Interventional

This study evaluates a standardized osteopathic manipulative therapy (OMT) as a treatment for chronic migraine headaches. It will determine the feasibility of enrolling patients in standardized osteopathic manipulative therapy trials, the acceptability of this specific treatment to patients, and evaluate its preliminary effectiveness.

NCT ID: NCT04349176 Terminated - Clinical trials for Chronic Migraine, Headache

Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?

Start date: May 12, 2017
Phase: Phase 3
Study type: Interventional

The study will enroll patients through the Neurology Department at Naval Medical Center San Diego (NMCSD). Eligible participants will meet criteria for chronic migraine, but will not be excluded based on the presence of significant comorbidities. Participants with comorbidities and medication regimens commonly exhibited within real-world DOD medical settings will not be excluded, such as pain disorders, psychiatric illness, medication overuse, and those who have used prophylactic medication during the baseline period. This will comprise "Group A". A carefully screened group will comprise "Group B" and meet exclusion criteria designed to approximate that of the PREEMPT2 trial. Within each group, half of the patients (155U Arm) will be randomly selected to receive the standard 155U over 31 fixed sites every 12 weeks while the other half (100U Arm) will receive 100U over 19 fixed sites every 12 weeks. Minimum sample size for the entire cohort is 132 participants (maximum n = 180), with a minimum of 66 participants per comparison.

NCT ID: NCT04106505 Terminated - Migraine Disorders Clinical Trials

Efficacy of a Novel App-based Migraine Treatment Platform - a Pilot Study

Start date: January 11, 2019
Phase: N/A
Study type: Interventional

This study evaluates biofeedback delivered through a smartphone as a treatment for migraine in adolescents. Three out of four participants will receive treatment as smartphone delivered biofeedback training, and one out of four participants will receive treatment as a sham-biofeedback app.

NCT ID: NCT04089761 Terminated - Acute Migraine Clinical Trials

Safety and Efficacy of Nerivio™ for the Acute Treatment of Migraine in Adolescents

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. This is a prospective, single arm, open label, multicenter trial of the safety and efficacy of Nerivio™ for the acute treatment of migraine in adolescents The study will be conducted in three phases: Phase I - Run-in: Phase II - Treatment phase: Phase III (optional) - Free-use

NCT ID: NCT03919045 Terminated - Chronic Migraine Clinical Trials

Saline Injections for Prophylactic Treatment of Chronic Migraine

Start date: June 17, 2019
Phase: Phase 4
Study type: Interventional

In this study, the investigators want to investigate whether saline injections in the neck and head muscles can reduce symptoms of chronic migraine. In existing studies, saline injections (used as placebo treatment) have given patients with chronic migraine an average of 7 headache-free days per month.

NCT ID: NCT03912337 Terminated - Migraine Clinical Trials

Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine

Start date: December 4, 2019
Phase: Phase 4
Study type: Interventional

To evaluate the effect of erenumab compared to placebo on disability in employed subjects with episodic migraine (EM) who have previously failed 1 or more migraine preventive treatments.

NCT ID: NCT03885154 Terminated - Clinical trials for Migraine in Children

Valproic Acid and Dihydroergotamine as Abortive Therapy in Pediatric Migraine

Start date: October 3, 2017
Phase: Phase 2
Study type: Interventional

The objective of this study is to compare clinical efficacy and tolerability of valproic acid (VPA) therapy versus dihydroergotamine (DHE) as abortive therapy in pediatric migraine.