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Headache clinical trials

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NCT ID: NCT06245967 Not yet recruiting - Dizziness Clinical Trials

Frequency Specific Microcurrent Therapy for Mild Traumatic Brain Injury

Start date: February 15, 2024
Phase: N/A
Study type: Interventional

Patients with mild traumatic brain injury (mTBI) may experience spontaneous recovery within 7-10 days, but some continue to exhibit symptoms such as headache, dizziness, vertigo, poor concentration, and cognitive dysfunction. Effective treatments for these symptoms are currently lacking. Frequency Specific Microcurrent(FSM) has received approval from the U.S. FDA for use in neuroinflammatory conditions. Our study aims to evaluate the efficacy of FSM by using FSM device ,IS02LCDs Stimulator (Ru Yi Health ltd. Co,Taiwan R.O.C), on symptom improvement in 52 patients with mild TBI

NCT ID: NCT06225817 Not yet recruiting - Chronic Pain Clinical Trials

Placebo Impacts Sleep and Pain Modulation in Chronic Headache

Start date: April 28, 2024
Phase: N/A
Study type: Interventional

The goal of this free-choice parallel design clinical trial is to examine the potential beneficial effects of using open-label placebo (OLP) in improving chronic headache related outcomes and sleep quality. This study will enroll a cohort of participants with chronic headache which lasts for more than 3 months. The main questions it aims to answer are: 1. Will participants with chronic headache be more likely to take open-label placebo pills if they are introduced to the effects of placebo? 2. Will taking open-label placebo improve chronic pain related outcomes, such as chronic pain intensity, interference, levels of anxiety and depression, in the cohort of chronic headache? 3. Will open-label placebo improve sleep quality in participants suffering from chronic headache? To answer the above questions, participants with chronic headache will be randomly assigned to two groups: 1. Open-label placebo group where participants will be asked to take open-label placebo pills, one pill per day, for a total of 45 days. 2) wait-list group where participants will maintain their usual care without introducing open-label placebo to them during the 45 days monitoring. Researchers will compare the chronic pain intensity, interference, mood, anxiety, and sleep quality between the open-label placebo group and the wait-list group. Daily chronic pain will be measured using visual analog scale (VAS) ranging from 0=no pain at all to 100=maximum tolerable pain. Chronic pain interference using Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference and pain behavior. Anxiety and depression will be measured using PROMIS-anxiety, and PROMIS-depression scales respectively. Finally, sleep quality will be quantified using the objective measurement Motion Watch during the 45 days intervention and monitoring. In order to have a rigorous measurement of the baseline pain and sleep fluctuation, this study will include a 7-day phenotyping period before the starting of the 45-day intervention and monitoring. During the 7-day phenotyping period, participants will record their daily chronic pain and sleep quality using polysomnography.

NCT ID: NCT06206772 Recruiting - Cluster Headache Clinical Trials

Resting State Functional Connectivity in Cluster Headache

Start date: November 1, 2021
Phase:
Study type: Observational

Cluster headache is a highly disabling primary headache disorder, characterized by severe, excruciating, recurrent unilateral headache attacks. Typically, attacks' onset displays a circadian rhythm, and bout recurrence happens in a circannual fashion. Notably, the mechanisms underlying the shift between the remission phase and cluster bout are poorly understood. Thus, the investigators aim to study brain connectivity in episodic cluster headache patients. Additionally, an explorative analysis of functional connectivity in chronic cluster headache patients will be performed.

