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Headache Disorders clinical trials

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NCT ID: NCT06267664 Recruiting - Migraine Clinical Trials

Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP)

TRIDIGEP
Start date: December 4, 2023
Phase:
Study type: Observational [Patient Registry]

Migraine is the third most prevalent disease and the leading reason of years lived with disability in the most productive years of the life. Migraine associated disability can be alleviated by acute and preventive treatment. The migraine landscape has changed recently, with the approval of novel acute treatments, including oral Calcitonin gene-related peptide antagonists, the gepants (Rimegepant, Ubrogepant, Zavegepant) and 5-HT-1F antagonists, the Ditans (Lasmiditan). These have joined Triptans as acute "migraine-specific" drugs. The TRIDIGEP study will be an open-label, multiple attack, prospective cohort study. This study aims to describe 1) the effectiveness of the acute treatments of migraine attacks in routine clinical practice, 2) the tolerability of the drugs, and 3) to explore potential response and tolerability predictors. The endpoints recommended by the International Headache Society will be employed, including: 1) Pain freedom; 2) Absence of the most bothersome symptom; 3) Sustained pain freedom; 4) Total freedom from migraine; 5) Headache relief; 6) Duration of attacks; 7) Time lost due to an attack; 8) Need of rescue medication. The study endpoints will be assessed at 2, 8 and 24 hours after the acute drug use. Data will be collected by the patients themselves, with a validated data collection instrument within a RedCap questionnaire, using QR codes.

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: 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: NCT06041997 Recruiting - Headache Disorders Clinical Trials

Smartphone Use Restriction as Treatment of Primary Headache

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to study smartphone use restriction as a treatment modality in patients of primary headache. The main question[s] it aims to answer are: 1. In patients with primary headache, does restriction of smartphone use lead to reduced consumption of medications (acute, prophylaxis, either or both)? 2. In patients with primary headache, does restriction of smartphone use lead to better responsiveness to medications (acute, prophylaxis, either or both)? 3. Can reduction of smartphone duration be used as a non-pharmacological treatment of primary headache? 4. In patients with primary headache, is the type of smartphone use (phone calls, internet browsing, watching screen) determinant of the severity of headache? 5. Can we make an addiction score to predict which patient should be advised to limit smartphone use based on the above information? 6. In patients with primary headache, does restriction of smartphone use led to improvement in headache severity (frequency, intensity, duration, one of them or all). The smartphone users may further be classified into low and high smartphone users depending upon the smartphone addiction questionnaire (SAQ) (appendix 1) usage score. SUs with 0-1 score on the SAQ were further grouped into low SUs, and patients with score ≥1 were grouped into high SUs. To create a homogenous group, only patients with high SU will be randomized to standard treatment (Arm C) and intervention group (Arm D). Participants will be asked about their smartphone usage, and if found eligible, there will be a run-in period of 4 weeks after which they will be randomized to the intervention (smartphone restriction) or comparison group (no restriction recommended)

NCT ID: NCT05889624 Recruiting - Migraine Clinical Trials

Responding With Evidence and Access for Childhood Headaches

Start date: August 22, 2023
Phase: N/A
Study type: Interventional

This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.

NCT ID: NCT05888324 Recruiting - Clinical trials for Post-Dural Puncture Headache

Factors Associated With the Onset of Chronic Headaches in Patients Who Received a Blood Patch in Post Partum

CHROBLOOD
Start date: June 6, 2023
Phase:
Study type: Observational

The purpose of this study is to identify possible links between conditions for carrying out a blood patch (BP) to treat accidental post dural puncture acute headache (PDPH) in the early post partum period and occurrence of chronic headaches at 1 and 6 months.

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: NCT05704335 Recruiting - Migraine Clinical Trials

InfluenCEF Study: Study on the Headache Associated With Influenza Infection

INFLUENCEF
Start date: December 20, 2022
Phase:
Study type: Observational

The goal of this observational analytic study with a cohort desing is to evaluate the epidemiology, risk factors and clinical phenotype of headache during Influenza infection. The study will be done in collaboration with the Healthcare Sentinel Network of Castile and Leon (Red Centinela Sanitaria de Castilla y León, RCSCYL) and the National Influenza Center of Valladolid (CNGV). First, the historical data of the VIGIRA network of the 2010-2022 flu seasons will be analyzed, assessing the epidemiology and risk factors of headache during Influenza infection; and second, a study with a case series design with prospective follow-up will be carried out for the incident cases of the 2022-2023 and 2023-2024 Influenza seasons, evaluating the clinical phenotype and the duration of the headache.

NCT ID: NCT05619354 Recruiting - Neck Pain Clinical Trials

Validity and Reliability of the Dutch HDI

Start date: November 1, 2022
Phase:
Study type: Observational

The aim of our study is to investigate the validity and reliability of Dutch version of the Henry Ford Hospital Headache Disability Questionnaire (HDI).

NCT ID: NCT05491499 Recruiting - Fibromyalgia Clinical Trials

Assessing the Impact of Exercise Based Intensive Interdisciplinary Pain Treatment (IIPT) on Endogenous Pain Modulation in Youth With Chronic Pain Syndromes

Start date: October 17, 2022
Phase:
Study type: Observational

This work will answer two critical questions: 1) Does intensive interdisciplinary pain treatment (IIPT) involving aerobic exercise help normalize pain processing in youth with chronic pain syndromes and 2) Are aerobic fitness levels and the ability to modulate pain inter-related? Currently, medications are ineffective for improving pain and disability in youth with chronic pain syndromes and identifying non-pharmacologic treatments, such as IIPT, that help strengthen the nervous system's ability to modulate or turn pain signals down will improve outcomes and quality of life for youth suffering from chronic pain. This study will help determine whether exercise based IIPT leads to physiologic improvements in how pain is processed, specifically if youth with chronic pain can better turn pain down during the offset analgesia test after an exercise based IIPT treatment, and also help elucidate the link between a child's aerobic fitness and their ability to modulate pain.