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Chronic Migraine clinical trials

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NCT ID: NCT05754190 Recruiting - Chronic Pain Clinical Trials

Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA

Start date: June 20, 2023
Phase:
Study type: Observational

This study relies on the use of a smartphone application (SOMA) that the investigators developed for tracking daily mood, pain, and activity status in acute pain, chronic pain, and healthy controls over four months.The primary goal of the study is to use fluctuations in daily self-reported symptoms to identify computational predictors of acute-chronic pain transition, pain recovery, and/or chronic pain maintenance or flareups. The general study will include anyone with current acute or chronic pain, while a smaller sub-study will use a subset of patients from the chronic pain group who have been diagnosed with chronic low back pain, failed back surgery syndrome, or fibromyalgia. These sub-study participants will first take part in one in-person EEG testing session while completing simple interoception and reinforcement learning tasks and then begin daily use of the SOMA app. Electrophysiologic and behavioral data from the EEG testing session will be used to determine predictors of treatment response in the sub-study.

NCT ID: NCT05730556 Recruiting - Chronic Migraine Clinical Trials

A Study of Remote Electrical Neuromodulation for Acute Procedural Pain

Start date: February 13, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effectiveness of using remote electrical neuromodulation, using the Nerivio ® device, to relieve pain associated with receiving onabotulinumtoxinA (Botox) injections for chronic migraine prevention.

NCT ID: NCT05720819 Completed - Virtual Reality Clinical Trials

Biofeedback-VR for Treatment of Chronic Migraine

Start date: September 9, 2020
Phase: N/A
Study type: Interventional

Migraine is a common, debilitating neurologic condition affecting more than 900 million individuals worldwide. Established treatments for migraine include medications, vitamin and herbal supplements, neuromodulation, and behavioral treatment strategies. This study aims to determine whether a novel, home-based behavioral approach, combined biofeedback-virtual reality therapy, can improve self-reported migraine-related outcomes in individuals living with chronic migraine. In this randomized, controlled pilot study, 50 adults with chronic migraine are randomized to the experimental group (frequent use of a heart rate variability biofeedback-virtual reality device plus standard medical care; n=25) or wait-list control group (standard medical care alone; n=25). The primary outcome is reduction in mean monthly headache days between groups at 12 weeks. Secondary outcomes include mean change in acute analgesic use frequency, depression, migraine-related disability, stress, insomnia, and catastrophizing between groups at 12 weeks. Tertiary outcomes include change in heart rate variability and device-related user experience measures.

NCT ID: NCT05679908 Completed - Chronic Migraine Clinical Trials

A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine

PREVENTION
Start date: December 6, 2022
Phase: Phase 2
Study type: Interventional

This is a phase 2, double-blind, randomized, multicenter, placebo-controlled, three arm parallel study to evaluate the efficacy and safety of two different dosages (30 IU daily and 60 IU daily) of TNX-1900 in patients with chronic migraine.

NCT ID: NCT05679765 Completed - Headache Clinical Trials

Efficacy of GONB in Patients of Migraine

Start date: April 1, 2022
Phase: Phase 4
Study type: Interventional

The study was carried to determine the analgesic efficacy of greater occipital nerve block in patients of migraine. It was a randomised controlled which took place from april 2022 - october 2022. Fifty patients suffering from migraine were included in the study. Patients in Group G were given greater occipital nerve block (GONB) with lignocaine and dexamethasone under ultrasound guidance while those in Group S were given saline 0.9% as placebo. Pain score using Numeric Rating Scale and number of headache days was assessed at four,eight and twelve weeks after the procedure as a primary outcome. Total headache days were recorded as a secondary outcome.

NCT ID: NCT05598723 Recruiting - Chronic Migraine Clinical Trials

BOTOX® vs. XEOMIN® for Chronic Migraine

Start date: February 24, 2023
Phase: Phase 3
Study type: Interventional

Chronic migraine (CM) is a disabling disorder that sidelines active duty personnel and diminishes their quality of life. It affects 1.3% to 2.4% of the general population. These numbers increase in active duty personnel, especially those returning from deployment, as well as in veterans. Furthermore, these numbers are 4-5 times higher in military members who experienced at least one mild traumatic brain injury. CM leads to impaired cognition and poor decision-making. These impairments on critical active duty tasks could have a significant impact on task readiness and military performance. Therefore, CM presents a challenge for the "return to duty" mission. Currently, onabotulinumtoxinA is the only FDA-approved prophylactic treatment for CM; however, this treatment requires refrigeration, to which there is little access for the forward-deployed members who have limited access to adequate storage for this treatment. Therefore, it is imperative to identify a CM treatment that does not require refrigeration. Furthermore, in light of the ongoing COVID-19 pandemic and resulting international shortages in critical medication production and delivery, it is imperative to identify more than one treatment option for the management of CM. In this study, we will test the efficacy of incobotulinumtoxinA, a neurotoxin that, unlike onabotulinumtoxinA, does not require refrigeration, but is an effective off-label alternative for the treatment of migraine. OnabotulinumtoxinA and incobotulinumtoxinA are comparable in strength, with a conversion ratio of 1:1.

NCT ID: NCT05568004 Completed - Migraine Clinical Trials

The Effect of Exercise on Migraine Attacks in Chronic Migraine

Start date: November 28, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effect of different exercise types and combinations on migraine attacks in patients with chronic migraine.

NCT ID: NCT05536050 Recruiting - Fibromyalgia Clinical Trials

Study of Low-dose Naltrexone in Chronic Migraine With Fibromyalgia

Start date: July 28, 2022
Phase:
Study type: Observational

This research aims to look at the effect of low-dose naltrexone on the severity and frequency of attacks in people with chronic migraine with or without new daily persistent headache and fibromyalgia. A few studies suggest low-dose naltrexone is effective for fibromyalgia, but it has not been studied in patients with migraine and headaches. Our goal is to see if there is an improvement in either severity and frequency of attacks and overall impact on quality of life over a three-month period.

NCT ID: NCT05517200 Recruiting - Migraine Clinical Trials

Pilot Study for a Machine Learning Test for Migraine

MLTM
Start date: September 3, 2022
Phase:
Study type: Observational [Patient Registry]

This study is a single center, random participant selection, data analyst is blinded to patient identifiers, controlled clinical trial. The proposed study is intended to establish safety and efficacy of quantifiable electrical biomarkers for migraine that can be used to confirm a diagnosis in people that have already been screened as positive for migraine using the gold standard participative criteria set out in the International Classification of Headache disorders-3 (ICHD-3) criteria. It is hypothesized that specific brain signals can be used to distinguish between migraine patients with and without aura from normal control and tension- type headache control participants by EEG enhanced with machine learning software.

NCT ID: NCT05415020 Recruiting - Migraine Clinical Trials

Determining the Utility of a Behavioral Intervention in Chronic Migraine

RLB
Start date: June 29, 2022
Phase: N/A
Study type: Interventional

This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. Additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. Successful completion of this proposal will inform the design of a future full-scale behavioral clinical trial to control chronic migraine.