NCT ID: NCT06203873 Not yet recruiting - Migraine Clinical Trials

A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

BioMetal
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Migraine is one of the most common chronic neurological disorders, posing a significant global public health concern. Patent Foramen Ovale (PFO) is the most common congenital heart anomaly in adults. Mechanisms linking PFO to migraine include cortical spreading depression, vascular active substance theory, impaired cerebral autoregulation, and genetic susceptibility. Understanding these mechanisms holds promise for overcoming challenges in the prevention and treatment of migraines in PFO patients. At least 11 observational studies, comprising 1,632 subjects, described the efficacy of PFO closure in cryptogenic stroke. Of these, 34% had migraines, and percutaneous PFO closure reportedly reduced migraine days by 81% (with a reduction of over 50% in monthly migraine days). Prospective randomized controlled trials (PRIMA and PREMIUM trials) assessing the Amplatzer® PFO Occluder showed significant benefits in most secondary endpoints, with a pooled analysis indicating its safety and effectiveness compared to medical therapy.While traditional metal PFO closure studies suggest symptom relief, reports also mention potential new-onset or worsened migraines post-closure. Proposed mechanisms include platelet activation, microthrombus formation, nickel allergy, and septal deformation or stretching inducing the release of migraine-related vascular active substances. However, these theories are closely tied to the presence of permanent metal implants. Addressing these concerns, the MemoSorb® biodegradable PFO Occluder system, approved by the National Medical Products Administration (NMPA) in September 2023, offers an innovative solution. Developed collaboratively by the National Biomedical Materials Engineering Technology Research Center, Professor Wang Yunbing's team, Professor Pan Xiangbin's team from Fuwai Hospital, Chinese Academy of Medical Sciences, and HeartTech Medical, this groundbreaking technology represents a shift from metal to degradable materials. The occluder serves as a temporary bridge post-implantation, gradually degrading with endothelialization, facilitating comprehensive self-repair. This intervention concept theoretically avoids the lifelong complications associated with traditional metal occluders, effectively reducing postoperative symptoms like migraines and dizziness. To assess and compare the treatment outcomes, especially in relieving migraines, a prospective, single-blind, randomized controlled study has been designed for patients with patent foramen ovale and migraine, comparing the novel biodegradable occluder with the metal occluder.

NCT ID: NCT06200480 Recruiting - Migraine Clinical Trials

Nurse Intervention Trial

Start date: April 21, 2023
Phase: N/A
Study type: Interventional

This randomized open-label prospective study focus on headache patients initiating preventive treatment, where the treating physician identifies a need for follow-up visits in specialized healthcare. The study will clarify whether the implementation (compliance) and overall satisfaction of the patient are better with follow-up by a headache nurse compared to standard follow-up. Patients with signed written consent will be randomised to either group a: Telephone calls from nurse after two and 6 week or B. Patient-initiated follow-up by their general practitioner.

NCT ID: NCT06180070 Completed - Migraine Clinical Trials

Bioequivalence Study to Compare Ibuprofen/ Paracetamol Tablets (200mg Ibuprofen/ 500mg Paracetamol) Versus Nuromol® Tablets (200mg Ibuprofen/ 500mg Paracetamol)

Start date: August 29, 2023
Phase: Phase 1
Study type: Interventional

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Ibuprofen/ Paracetamol tablets (200mg Ibuprofen/ 500mg Paracetamol) versus Nuromol® tablets (200mg Ibuprofen/ 500mg Paracetamol) in healthy subjects under fasting condition.

NCT ID: NCT06170281 Recruiting - Migraine Clinical Trials

Sequential, Multiple Assignment, Double Randomized Preference, Migraine Behavioral Trial

SMARTMig
Start date: December 15, 2023
Phase: N/A
Study type: Interventional

This study will unpack the behavioral intervention for migraine and determine the optimum combinations. In addition, the study will test preference and self-selection effects during the trial.

NCT ID: NCT06161129 Not yet recruiting - Migraine Clinical Trials

Filter Lenses for the Prevention of Migraine Attacks

COMFORT
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The purpose is to investigate whether the Blue Cut for Night filter is better at reducing migraine compared to the FL-41 filter or a filter blocking light below 500 nm. A control group will use clear lenses without filter. This is a controlled, randomized and double-blind trial.

NCT ID: NCT06155669 Recruiting - Migraine Clinical Trials

The Use of Virtual Reality Applications in Tension-Type Headaches

Start date: December 15, 2023
Phase: N/A
Study type: Interventional

The primary aim of this research is to objectively assess the impact of virtual reality (VR) technology on pain symptoms in tension-type headache patients. This study is designed to understand the potential of VR in the treatment of tension-type headaches, exploring its ability to reduce pain severity and improve patients' quality of life.

NCT ID: NCT06149000 Not yet recruiting - Migraine Clinical Trials

Migraine Headache Mitigation Utilizing Avulux

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

This will be a randomized double blind cross over interventional trial to determine if Avulux lenses are able to reduce headache symptoms in patients