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Headache clinical trials

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NCT ID: NCT05049057 Not yet recruiting - Clinical trials for Mild Traumatic Brain Injury

Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI

Start date: October 2021
Phase: Phase 2
Study type: Interventional

This study aims to assess the effect and safety of erenumab compared to placebo for the treatment of acute posttraumatic headache (PTH) in military service members and civilians with mild traumatic brain injury (mTBI).

NCT ID: NCT05039996 Active, not recruiting - Migraine Headache Clinical Trials

Effectiveness of Education and Relaxation Program on Migraine Related Disability in Patients Attending Headache Clinic

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

Migraine causes severe impairment in quality of life (QOL) both during and between attacks. Migraine also increases absenteeism, reduces productivity at work as well as at home, disrupts social and family relationships, also is associated with increased healthcare costs. The current study aiming to evaluate the effectiveness of an integrated therapeutic patient education and relaxation training intervention in order to decrease the burden of migraine headache among adult patients attending the headache clinic in Ain Shams University Hospitals.

NCT ID: NCT05033613 Recruiting - Pain Clinical Trials

Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease

Start date: September 10, 2021
Phase:
Study type: Observational

The coronavirus SARS-CoV-2 causing COVID-19 was pandemic since 2020. Vaccination is one of the most important measure to control the outbreak. The countries of the world started the vaccination since December, 2020. Taiwan started since March, 21st, 2021. Currently, Taiwanese people receive COVID-19 vaccination by either AZ or Moderna; Pfizer/BNT vaccine may import in the near future. The side effects post vaccination including injection site pain, fatigue, headache, myalgia, chills, arthralgia, fever, and so on. Incidence of side effects more frequent in young people than elders; more frequent in the first dose than second dose in AZ vaccine; more frequent in the second dose in Moderna or Pfizer/BNT vaccine. Taiwan V-watch is a system monitored by CDC for people proactive notification of side effects post COVID-19 vaccination. But it doesn't include the objective cardiovascular parameters, for example, heart rate, arrhythmia, blood pressure, central body temperature (ear temperature) and blood oxygen saturation level. This study aims to monitor the physiologic and psychologic effects, and side effects before and after COVID-19 vaccination in patients at high cardiovascular risk, including hypertension, hyperlipidemia, and type 2 diabetes, and arrhythmia or coronary artery disease. The investigators arrange two weeks of continuous home BP/HR monitoring (7 days pre- and post-vaccination) for evaluation of physiologic effects post vaccination. Due to fever noted in some people post-vaccination, the investigators also measure ear temperature, pulse oximetry, and environmental temperature and humidity, for the reference of BP monitoring. In conclusion, this study may provide important information of cardiovascular response and psychosocial effects after SARS-CoV-2 vaccination for proactive prevention of cardiovascular complications.

NCT ID: NCT05023460 Recruiting - Pain Clinical Trials

Treatment of Chronic Cluster Headache With TENS and ONS

HortONS
Start date: August 27, 2021
Phase: N/A
Study type: Interventional

The study is an investigator-initiated, prospective, randomized, placebo-controlled, double blind clinical trial that aims to investigate the effect of transcutaneous electrical nerve stimulation (TENS) and occipital nerve stimulation (ONS) on attack frequency and severity in patients with chronic cluster headache (CH). Study outline Month 1: Baseline. Establishment of a baseline profile of the participants CH attacks (severity, duration, medicine utilization etc), health-related quality of life (QoL) and symptoms of anxiety and depression. No active treatment. Follow-up visit after 30 days. Months 2-4: TENS period. All participants will receive TENS-treatment. Clinical follow-up visit by the end of month four. Months 5-7: Double-blinded, randomized experimental period. All participants will have an ONS-system (lead, impulse generator) implanted and will be randomized 1:1 to receive either 1) burst (paresthesia-free) ONS or 2) placebo (deactivated ONS system). Clinical follow-up visit by the end of month seven. Months 8-10: Open label period. All participants will receive tonic (conventional, paresthesia-inducing) ONS. Clinical follow-up visit by the end of month ten. During every study phase each participant will fill out a weekly electronic headache registration as well as answering questionnaires regarding health-related quality of life and symptoms of anxiety and depression before every follow-up visit.

NCT ID: NCT05001399 Not yet recruiting - Chronic Pain Clinical Trials

Feasibility of Using Holographic Memory Resolution® (HMR) in Patients/Clients With Pain

Start date: August 2021
Phase: N/A
Study type: Interventional

Study Purpose: This study will explore the feasibility of administering Holographic Memory Resolution® (HMR) to adults who are experiencing chronic pain for 6 months or more.

NCT ID: NCT04993950 Recruiting - Clinical trials for Cervicogenic Headache

Effects of SNAGS Along With Thoracic Postural Correction Techniques in Patients With Chronic Cervicogenic Headache

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to find out the effects of Mulligan SNAGs along with thoracic postural correction techniques on patients with chronic cervicogenic headache. Patients suffering from cervicogenic headache are often associated with muscle imbalance. This study will be significant in determining the effects of SNAGs along with thoracic postural correction techniques to improve pain, level of disability and functional status in patients of cervicogenic headache. It will be Randomized controlled trial study design Data will be collected from Lady reading Hospital Peshawar Purposive sampling, group randomization using lottery method will be used in this study.

NCT ID: NCT04989413 Not yet recruiting - Clinical trials for Chronic Migraine, Headache

Cannabidiol 133mg + Cannabigerol 66mg + Tetrahydrocannabinol 4mg vs Placebo as Adjuvant Treatment in Chronic Migraine -

CAMTREA
Start date: August 2, 2021
Phase: Phase 4
Study type: Interventional

To evaluate the effect of the cannabidiol (CBD) + cannabigerol (CBG) + tetrahydrocannabinol (THC) up to 133/66/4mg daily versus placebo as adjuvant treatment in chronic migraine (CM) patients under preventive treatment at a stable dose for at least 3 months who present at least 5 headaches day a month. CM patients of both sexes, between 25 and 65 years old, who have not had CBD and/or THC as a migraine treatment. Patients may be having migraine preventive treatment such as propranolol, topiramate, valproic acid/sodium valproate, flunarizine, amitriptyline, nortriptyline, candesartan, galcanezumab, erenumab, fremanezumab, botulinum toxin type A. Acute treatment will follow patients doctor's prescription. Exclusion criteria: active liver disease or elevated liver transaminases> 3 times than the normal values, pregnancy, fertile age women without contraceptive treatment or who intend to get pregnant, patients without migraine preventive treatment, substance abuse or addiction, use of medical cannabis or products with CBD or THC in the last 30 days or during study period, history of allergy or adverse reactions with the use of CBD or related products, substance users of liver enzymes inducers such as rifampicin, ketoconazole, theophylline, carbamazepine, phenytoin, phenobarbital and St. John's wort. Patients on vitamin K anticoagulant medicines, as warfarin. After randomization patients will be divided into two groups of 55 participants, who will receive CBD + CBG + THC up to a maximum dose of 133/66/4 mg or placebo for 12 weeks (V0 screening, V1 allocation, V4 final visit). The main outcome is the reduction in frequency of headache days per 4 weeks between V1 and V4 compared to placebo. Secondary outcomes will be a reduction in duration and intensity of migraine attacks, amount of painkillers used and percentage of patients with a reduction greater than 50% on migraine days, 50% reduction in the other variables as MIDAS scores, HIT-6 scores, Beck's Anxiety and Depression Scales, Epworth Sleepiness Scales, and the scores at The Severity of Dependence Scale used as an indicator of overuse medication in this sample. The clinical and laboratory data obtained in this study will comply with the objectives elaborated in the evaluation of the primary and secondary, the proposal of which is to publish the data regardless of the results obtained.

NCT ID: NCT04984720 Not yet recruiting - Migraine Clinical Trials

Efficacy of Smartphone Based Digital Application in Improving Headache Related Parameters in Patients With Migraine

Start date: July 25, 2021
Phase: N/A
Study type: Interventional

Migraine is a common headache disorder and affects 1 in 5 adults during their lifetime. It is a disorder which leads to significantly impaired quality of life, absence from work, loss of productivity in workplace and reduced vitality in social functioning. One of the important cornerstones in the management of migraine is the maintenance of a good headache diary. A headache diary enables the physician to understand the headache characteristics as well to establish the triggers causing the precipitation of episodes. The other important measure to ensure good outcomes is compliance to medications in those who have been prescribed prophylaxis. Migraine prophylaxis is by pills that have to be taken everyday at fixed time to ensure best outcomes. However, it is known that patients with migraine often are not adherent to prophylactic medications. A meta-analysis of 33 studies found that observational studies (n = 14) showed adherence ranging from 41% to 95% at 2 months after initiation of medication and 21% to 80% at 6 months. Pooled rates of persistence derived from 19 RCTs on propranolol, amitriptyline, and topiramate showed adherence rates of 77%, 55%, and 57%, respectively, at 16-26 weeks of initiation. The real world adherence is expected to be lower than that in the ideal settings of randomized trials. Regular pill reminders issued through smartphone based applications can improve medication adherence and thus improve headache outcomes. Though smartphone based migraine tracker digital applications are available, they mostly are aimed at capturing headache characteristics. The efficacy of providing pill reminders along with patient educational materials and community blog to enable migraineurs share their experiences with each other has not been studied in controlled trials. It is known that patients who are well informed about their chronic diseases such as migraine often have better outcomes. Busy clinicians often resort to providing pamphlets regarding the disease, triggers, acute pain relief medications, prophylactic therapy etc. However, it is yet to be studied if a digital application with all these inbuilt features, which are easily accessible at the finger tips would lead to better information uptake and improved compliance and self management. This RCT would try to assess this gap in knowledge.

NCT ID: NCT04983186 Recruiting - Migraine Clinical Trials

mBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache

MBRAIN-21
Start date: July 19, 2021
Phase: N/A
Study type: Interventional

This study collects data from migraine and cluster headache patients during a three-month study. Contextual data (e.g. location or smartphone usage) and physiological variables will be used to assist machine learning algorithms in making predictions on activity, stress and sleep in patients with migraine or cluster headache.

NCT ID: NCT04976985 Enrolling by invitation - Migraine Disorders Clinical Trials

Osteopathic Manipulative Treatment and Migraine Headaches

Start date: October 2, 2018
Phase: N/A
Study type: Interventional

In this study the investigators hypothesize, that Osteopathic Manipulative Therapy (OMT) will reduce migraine disability and severity scores when compared to standard of care including prophylactic pharmacological agents with treatment over 12 week time frame. The investigators aim to decrease severity and disability of migraine by utilizing Osteopathic Manipulative Therapy. This would ultimately reduce the utilization of office or emergency department visits, decrease the large economic burden the United States faces for migraine patients as well as improve quality of life for the 3 million chronic migraine patients.